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	:	Analgesic efficacy of intravenous paracetamol plus tramadol combination for pain after laparoscopic cholecystectomy: a double-blind, randomized, placebo-controlled trial
Running head: Paracetamol plus tramadol for post-laparoscopic cholecystectomy pain
Khaled El-Radaideh1, Associate Professor of Anesthesia MD, PhD, Facharzt, elradk61@yahoo.com
Alaa Alhowary 1, Assistant Professor of Anesthesia, MD.  aaalhowary@just.edu.jo.
Diab Bani Hani1, Assistant Professor of Anesthesia, MD.  Eyas82@yahoo.com 
Adel Bataineh 1, Assistant Professor of Anesthesia, MD.  dkradadi@hotmail.com
Mohammed Bani Hani2, Associate Professor of General Surgery, MD.  bose95@rocketmail.com
1Department of Anesthesiology, 2Department of General Surgery, Faculty of Medicine, Jordan University of Science and Technology. 
POB 953   Irbid 21110
Jordan
Author to whom all correspondence and reprint requests should be made:
Dr. Med. Khaled EL- Radaideh
Associate Professor of Anesthesia
Department of Anesthesiology, Faculty of Medicine, Jordan University of Science and Technology (JUST)
POB 953
Irbid 21110
Jordan
Phone: 962-0-799051167   
E-Mail:  HYPERLINK "mailto:elradk61@yahoo.com" elradk61@yahoo.com
Abstract
Objective: To evaluate the efficacy of intraoperative intravenous paracetamol plus tramadol for early postoperative pain relief after laparoscopic cholecystectomy.
Methods: Fifty patients were randomly allocated to two groups in this prospective, randomized, double-blind, and placebo-controlled study: group PT (paracetamol plus tramadol, n=25) and group C (control, n=25). Immediately after dissection of the gallbladder, group PT received 0.75 mg/kg tramadol (in normal saline; total volume, 5 mL), followed by 1 g paracetamol (in 100 mL commercial vials) intravenously. Group C received 5 mL and 100 mL normal saline in the same manner. Pain intensity using a numerical rating score was recorded at 10 and 30 min, and 1, 2, 4, 6, 8, 12, and 24 h after surgery. The time to first analgesic and the 24-h total analgesic consumption were recorded.
Results: Postoperative pain scores were significantly lower at 10 and 30 min, and 1, 2, 4, and 6 h after surgery in group PT than in group C. At 8, 12, and 24 h postoperatively, the pain scores were similar for the two groups. Time to first rescue analgesic was significantly longer in Group PT than group C (33.8 � 7.4 vs. 14.7 � 8.4 min, respectively). Rescue analgesics were received by significantly fewer patients in group PT than group C (32% vs. 72%, respectively) and total analgesic consumption was significantly lower in group PT than group C (675 vs. 1740 mg pethidine, respectively). The incidence of postoperative nausea or vomiting did not differ significantly between groups (36% vs. 48% for groups PT and C, respectively)
Conclusion: In conclusion, intraoperative intravenous paracetamol (1 g) and tramadol (0.75 mg/kg) significantly reduced postoperative pain scores, decreased postoperative analgesic requirements, and prolonged the time to first postoperative analgesic.

Key words: IV paracetamol; IV tramadol; postoperative; pain; cholecystectomy 
Introduction
Since first reported in 1987, laparoscopic cholecystectomy has become a popular technique worldwide because of its several advantages over conventional cholecystectomy. These advantages include less pain, more rapid convalescence, earlier discharge, and more expeditious return to normal activities [1, 2]. However, patients undergoing laparoscopic cholecystectomy still experience moderate to severe pain in the abdomen or shoulder region, especially on the first postoperative day [3]. Appropriate postoperative pain management is therefore indicated.
Although opioids are generally the preferred analgesic agents during the early postoperative period after laparoscopic cholecystectomy, their use is associated with multiple adverse effects, such as nausea, vomiting, constipation, respiratory depression and delayed recovery [4, 5]. This emphasizes the need for an analgesic strategy that targets multiple sources of pain but acts quickly and has minimal side effects and few drug interactions [6]. One such strategy is the combination of the atypical opioid tramadol with the nonopioid paracetamol; this combination has become a well-established analgesia strategy in a number of settings [7, 8].
