Role of Preoperative Tapentadol in Reduction of Peri-operative Analgesics Requirements After Breast Conservative Surgery in Cancer Patients: A Randomized Controlled Trial.

Abstract

Introduction: Tapentadol, a centrally acting μ-opioid receptor agonist and noradrenaline reuptake inhibitor, has shown promise in providing potent analgesia with fewer opioid-related side effects. This study evaluated its role as a pre-emptive analgesic in cancer patients undergoing breast conservation surgery.

Materials and methods: A prospective, double-blinded, randomized controlled trial was conducted on 70 American Society of Anesthesiologists class II adult females, scheduled for conservative breast surgery, randomized into two groups after informed consent. Group A received 75 mg oral tapentadol, and Group B an oral placebo, one hour before induction. Intraoperatively, more than 20% increase in mean arterial pressure from baseline, and postoperatively, pain score (at 1, 2, 3, and 4 hours) greater than 3 was treated with intravenous morphine (up to 0.1 mg/kg). Data regarding total morphine used (dose and number of patients) intra-operatively and postoperatively, time to first rescue dose, and pain scores postoperatively, and side effects were documented.

Results: Mean intraoperative morphine requirement was significantly lower in the tapentadol group (1.11 ± 1.53 mg) compared with the placebo group (3.36 ± 1.60 mg; p < 0.001). Only 13 (37.1%) patients in the tapentadol group required intraoperative morphine compared to 31 (88.6%) in the placebo group (p < 0.001). Postoperative pain scores were lower in the tapentadol group at 1 hour (1.89 ± 0.83 vs 2.46 ± 1.15, p = 0.020) and 3 hours (1.06 ± 0.24 vs 1.23 ± 0.43, p = 0.042). Rescue morphine use post op was lower in the tapentadol group [5 (14.3%) vs.10 (28.6%), p = 0.145] with a longer time to first rescue dose (58.0 ± 21.7 vs. 43.5 ± 27.3 minutes, p = 0.290).

Conclusion: Pre-emptive tapentadol administration significantly reduced perioperative morphine use and improved postoperative pain scores at certain time points. However, the increase in time to first rescue analgesia was not statistically significant.