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

NCT07500454 | Completed

• 1 other identifier: ISSSTE RPI #403-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Acute Pain

Keywords

Postoperative pain; Acute pain; NSAIDs; Tramadol; Ketorolac; Diclofenac; Pilot; RTC

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain). Between-group comparisons performed at each time point using Kruskal-Wallis tests with Dunn post-hoc correction.

  At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.

Secondary Outcomes (3)

• Categorical pain intensity by Verbal Rating Scale (VRS)

  At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.

• Rescue morphine consumption

  At 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.

• Incidence of hypersensitivity reactions

  Throughout the 90-minute observation period

Study Arms (3)

TRAM

ACTIVE COMPARATOR

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.

Drug: Tramadol

KETO

ACTIVE COMPARATOR

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.

Drug: Ketorolac

DICLO

ACTIVE COMPARATOR

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.

Drug: Diclofenac

Interventions

Tramadol DRUG

Tramadol 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision.

TRAM

Ketorolac DRUG

Ketorolac 60 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision.

KETO

Diclofenac DRUG

Diclofenac 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision.

DICLO

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ISSSTE Hospital Regional "Gral. Ignacio Zaragoza": lead

Study Sites (1)

Hospital Regional "General Ignacio Zaragoza," ISSSTE

Mexico City, Mexico City, 09360, Mexico

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Tramadol; Ketorolac; Diclofenac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Head and Coordinator of Anesthesiology Graduate Program, Principal Investigator

Model Details: Three-arm parallel-group pilot RCT. Participants were randomised equally (n=10 per group) to receive tramadol 150 mg IV, ketorolac 60 mg IV, or diclofenac 150 mg IV as premedication 45 minutes before skin incision.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 30, 2026
• Study Start: June 20, 2024
• Primary Completion: July 23, 2024
• Study Completion: July 26, 2024
• Last Updated: May 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Beginning at the time of article publication, with no end date.
• Access Criteria: Data and code will be publicly available with no access restrictions via GitHub.

Locations

ME (1)