Tramadol is a weak, centrally-acting opioid analgesic. It is a racemic compound with two enantiomers, the L (+)-enantiomer and the D (-)-enantiomer, which have complementary mechanisms of action [6, 9]. The L (+)-enantiomer has a moderate affinity for mu-opioid receptors and inhibits serotonin reuptake, whereas the D (-)-enantiomer inhibits norepinephrine reuptake in pain pathways of the central nervous system (CNS) [10-13]. Potential advantages of tramadol for postoperative pain relief include its relatively long duration of action, limited respiratory depressant effects, and minimal sedative effects [14, 15].
Paracetamol is a non-opioid analgesic with antipyretic properties [16]. Although the mechanism of action of paracetamol has not yet been elucidated, its analgesic action is assumed to be mediated by serotonergic mechanisms and inhibition of prostaglandin synthesis, predominantly in the CNS rather than in peripheral tissue [17, 18]. Because of its lack of significant peripheral action, paracetamol is better tolerated than nonsteroidal anti-inflammatory drugs (NSAIDs), does not affect the bleeding time, and does not damage the gastrointestinal mucosa. However, paracetamol occasionally causes a reversible increase in hepatic enzymes [16,19]. Combining paracetamol with opioids may improve analgesia, and by lowering the required doses of both medications, tolerability may be enhanced without increasing the incidence of postoperative nausea and vomiting (PONV), respiratory depression, or renal effects associated with the use of NSAIDs [5, 20, 21].
The aim of this randomized, double-blind, placebo-controlled clinical study was to evaluate the effectiveness of the combination of intraoperative intravenous paracetamol plus tramadol for early postoperative pain relief after laparoscopic cholecystectomy. Our primary goal was to test the hypothesis that this combination would lower postoperative pain scores in the early postoperative period. The secondary endpoints were to compare the following outcomes between patients who received the combination and those who received placebo: cumulative pethidine consumption in the first 24 h postoperatively, number of patients requiring rescue analgesic, time to first rescue analgesic, and presence of postoperative nausea and vomiting.




Methods
After obtaining formal approval from our institutional ethics committee, we conducted a randomized, double-blind, placebo-controlled study involving 50 American Society of Anesthesiologists (ASA) physical status I�III adults scheduled for laparoscopic cholecystectomy under general anesthesia at the Jordan University of Science and Technology between September 2013 and January 2014. Written informed consent for participation in the study was obtained from all patients, who were blinded to their assignment group.
The inclusion criteria were older than 18 years of age and scheduled for elective laparoscopic cholecystectomy. The exclusion criteria were advanced renal disease, heart failure, or psychiatric disorders; chronic pain treatment; use of analgesics (paracetamol, NSAIDs, or opioids) within 24 h before surgery; known hypersensitivity to paracetamol, tramadol, or pethidine; or a body mass index > 35 kg/m2. Patients were also excluded if their surgery was converted to a laparotomy or if another surgical procedure was performed in addition to the laparoscopic cholecystectomy during the same anesthetic.
The patients were not premedicated. On arrival in the operating theatre, intravenous access was achieved and standard monitoring of blood pressure, heart rate (by three-lead electrocardiography), and oxygen saturation (by pulse oximetry) was begun. The blood pressure, heart rate, and oxygen saturation were monitored continuously. After the patient breathed oxygen for 3 minutes via a face mask, anesthesia was induced with 2-2.5 mg/kg propofol and 2 �g/kg fentanyl. To facilitate tracheal intubation, neuromuscular blockade was achieved with 0.5 mg/kg atracurium. Anesthesia was maintained with 1.5-2% sevoflurane in 50% oxygen and air. Additional doses of fentanyl or atracurium were administered as required. No fentanyl was not administered within the last 15 min of the procedure. The airway was maintained throughout the surgery with an endotracheal tube. The lungs were ventilated with volume-controlled mechanical ventilation using a tidal volume of 8-10 mL/kg and a respiratory rate adjusted to maintain the end-tidal carbon dioxide between 35 and 40 mmHg.
