Effect of Gabapentin on Post-Operative Pain in Minimally Invasive Sacrocolpopexy

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Enhanced recovery after surgery (ERAS) has been synonymous with increasing non-opioid multimodal therapies and decreasing opioid therapies after surgery to improve perioperative care. Gabapentin has been standardized as part of routine adjuvant post-operative enhanced recovery protocols after other surgical specialties surgeries. Limited data is known about the specifics of routine adjuvant post-operative gabapentin in the realm of urogynecology. Sacrocolpopexy has been noted as a highly effective prolapse surgical treatment, especially with apical and multicompartment prolapse. In 2006, approximately 73% of all sacrocolpopexy across the nation are completed through a minimally invasive approach. The role of gabapentin as part of a postoperative pain protocol following minimally invasive sacrocolpopexy (MISC) has yet to be determined.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Gabapentin

Criteria

Inclusion Criteria:

• Patients have a diagnosis of uterovaginal prolapse, vaginal vault prolapse, or pelvic organ prolapse (based on International Classification of Diseases [ICD]).

Exclusion Criteria:

• Concurrent sphincter or fistula repair, urethral diverticulectomy or mesh excision

• Current gabapentin or pregabalin use

• Oxygen dependency

• Renal failure or glomerular filtration rate of < 30mL/min

• Daily narcotic usage >2 months - this is to allow us to capture an opiate-naïve patient population to better assess the impact of adjuvant gabapentin