Analgesic Equivalence of NSAIDs and a Weak Opioid in Acute Postoperative Pain Following Minimally Invasive Surgery Under Balanced General Anaesthesia: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This pilot randomised controlled trial compared the analgesic equivalence of three intravenous premedication regimens - tramadol 150 mg, ketorolac 60 mg, and diclofenac 150 mg - in adult patients undergoing elective minimally invasive surgery under balanced general anaesthesia. The primary outcome was postoperative pain intensity measured using the Numerical Rating Scale (NRS 0-10) at recovery room arrival and at 30, 60, and 90 minutes thereafter.
详细描述
Acute postoperative pain remains inadequately managed in a substantial proportion of surgical patients, with particular challenges in resource-limited settings where access to potent opioids is restricted. Cross-class equianalgesic data comparing NSAIDs with weak opioids are scarce. This single-centre, double-blind, parallel-group pilot RCT was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Thirty adult patients (ASA I-II, age 18-55 years, BMI 18.5-34.99 kg/m²) scheduled for elective laparoscopic surgery were randomised equally to receive tramadol 150 mg IV, ketorolac 60 mg IV, or diclofenac 150 mg IV, administered 45 minutes before skin incision. All patients received standardised balanced general anaesthesia. Pain was assessed using the NRS and Verbal Rating Scale (VRS) at five time points. Rescue analgesia (morphine 3 mg IV) was available on request. The trial was initially registered with the ISSSTE institutional research registry (RPI #403-2024).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Study drugs were prepared in identical 100 mL 0.9% saline bags by personnel not otherwise involved in the study and delivered unlabelled to the responsible anaesthesiologist, ensuring blinding of both the investigator and the patient.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years
- •ASA physical status I or II
- •Body mass index 18.5-34.99 kg/m²
- •Scheduled for elective minimally invasive surgery under balanced general anaesthesia
- •Pre-surgical pain NRS = 0 and VRS = "absence" at baseline assessment
排除标准
- •Pregnancy
- •Known hypersensitivity to any study drug (tramadol, ketorolac, or diclofenac)
- •Pre-existing acute pain with NRS ≥ 4 or VRS ≥ "moderate" before surgery
- •Chronic pain with current analgesic use
- •Withdrawal of consent before premedication administration
- •Surgical duration exceeding 180 minutes
- •Conversion from laparoscopic to open surgical approach
- •Hypersensitivity reaction during study drug administration
- •Haemodynamic shock of any aetiology during the perioperative period
- •Requirement for postoperative mechanical ventilation due to anaesthetic-surgical complications
研究组 & 干预措施
TRAM
Participants received tramadol 150 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions.
干预措施: Tramadol (Drug)
KETO
Participants received ketorolac 60 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions.
干预措施: Ketorolac (Drug)
DICLO
Participants received diclofenac 150 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions.
干预措施: Diclofenac (Drug)
研究者
Mirna Magali Delgado Carlo
MD, Head and Coordinator of Anesthesiology Graduate Program, Principal Investigator
ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"