Patients were allocated randomly, in a double-blind manner using the sealed envelope method, into two groups: group PT (n = 25) received the combination of intravenous 1 g paracetamol (Perfalgan� 1g/100 ml solution for infusion vials, Bristol-Myers Squibb LOC, Anagni, Italy, ) plus 0.75 mg/kg tramadol (Tramal� Gruenthal, Germany), and group C (control group, n = 25) received an equal volume of intravenous normal saline. Randomization was based on computer-generated codes, which were maintained in sequentially numbered opaque envelopes. The envelopes were opened immediately before the induction of anesthesia by an anesthesiologist who was not involved in administering the anesthetic or evaluating the study results. This anesthesiologist prepared and administered all study drugs. The tramadol solution was prepared by first placing one ampoule of Tramal� (containing 100 mg tramadol) in a 5 ml syringe and adding normal saline to obtain a total volume of 5 ml; each mL thus contained 20 mg tramadol. The calculated dose of tramadol for each individual patient (0.75 mg/kg) was taken from this solution and placed in another 5 ml syringe, to which normal saline was added to obtain a total volume of 5 ml.
The patients in both groups received the assigned study drugs immediately after dissection of the gallbladder. Patients in group PT received the 5 mL tramadol in normal saline solution as a slow intravenous injection over approximately 20 seconds, followed by 1 g Perfalgan� in 100 mL as an intravenous infusion over 10 min. Patients in group C received 5 mL normal saline as a slow intravenous injection, followed by infusion of 100 mL normal saline over 10 min.
At the conclusion of the operation, the anesthetic agents were discontinued and residual neuromuscular block was reversed with 2.5 mg neostigmine and 1.0 mg atropine. The endotracheal tube was removed when the patient regained consciousness and exhibited regular respirations, with an adequate rate and volume. 
Pain intensity was assessed by the patient and recorded by the anesthesiologist 10 min and 30 min after arrival in the post anesthesia care unit (PACU) and at 1, 2, 4, 6, 8, 16 and 24 h postoperatively. Pain scores were rated using the numerical rating score (NRS) (0, no pain, to 10, worst pain imaginable). 
Postoperatively, 1 mg/kg pethidine was used as a rescue analgesic if the NRS was 4 or higher or if an analgesic was requested by the patient. In the recovery room, 25 mg of the calculated pethidine dose was administered intravenously and the remainder of the calculated dose was injected intramuscularly. For pethidine administered after discharge from the PACU, the entire calculated dose was administered as an intramuscular injection by the in-charge staff nurse, who was blinded to the study group assignment; this nurse recorded the pain intensity regularly when the patient requested an analgesic. A blinded observer recorded the time to first pethidine postoperatively, cumulative pethidine consumption in the first 24 h postoperatively, presence or absence of shoulder pain, and incidence of side effects (nausea and vomiting).
Patients with PONV received 10 mg metoclopramide intravenously. The verbal rating scale of Sandhu et al. [1] was used to assess PONV: 0 (none), 1 (nausea), 2 (nausea with vomiting), or 3 (repeated vomiting e" 2 episodes/h). 
Statistical analyses:
The primary endpoint of the study was the difference in repeated postoperative pain scores between the treatment group and the placebo group. To estimate the appropriate sample size, we referred to the pain score standard deviation obtained in a previous study and found it to be within 1.2 of the mean scores [22]. To detect a difference of 1 on a 11-point NRS scale between two groups in a study with 9 repeated time measurements, a minimum of 23 patients per group would be required to achieve a power of 80% for a Type I error of 0.05. A group size of 25 was thereby chosen to allow for possible dropouts. 

Data are presented as mean � standard deviation, percentage, or absolute number. Patient noncategorical characteristics, surgery duration, time to first analgesic postoperatively, and total pethidine consumed postoperatively were analyzed using analysis of variance. Chisquare tests were used for comparisons of categorical demographic data and the occurrence of PONV. A generalized linear model for repeated measures was used to test for differences in pain score within and between groups. Bonferroni correction was applied for all comparisons. Statistical analyses were performed using SPSS 17.0 for Windows (SPSS Institute, Chicago, IL). P values less than 0.05 were considered statistically significant.







Results 
All enrolled patients completed the study, and data from all 50 patients were included in the analysis. There were no significant differences between groups for gender, age, weight, height, or ASA physical status (Table 1). The duration of surgery was 50.7 � 11.0 min and 52.6� 9.2 min for group PT and group C, respectively (P > 0.05).
