NCT07500454

Analgesic Equivalence of NSAIDs and Tramadol in Acute Postoperative Pain Following Minimally Invasive Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" · Other Government
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Postoperative Pain
• Acute Pain

Interventions

Type	Name	Description
DRUG	Tramadol	Tramadol 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision.
DRUG	Ketorolac	Ketorolac 60 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision.
DRUG	Diclofenac	Diclofenac 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision.

Timeline

• Start date: 2024-01-03
• Primary completion: 2024-03-20
• Completion: 2024-03-23
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Mexico