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
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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