Overall, the mean postoperative pain scores were significantly lower for group PT than group C (P < 0.05, Figure 1). At 10 min, 30 min, 1 h, 2 h, 4 h, and 6 h after the conclusion of surgery, the pain scores were significantly lower for group PT than group C (P < 0.05), whereas there were no significant differences between groups at 8 h, 12 h, and 24 h postoperatively (P > 0.05). During the first 24 h postoperatively, rescue analgesics were received by significantly fewer patients in group PT (8 [32 %]) than group C (18 [72%]) (P < 0.05). As well, the time to first rescue analgesic was significantly longer for group PT than group C (33.8 � 7.4 vs. 14.7 � 8.4 min, respectively), and the total pethidine received in the first 24 hours after surgery was significantly lower in group PT (P < 0.05) (Table 2). The number of patients who experienced shoulder pain did not differ between groups (7 and 12 patients for groups PT and C, respectively) (Table 3).
The incidence of PONV did not differ significantly between groups. One patient in group PT and 3 patients in group C vomited more than two times after surgery (Table 3). No serious complications or life-threatening events occurred in either group.




Discussion
Although laparoscopic surgery produces substantially less severe discomfort than the corresponding open procedure, pain associated with laparoscopy can still be considerable [22]. Pain in the early period after laparoscopic cholecystectomy arises from several mechanisms, including abdominal wall trauma, intra-abdominal trauma, abdominal or peritoneal distension, and pneumoperitoneum using carbon dioxide [23].
Tramadol, an analgesic with a mean potency one tenth that of morphine, is a racemic mixture of two complementary enantiomers (L (+) and D (-) enantiomers), which act in different but synergistic ways to provide pain relief [23, 24]. The analgesic effect of tramadol is attributed to the opioid receptors with a weak affinity (6000 times less than morphine), whereas its metabolite O-desmethyltramadol has a 200 times higher affinity for mu-receptors than that of the parent drug [25, 26]. Freye et al [24] reported that L (-) tramadol interacts with monoenergetic binding sites, which enhance the inhibitory activity of the descending pain pathway, resulting in suppression of transmission at the spinal level. 
Despite decades of research, the precise mechanism of action of paracetamol has not yet been well defined. In particular, it is still under discussion whether paracetamol acts centrally and/or peripherally, and which analgesic pathways are primarily affected by the drug. With its prominent analgesic and antipyretic effects, paracetamol is one of the most commonly used agents for relieving mild to moderate pain. Paracetamol is thought to inhibit or modulate mediators of pain peripherally at the site of injury, and there is increasing evidence that paracetamol acts at the level of the CNS to produce analgesia, likely by inhibiting CNS prostaglandin formation [27]. Furthermore, paracetamol blocks the nitric oxide pathway mediated by substance P and N-methyl-D-aspartate [28]. In addition, it has been proposed that paracetamol indirectly stimulates spinal serotonin pathways and has a cannabinoid agonist mechanism, which may contribute to its analgesic effects [29, 30]. Paracetamol is particularly advantageous because it can be administered intravenously before or during surgery, permitting the initiation of effective analgesic therapy in the early postoperative period [31, 32]. In this study, we administered the combination of intravenous paracetamol plus tramadol during surgery because therapeutic plasma concentrations of paracetamol are achieved within 20 min of intravenous administration. Paracetamol�s analgesic effects persist for approximately 2 h [33]. 
The primary objective of this study was to evaluate the intensity of postoperative pain using a single dose of intraoperative intravenous paracetamol plus tramadol, which is a combination that frequently used at our institution for patients undergoing laparoscopic surgery. We found that this combination markedly reduced pain intensity from the end of surgery to 6 hours postoperatively; for the first 6 hours, the numerical pain scores of the paracetamol plus tramadol group were significantly lower than those of the control group. This finding is consistent with the results of the prospective, randomized, double-blind study by Hong et al. [34], which examined the effects of paracetamol in 124 women undergoing endoscopic thyroidectomy. In this study, the treatment group patients received intravenous paracetamol 1 h before induction of anesthesia, followed by repeat injections every 6 h for the following 24 h. Pain scores at 1 h, 3 h, 6 h, and 24 h postoperatively were significantly lower in the paracetamol group than the placebo group.
