Clinical trial · Interventional
Postoperative Analgesic Consumption After Preoperative Gabapentin vs Placebo in Breast Cancer Surgery
Comparison of Mean Analgesia Consumption for Postoperative Pain With Single Dose of Preoperative Oral Gabapentin Versus Placebo in Patients Undergoing Breast Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Surgery Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Gabapentin pre-op | Drug | — | UNRESOLVED |
| Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Patients in Group A were given oral Gabapentin 600 mg preoperatively.
- interventionNames
- Drug: Oral Gabapentin pre-op
- type
- PLACEBO_COMPARATOR
- label
- Group B
- description
- Patients in Group B were given Oral Vitamins B tablets perioperativey
- interventionNames
- Drug: Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)
Primary outcomes (1)
- measure
- To compare post-operative mean morphine consumption between Single Dose of Preoperative Oral Gabapentin versus Placebo in Patients Undergoing Breast Surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 to 60 years. 2. Female Gender 3. American Society of Anesthesiologists grade 1 and 2 patients. 4. Elective breast surgery 5. Admitted and day case surgeries Exclusion Criteria: 1. Patients allergic to gabapentin 2. Patients refusal. 3. Patients having a history of chronic pain. 4. Patients already using opioids for pain control
References
Publications (1)
- RESULTModak 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