The Effect of Preoperative Gabapentin on Postoperative Pain Control and Analgesic Requirements Following Bariatric Surgery

NCT07169006 | Not Yet Recruiting DMC

• 1 other identifier: MD326/2024
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

The importance of bariatric anesthesia and analgesia research cannot be ignored as it can inform and improve the perioperative protocols for other patients with morbid obesity irrespective of the surgical procedures they are undergoing

Conditions

Bariatric Surgery Analgesia

Outcome Measures

Primary Outcomes (1)

• Comparing pain score between the two groups during 1st postoperative 24 hours using visual analogue score (VAS

  Comparing pain score between the two groups during 1st postoperative 24 hours using visual analogue score (VAS

  24 hours postoperative

Study Arms (2)

Group 1

EXPERIMENTAL

Will receive a single dose of gabapentin 300 mg preoperatively before standard general anesthesia

Drug: Group 1

Group 2

PLACEBO COMPARATOR

will receive a placebo before standard general anesthesia

Drug: Group 2

Interventions

Group 1 DRUG

Will receive a single dose of gabapentin 300 mg preoperatively before standard general anesthesia

Also known as: Gabapentin 300

Group 1

Group 2 DRUG

will receive a placebo before standard general anesthesia

Also known as: Placebo

Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with American Society of Anesthesiologists physical status ASA I to III
• both genders
• Morbid obese scheduled for bariatric surgery

You may not qualify if:

• patients with impaired liver or kidney disease
• patients with history of hypersensitivity to gabapentin
• patients with history of alcohol abuse, chronic pain or frequent use of analgesic
• patients with uncontrolled medical disease

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Assuming an effect size of 0.5 for preoperative gabapentin, a sample of 51 patients in each group would be enough to detect such effect, if true, at 0.05 alpha error and 0.80 power of the test

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-01