Postoperative Analgesic Consumption After Preoperative Gabapentin vs Placebo in Breast Cancer Surgery

NCT07804784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-09-04

No results posted yet for this study

Summary

The study will be conducted after approval from the Scientific and Ethical Review Committees. Eligible patients will be enrolled after obtaining written informed consent and randomly allocated to Group A (gabapentin) or Group B (placebo). Group A will receive oral gabapentin 600 mg one hour before surgery, while Group B will receive oral placebo (sodium bicarbonate) at the same time.

General anesthesia will be induced with propofol, atracurium, and fentanyl and maintained with sevoflurane using a supraglottic airway device. Both groups will receive IV paracetamol, ketorolac, and local bupivacaine infiltration. Intraoperative rescue analgesia with IV morphine will be given if hemodynamic parameters increase by \>20% from baseline.

Postoperatively, patients will be monitored in the recovery area for pain using the Numeric Rating Scale (NRS) and for adverse effects including drowsiness, nausea, and vomiting. IV morphine 0.1 mg/kg will be administered if the NRS pain score is \>2. The total morphine consumption during recovery will be recorded for both groups. Data will be collected using the attached proforma.

Conditions

  • Breast Cancer Surgery Pain

Interventions

DRUG

Oral Gabapentin pre-op

A single perioperative 600 mg dose of oral Gabapentin significantly reduces intraoperative and postoperative morphine consumption.

DRUG

Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)

A single perioperative dose of oral Vitamin B complex tablet given as Placebo.

Sponsors & Collaborators

  • Shaukat Khanum Memorial Cancer Hospital & Research Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-05-30
Completion
2026-06-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804784 on ClinicalTrials.gov