RECRUITING

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

Conditions

Pain, Postoperative Postoperative Pain, Acute

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-01

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06379425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Locations (Sites)

Northwell Health South Shore Surgery Center

Bay Shore, New York, 11706

United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

Pain, Postoperative
Postoperative Pain, Acute