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

NCT05609682 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 15207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Examine the efficacy of gabapentin in changing postoperative pain scores

  Measured using the validated surgical pain scale in which 0 (minimum value) means no pain sensation and 10 (maximum value) means most intense pain imaginable

  2 weeks post-op

Secondary Outcomes (3)

• Post-operative opioid consumption

  2 weeks post-op

• Patient satisfaction

  2 weeks post-op

• Degree of somnolence

  2 weeks post-op

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Standard ERAS protocol post-operative care with placebo

Drug: Placebo

Gabapentin Arm

ACTIVE COMPARATOR

Standard ERAS protocol with scheduled postoperative gabapentin

Drug: Gabapentin

Interventions

Gabapentin DRUG

Scheduled gabapentin given for two weeks after surgery

Gabapentin Arm

Placebo DRUG

Placebo given for two weeks after surgery

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Lieschen Quiroz, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled pilot trial. Randomization will be computer generated, using a 1:1 allocation and variable block sizes of 2 and 4.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: November 8, 2022
• Study Start: November 29, 2022
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)