Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Launched by JOSEPH KOWALSKI · Dec 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of gabapentin, a medication often used for pain relief, on women who are about to undergo surgery for pelvic organ prolapse. In this study, women scheduled for vaginal apical suspension surgery will be randomly assigned to receive either gabapentin or a placebo (a substance with no active medication) before their surgery. The main goal is to see if taking gabapentin before the surgery can reduce the amount of opioid pain medication needed in the first 24 hours after the operation.

To participate, women must be at least 18 years old and scheduled for specific types of vaginal surgery for pelvic support. However, those who are non-English speakers, have cognitive impairments, or are chronic users of opioids or gabapentinoids will not be eligible. Participants will receive standard pain relief medications, including acetaminophen and celecoxib, along with either gabapentin or placebo. Throughout the trial, both the patients and the researchers will not know who is receiving which treatment, ensuring a fair comparison. This study is currently recruiting participants, aiming to improve pain management after surgery for pelvic organ prolapse.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Scheduled for a vaginal apical support procedure (sacrospinous ligament fixation or vaginal uterosacral ligament suspension)
• • Female
• • Age 18 or higher
• Exclusion Criteria:
• • Non-English speaking
• • Incarcerated
• • Cognitive impairment precluding informed consent
• • Chronic opioid user
• • Chronic gabapentinoid user
• • Contraindication to acetaminophen, celecoxib, or gabapentinoids
• • Concurrent laparoscopic or abdominal surgery

Trial Officials