drugset / Trial / NCT07804784

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

NCT07804784 ↗

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Publications

  • Results Modak SD, Magar J, Kakad V. Pre-emptive gabapentin for postoperative pain relief in abdominal hysterectomy. International Journal of Research in Medical Sciences 2016;4(9):3755-9

Drugs

EvaluationDrugModalityDoseRoute
Subject Gabapentin Unknown 600 mg Oral

Indications