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

NCT07804784 | Completed

• 1 other identifier: IRB-24-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gabapentin; Breast neoplasm; pain; postoperative; analgesics; opoid; morphine

Outcome Measures

Primary Outcomes (1)

• To compare post-operative mean morphine consumption between Single Dose of Preoperative Oral Gabapentin versus Placebo in Patients Undergoing Breast Surgery

  This study aims to compare postoperative morphine consumption in patients undergoing breast surgery who receive a single preoperative dose of oral gabapentin versus placebo. The primary outcome will be the total amount of morphine required during the postoperative recovery period. The study will determine whether preoperative gabapentin reduces postoperative opioid requirements and improves pain management.

  2 hours post surgery

Study Arms (2)

Group A

EXPERIMENTAL

Patients in Group A were given oral Gabapentin 600 mg preoperatively.

Drug: Oral Gabapentin pre-op

Group B

PLACEBO COMPARATOR

Patients in Group B were given Oral Vitamins B tablets perioperativey

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

Interventions

Oral Gabapentin pre-op DRUG

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

Group A

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

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

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Females having Breast Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 to 60 years.
• Female Gender
• American Society of Anesthesiologists grade 1 and 2 patients.
• Elective breast surgery
• Admitted and day case surgeries

You may not qualify if:

• Patients allergic to gabapentin
• Patients refusal.
• Patients having a history of chronic pain.
• Patients already using opioids for pain control

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre: lead

Study Sites (1)

Shaukat Khanum Memorial Cancer Hospital and Research Centre

Lahore, Punjab Province, 5400, Pakistan

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Vitamin B Complex

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial. STUDY SETTING: Hospital: Shaukat khanum Memorial hospital Lahore Department: Anesthesia department DURATION: 6 months after approval of synopsis. SAMPLE SIZE: The sample size is calculated by using an open epi WHO sample size calculator. Taking relevant statistics from previous study10 for the gabapentin group as post-operative mean morphine consumption 11.0 mg and standard deviation (SD) 2.0 mg and for placebo mean morphine consumption 13.1 mg and standard deviation (SD) 2.25 mg10. Power of study 95 %, 95 % Confidence interval (CI) and assuming 10% drop-out rate. The calculated sample size came out as 30 patients in each group. The total sample size would be 60 patients.

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 4, 2026
• Study Start: January 1, 2026
• Primary Completion: May 30, 2026
• Study Completion: June 30, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)