Comparison of Paracetamol vs. Paracetamol Nefopam Combination vs. Paracetamol Tramadol Combination Intravenous Infusion for Intraoperative and Immediate Postoperative Analgesia for Laparoscopic Cholecystectomy

Abstract

Background: Pain during and immediately after laparoscopic cholecystectomy is still troublesome for the patients despite the fact that it’s significantly less than that for open procedure. As such pain is multimodal, so the use of drugs that act by different mechanisms is expected to be more effective.
Objectives: to discover if Paracetamol alone, Paracetamol and Nefopam or Paracetamol and Tramadol combinations is more effective for intra and immediate postoperative pain control for laparoscopic cholecystectomy.
Patients and Methods: 90 patients were randomly selected among those presented for elective laparoscopic cholecystectomy at Al-Sader Medical Teaching Complex in Najaf Governorate/Iraq to participate in this prospective double blinded controlled randomized clinical trial from august 2017 to January 2018. Preoperatively, complete medical history was recorded, detailed physical examination performed and laboratory investigations assessed. The standard monitoring are non-invasive blood pressure, pulse rate, O2 saturation, ECG and capnography were applied. The patients were monitored continuously from the time just before induction of anesthesia until discharge from the post anesthetic care unite (PACU), while the study variables were recorded every 5 minutes intervals. Drugs side effects are also observed. All groups received Paracetamol i.v infusion started with the induction of general anesthesia. Group A received placebo, group B received nefopam, while group C received tramadol by slow i.v injection. The researcher was responsible for patient allocation into the specified groups and the preparation of the drugs under study. Neither the anesthesiologist nor the patient knew which drug was administered.
Results: All the baseline characteristics of the patients in the three studied groups have no statistically significant difference in all comparisons. Intraoperatively, there was no significant difference among the three groups in all comparisons of all of the variables that are observed (P value >0.05). Postoperatively, the pain score was significantly lower in group B (Nefopam group) than groups A and C (P value <0.001). Similarly, the effect size for group B is significantly lower in group B (0.28) than group A (0.95) and group C (0.9) (P value 0.025). All the other variables observed were not significantly different among all of the three studied groups. No patient suffered from side effect of any of the study drugs.
Conclusion: Intraoperative Paracetamol Nefopam combination is more effective in relieving immediate postoperative pain for elective laparoscopic cholecystectomy than Paracetamol and Paracetamol Tramadol combination without any mentionable side effects.
Recommendations: We recommend to use Paracetamol Nefopam combination for immediate postoperative pain control for elective laparoscopic cholecystectomy in the absence of contraindications.