Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery

NCT07587645 | Completed

• 1 other identifier: ISSSTE RPI #386-2024
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomised controlled trial compared 72-hour oral premedication with tapentadol (50 mg every 12 hours) versus pregabalin (75 mg every 24 hours) for preventing acute postoperative pain in 46 patients undergoing elective lower limb surgery under neuraxial anaesthesia. The primary outcome was pain intensity measured by the Numeric Rating Scale (NRS 0-10) at PACU arrival and at 30, 60, 90, and 120 minutes thereafter. Secondary outcomes included Verbal Rating Scale scores, rescue morphine consumption, and safety (nausea/vomiting, hypersensitivity).

Conditions

Lower Limb Surgery; Acute Postoperative Pain

Keywords

Tapentadol; Pregabalin; Preemptive analgesia; Acute postoperative pain; Lower limb surgery; Neuraxial anesthesia; Pilot randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Pain intensity by Numeric Rating Scale (NRS)

  Postoperative pain intensity measured using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain). The primary longitudinal analysis used a linear mixed model with Group, Time, and Group×Time interaction as fixed effects and a random intercept per patient. Between-group contrasts at each timepoint were derived from estimated marginal means with Holm correction. Effect sizes reported as Cohen's d.

  At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival

Secondary Outcomes (4)

• Verbal Rating Scale (VRS) pain category

  At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival

• Rescue morphine consumption

  During the two-hour PACU observation period (T0-T4)

• Incidence of nausea and vomiting

  During the two-hour PACU observation period (T0-T4)

• Hypersensitivity reactions

  From first dose of study medication through 24 hours post-surgery

Study Arms (2)

Tapentadol

EXPERIMENTAL

Oral tapentadol 50 mg every 12 hours for 72 hours before surgical incision (total daily dose 100 mg).

Drug: Tapentadol

Pregabalin

ACTIVE COMPARATOR

Oral pregabalin 75 mg every 24 hours for 72 hours before surgical incision (total daily dose 75 mg).

Drug: Pregabalin

Interventions

Tapentadol DRUG

Tapentadol 50 mg immediate-release oral tablet administered every 12 hours for 72 hours preoperatively (total of 6 doses).

Tapentadol

Pregabalin DRUG

Pregabalin 75 mg oral capsule administered every 24 hours for 72 hours preoperatively (total of 3 doses).

Pregabalin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years
• ASA physical status I or II
• Body mass index between 18 and 35 kg/m²
• Scheduled for elective lower limb surgery under neuraxial anaesthesia
• Willing to provide written informed consent

You may not qualify if:

• Chronic use of analgesics or gabapentinoids
• Known hypersensitivity to tapentadol or pregabalin
• Pre-existing chronic pain
• Elimination Criteria:
• Hypersensitivity reaction to any study drug during administration
• Hemodynamic shock of any etiology
• Requirement for advanced airway management or postoperative mechanical ventilation
• Surgical duration exceeding 120 minutes
• Requirement of an epidural catheter dose within the first two postoperative hours
• Voluntary withdrawal of consent at any point

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

Interventions

Tapentadol; Pregabalin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind trial. Study drugs were prepared and dispensed in identical oral formulations by personnel not involved in patient care or outcome assessment. Neither patients nor the treating anaesthesiologist nor the outcome assessor knew group assignment throughout the study period.
• Purpose: PREVENTION
• 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: Two-arm parallel-group pilot RCT. Participants were randomised equally (n=23 per group) to receive 72-hour oral premedication with tapentadol (50 mg q12h) or pregabalin (75 mg q24h).

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: June 19, 2024
• Primary Completion: July 3, 2024
• Study Completion: July 5, 2024
• Last Updated: May 15, 2026

Record last verified: 2026-05

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)