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

Launched by NORTHWELL HEALTH · Apr 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how certain pain relief medications given before surgery can affect how quickly patients can urinate after undergoing minor urogynecologic surgeries. The researchers want to see if using a combination of three medications—acetaminophen, celecoxib, and gabapentin—before surgery helps patients get back to normal faster compared to just taking acetaminophen alone. The surgeries involved are typically performed on the same day and include procedures like midurethral sling placements and bladder injections.

To participate in the trial, you need to be a female patient over 18 years old who is in good health and able to take oral medications. You also need to be willing to follow the study rules and provide consent. This study is being conducted in certain locations in New York, and participants can speak either English or Spanish. If you join, you can expect to receive medication before your surgery and be monitored afterward to see how quickly you are able to urinate. It's important to note that certain health conditions and current medications may prevent someone from participating, so discussing your health history with the research team is essential.

Gender

FEMALE

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