Many studies have reported that by combining drugs with different mechanisms of action and pharmacokinetic profiles, one can enhance efficacy, even with lower doses of the individual drugs [35]. In vivo studies in mice have demonstrated that co-administration of paracetamol and tramadol produces genuine synergy over a range of doses [36]. The results of our study confirm the analgesic efficacy of this combination of medications in patients undergoing laparoscopic cholecystectomy.
In our study, we chose to administer the combination of paracetamol plus tramadol immediately after dissection of the gallbladder. This timing may have contributed substantially to the PT group�s low pain scores and small number of patients receiving rescue analgesics during the PACU stay. Emir et al. [37] performed a randomized, prospective study of 60 patients which compared the effect of intravenous 0.75 mg/kg tramadol plus 1 g of paracetamol (group p) with that of 1.5 mg/kg tramadol alone (group T). These study medications were given intraoperatively. Immediately after surgery a patient control analgesia device was inserted and the patients were transferred to a recovery room, where tramadol was continuously infused, whereas 1 g of paracetamol was injected intravenously every 6 hours in group p.  The results revealed significantly lower pain scores at 0 and 15 minutes postoperatively in a group of patients receiving paracetamol and tramadol than patients receiving tramadol alone
This contrasts with the findings of Nimmaanrat et al. [38], who reported similar pain intensity in the first postoperative hour in patients receiving tramadol or placebo; in that study, tramadol was administered before surgery.. By contrast, Ali et al. [22], whose patients received tramadol or tramadol plus paracetamol at induction of anesthesia, reported that the highest pain scores were observed at 30 minutes postoperatively, and all patients required rescue analgesics. 
In our analysis of the secondary outcome measures of the analgesic efficacy of the paracetamol plus tramadol combination, we found that the time to first postoperative analgesic was significantly longer and the total quantity of opioid received during the first 24 h postoperatively was significantly less in patients receiving the combination, compared to those receiving placebo. These results are consistent with those of several previous studies demonstrating that the administration paracetamol, tramadol, or a combination of both for preemptive analgesia extends the time to first request for analgesic and reduces the quantity of analgesic administered postoperatively [22, 23,, 38-41] 
The most frequent adverse effects of tramadol and other postoperative opioids are nausea, vomiting, drowsiness, and dry mouth [42]. In our study, the incidence of PONV did not differ significantly between the paracetamol plus tramadol and placebo groups: the incidences were 36% and 48%, respectively. Similar to our finding were the results of  Rawal et al. [43], who previously reported incidences of 26% for nausea and 7% for vomiting in patients treated with paracetamol plus tramadol, and 36% and 21%, respectively, in those treated with tramadol. Ali et al. [22] found a substantially lower incidence of nausea and vomiting (6%) in their paracetamol plus tramadol group, but a high incidence of nausea (30%) and vomiting (20%) in their tramadol alone group. By contrast, Arici et al. [44] reported a 21% incidence of nausea and vomiting in their paracetamol group and a 67%, incidence in their placebo group. The highest incidences of nausea and vomiting we found in the literature were reported recently by Arslan et al [39], who examined the use of paracetamol for laparoscopic cholecystectomy. These authors noted nausea incidences of 72% in their placebo group and 48% and 25% in their two paracetamol groups (who received paracetamol at the end and beginning of surgery, respectively), and vomiting incidences of 50% in their placebo group and 27% and 12% in the corresponding paracetamol groups. 
These observations demonstrate that the incidence of PONV is variable, which is likely at least partly attributable to its multifactorial etiology. For example, the type of anesthesia, including the use of nitrous oxide, may play an important role in increasing the risk of PONV [39]. We avoided nitrous oxide in our study. One must also consider the gender of patients when examining the incidence of PONV. Young women undergoing laparoscopic surgery have a generally higher incidence of PONV than other population groups [22].
