Effect of Pre-Incisional Intravenous Paracetamol-Ibuprofen on Post-Laparoscopic Shoulder Pain After Laparoscopic...

Background: This study was designed to evaluate the analgesic effect of pre-incisional intravenous administration of a fixed-dose combination of paracetamol and ibuprofen (Maxigesic^®; Kyungbo Pharmaceutical, Seoul, Republic of Korea), with particular attention to post-laparoscopic shoulder pain (PLSP), in patients undergoing laparoscopic cholecystectomy (LC). Methods: Patients undergoing LC were enrolled in a double-blind randomised controlled trial and assigned in a 1:1 ratio to receive either normal saline (control group) or Maxigesic^® (study group). According to group allocation, normal saline or Maxigesic^® was administered intravenously over 15 min before surgical incision. PLSP, pain severity assessed using a visual analogue scale, and the proportion of patients requiring rescue analgesia for postoperative pain were evaluated during the post-anaesthetic care unit (PACU) stay (T_PACU), from PACU discharge to 24 h after discharge (T_24h), and from 24 to 48 h after PACU discharge (T_48h). Results: The two groups had comparable demographic characteristics. Abdominal-pain scores were significantly lower in the study group during the early postoperative period. The incidence of PLSP was significantly lower in the study group at T_PACU and T_24h (T_PACU: 16/58 in the control group vs. 5/58 in the study group, p = 0.014; T_24h: 23/58 vs. 9/58, p = 0.006), with an absolute risk reduction of 24.1 percentage points (95% confidence interval, 8.5-39.8) during T_24h. Among patients who developed PLSP, shoulder-pain severity did not differ significantly between the groups. A significantly lower proportion of patients in the study group required rescue analgesia for postoperative pain. No patient in either group reported PLSP at T_48h. There were no significant differences between the two groups in postoperative nausea and vomiting. Conclusions: Pre-incisional intravenous administration of a fixed-dose paracetamol-ibuprofen combination was associated with a lower incidence of PLSP and a lower proportion of patients requiring rescue analgesia in patients undergoing LC, although shoulder-pain severity among patients who developed PLSP was not significantly reduced.