Effect of Pre-Incisional Intravenous Paracetamol-Ibuprofen on Post-Laparoscopic Shoulder Pain After Laparoscopic Cholecystectomy: A Double-Blind Randomised Controlled Trial
Abstract
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 (TPACU), from PACU discharge to 24 h after discharge (T24h), and from 24 to 48 h after PACU discharge (T48h). 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 TPACU and T24h (TPACU: 16/58 in the control group vs. 5/58 in the study group, p = 0.014; T24h: 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 T24h. Among patients who…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial
- Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial
- Comparison of the Post-Caesarean Analgesic Effect of Adding Dexmedetomidine to Paracetamol and Ketorolac: A Randomized Clinical Trial
- A triple-blind randomized clinical trial of different associations between dexamethasone and non-steroids anti-inflammatories for preemptive action in third molar extractions
- An open label randomized clinical trial of Indomethacin for mild and moderate hospitalised Covid-19 patients
- Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.