Although administering the combination of paracetamol plus tramadol during the late intraoperative period (immediately after dissection of the gallbladder) appeared to be beneficial for early postoperative analgesia, its effects on emergence from anesthesia are not known. Administration at this stage may potentially delay emergence from anesthesia. We did not evaluate PACU Aldrete scores or the time to reach PACU discharge criteria; therefore, we do not know whether emergence was affected. This limitation of the present study should be noted and taken into consideration when designing future studies.
In conclusion, the combination of intraoperative intravenous paracetamol (1 g) plus tramadol (0.75mg/kg) produced significantly lower postoperative pain scores, lower opioid consumption, and longer duration to first postoperative analgesic, compared to placebo. Therefore, administering intravenous paracetamol plus tramadol intraoperatively is a useful strategy to control acute postoperative pain after laparoscopic cholecystectomy.
Acknowledgments relating to this article
Assistance with the study: The authors would like to thank all patients who agreed to participate in this research and also all the physician and nursing staffs in the operating room, recovery room, and surgery wards at King Abdullah University Hospital. The authors acknowledge Professor Smadi (statistician) for his help with the statistical aspects of this study.
Financial support and sponsorship: ---All authors have no financial ties to disclose.
Conflicts of interest: All authors have no conflicts of interest to disclose.
Presentation: none.












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Table 1. Patient demographics and duration of surgery Patient demographics and duration of surgeryParacetamol plus tramadol
group (n = 25)  Control
group (n = 25)P valueAge (years)39.0 � 16.248.6 � 16.4*Gender (male/female)5/206/19*Weight (kg)77.6 � 13.680.8 � 15.3*Height (cm)163.9� 9.2164.1 � 15.3*ASA physical status I/II/III17/4/412/7/6*Duration of surgery (minutes)50.7 � 11.052.6� 9.2*Data are mean � standard deviation for age, weight, height, and duration of surgery, and absolute number of patients for gender and ASA physical status. 
Abbreviations: ASA, American Society of Anesthesiologists. *P value > 0.05 (not significant).


Table 2. Analgesic requirements and pain scores before administering rescue analgesicParacetamol plus tramadol group
(n = 25)Control group
(n = 25)P value*Number of patients receiving rescue analgesic8 (32%)18 (78%)0.028Time to first rescue analgesic (minutes)33.8 � 7.414.7 � 8.40.022Total pethidine received in the first 24 h postoperatively (mg) 67517400.014pain scores before administering rescue analgesic4.7 � 1.05.3 � 1.30.012
Data are absolute number of patients (percentage), mean � standard deviation, or absolute value.
Pain scores were rated by the numeric rating scale (0, no pain, to 10, worst pain imaginable). 
* P value < 0.05 is considered statistically significant.

Table 3. Postoperative shoulder pain and incidence of nausea and vomiting throughout the first 24 hours postoperativelyParacetamol plus tramadol group
(n = 25)Control group
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Nausea and vomiting is graded as the following: 0, none; 1, nausea; 2, nausea with vomiting; or 3 repeated vomiting (e" 2 times/h). The frequency of shoulder pain and the overall occurrence of nausea and vomiting were not significantly different among the 2 groups.
Figure 1: Pain intensity in the postoperative study period (mean � SD).* NRS is significantly lower in PT `!`5`=`F`qcTT$d�$Ifa$gd�%Gd��$Ifgd�%G�kdt$$IfT�c��6�F�S`"��������������������������
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h5y:h5y:UaJh�6�CJOJQJ^JaJU'h�=h{Z�CJOJQJZ�^J_H,aJ h�=h�!�CJOJQJ^JaJ h�=h{Z�CJOJQJ^JaJh{Z�CJOJQJ^JaJh��CJOJQJ^JaJh�9�CJOJQJ^JaJ)h�D�h|}�B*CJOJQJ^JaJph� h�o�h|}�CJOJQJ^JaJh��CJOJQJ^JaJ(c*c,cvtxtzt{t}t~t�t�t�t��{qgegegeg	d��gd��	d��gd{Z�d��7$8$H$gd�(�dh�7$8$H$gds"gkd^$$IfT�c���`"`"�������������0�������`"�������������������2�
a�yt|}��T vs. C group *P<0.05. # NRS: similar in both groups, #P>0, 05. Average: PT 2.5 � 1.5 vs. C group 3.2 � 1.5; *P<0.001.









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