Clinical trial NCT06379425: Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries
Official title: Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Postoperative Pain, Acute
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. All female patients over 18 years of age from the Northwell Health urogynecology offices in Bay Shore, Syosset, and Huntington, NY who are undergoing transvaginal minor urogynecologic surgery (midurethral sling, periurethral bulking injections, anterior repair, posterior repair, and perineorrhaphy) at South Shore Surgery Center
4. In good general health as evidenced by medical history
5. Ability to take oral medication and be willing to adhere to the study intervention
6. Patients may be English or Spanish-speaking and must be able to provide informed consent

Exclusion Criteria:

1. Pregnancy or lactation
2. Younger than age 18
3. Known allergic reactions to acetaminophen, celecoxib or gabapentin or any components within the medication formulation
4. Patients with Myasthenia Gravis, renal disease with CrCl \< 50, seizure disorder, substance use disorder, anaphylaxis and angioedema to gabapentin, Drug reaction with Eosinophilia and Systemic Symptoms (DRESS), driving impairment, increased seizures suicidal behavior and respiratory depression.
5. Patients with a , history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDS or DRESS, history of gastric bypass surgery, heart failure, active GI ulcer, active GI bleeding, inflammatory bowel disease, cerebrovascular bleeding, liver impairment/hepatic disease, hyperkalemia.
6. Patients with compromised renal function who are notable to receive NSAIDs
7. Patients with significant cardiovascular disease, such as patients with heart failure
8. Patient with recent evidence of worsening fluid retention
9. Both non-English and non-Spanish speaking patients
10. Urogynecologic surgeries for apical repair (sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament suspension, colpocleisis)
11. Current use of illicit substances (cocaine, non-prescription opioids, marijuana)
12. Current use of gabapentin as home medication

Primary outcomes:
measure: Time to initiation of active trial of void
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bay Shore
country: United States
facility: Northwell Health South Shore Surgery Center
state: New York
Study officials:
References: