Pre-emptive analgesia for laparoscopic surgery. a randomized, double-blind, placebo-controlled comparison between parecoxib sodium and tramadol

ABSTRACT

This study was performed to compare the preemptive effect of intravenous parecoxib vs intravenous tramadol as regards control of stress response to intubation and efficacy of analgesia, in adult patients undergoing laparoscopic surgery. Forty five adult patients ASA physical status I-II scheduled to undergo abdominal laparoscopic surgery were included in this study. Patients were randomly divided into three equal groups. Group I [n = 15] received parecoxib [40 mg iv]. Group II [n = 15] received tramadol [100 mg iv]. Group III [n = 15] received placebo [10 ml normal saline iv]. Anesthesia was induced 10 minutes later using propofol [2 mg/kg] and fentanyl [1-2 micro g/kg]. Tracheal intubation was facilitated using succinyl choline [1.5 mg/kg]. Maintenance of anesthesia was achieved using isoflurane [0.6% - 1.5% according to blood pressure] in a mixture of 50% N[2]O in oxygen. Intraoperative muscle relaxation was maintained using atracurium [0.5 mg/kg followed by 0.1 mg/kg every 20 min]. Mechanical ventilation parameters were adjusted to maintain end-tidal CO[2] [ETCO[2]] at normal levels. Surgery was performed using standard techniques. Catecholamine levels [adrenaline and noradrenaline] were measured 1 minute before and 1 minute after intubation. Heart rate [HR], systolic [SBP] and mean arterial blood pressures [MBP] were recorded 1 minute before, and then every 1 minute after intubation, for 5 minutes. Postoperatively, patients received a continuous infusion of iv morphine at a rate of 0.03 mg/kg/hr. When requested, an additional [rescue] dose of morphine was administered at a dose of 0.05 mg/ kg, to a maximum of one rescue dose per 6 hours. The time till request of the first rescue dose, the number of rescue doses given, and the total rescue morphine dose given were recorded. Patients were observed for the first 24 hrs after surgery for occurrence of nausea and/or vomiting, and pruritis. Data was recorded at 8 hour intervals [8, 16 and 24 hrs after surgery]. There were no intergroup differences as regards age, gender, height or weight. Time to intubation, duration of surgery, doses of propofol and fentanyl used were also similar in-between the groups. Catecholamine levels increased significantly from baseline after intubation in all groups [P < 0.05], but the increase was significantly less in group II [tramadol] than in group I [parecoxib], and both study groups showed a lesser increase compared to placebo [P < 0.05]. Relative to baseline, HR, SBP and MBP increased significantly after intubation in all groups. This increase was significantly greater in group III [P < 0.05]. The tramadol group showed a slightly lesser increase in HR, SBP and MBP compared to the parecoxib group [P < 0.05], but these differences were not clinically significant. Patients in the parecoxib group showed a longer time [median] to first request of rescue analgesia [11.6 hrs] as compared to the tramadol group [7.2 hrs]. Both groups were superior to placebo [3.9 hrs to rescue dose, P < 0.05]. A similar trend was shown in the number, and total dose of rescue morphine, in-between the groups. Nausea and/or vomiting was greatest in the tramadol group [P < 0.05], and more pronounced in all groups in the first 8 hours after surgery. Pruritis was an isolated finding in the tramadol, group; none of the patients in the other two groups complained of pruritis. Both parecoxib and tramadol are effective agents as preemptive analgesics for laparoscopic surgery. While tramadol can have a more stable hemodynamic profile, parecoxib provides a more intense analgesic effect, with a hemodynamic profile that is not clinically inferior to tramadol. The use of tramadol, however, can be associated with more side effects, such as nausea, vomiting, and pruritis