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NCT Number: NCT07804784

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shaukat Khanum Memorial Cancer Hospital and Research Centre

Lahore, Punjab Province, 5400, Pakistan

About this study

This study will be carried out after approval from scientific and ethical review committee. Patient who fulfill the criteria will be enrolled in this study. Written and informed consent will be taken from study participants. Patients will be randomly allocated (as mentioned above) either in to group A (Gabapentin) or group B (placebo). Patients in Group A will be given oral gabapentin 600 mg10 one hour before surgery while patients in group B will be given oral placebo (Tablet sodium bicarbonate) one hour before surgery. . Induction of anesthesia will be done using propofol 1.5-2 mg/kg, atracurium 0.5 mg/kg and fentanyl 1 mcg/kg. Both group of patients will undergo general anesthesia with supra glottic airway device. Anesthesia will be maintained using sevoflurane using MAC 0.8-1.0. Both group of patients will receive intravenous paracetamol 1 gram, ketorolac 30 mg and local infiltration (bupivacaine) upto 2mg/kg. Intravenous morphine (0.1 mg/kg) will be administered intra operatively as rescue analgesia if blood pressure or/and heart rate increases 20 % above baseline. Ondansetron IV, 4 mg, was administered 30 minutes before to the conclusion of operation. After surgery patients will be transferred to recovery area. Patients will be monitored for pain score for a period of their whole stay in recovery area using numeric rating scale. The post-anesthesia care unit was transferred with the patients. In recovery area, adverse effects such pain, drowsiness, nausea, vomiting, and others were monitored. If the pain is score is greater than 2, then intra venous morphine 0.1 mg/kg will be administered as a bolus. Therefore in both group of patients total morphine used for each patient during their stay in recovery will be noted. Data will be collected on Performa attached at the end.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Oral Gabapentin pre-op

Drug

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

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

Drug

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

Primary outcomes

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

    Time frame: 2 hours post 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.

Sponsors and collaborators

Lead sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Other

Registry information

Official study title

Comparison of Mean Analgesia Consumption for Postoperative Pain With Single Dose of Preoperative Oral Gabapentin Versus Placebo in Patients Undergoing Breast Cancer Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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