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Recruiting NCT05609682

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

Conditions: Post Operative Pain

Sex: Female
Ages: 18 Years – 99 Years
Phase: EARLY_PHASE1
Enrollment: 40
Sponsor: University of Oklahoma

Location: United States

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.

Eligibility 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 excisionCurrent gabapentin or pregabalin useOxygen dependencyRenal failure or glomerular filtration rate of < 30mL/minDaily narcotic usage >2 months - this is to allow us to capture an opiate-naïve patient population to better assess the impact of adjuvant gabapentin

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05609682). StuddyBuddy aggregates publicly available trial information.