Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries

Pain, Postoperative Clinical Trial

Official title:

Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379425
• Other study ID #: 23-0050
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2024
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative

Intervention

Drug:
• Acetaminophen
Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
• Celecoxib
Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
• Gabapentin
Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery

Locations

Country	Name	City	State
United States	Northwell Health South Shore Surgery Center	Bay Shore	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to initiation of active trial of void		through study completion, an average of 2 years