Pain, Postoperative, Postoperative Pain, Acute
Conditions
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.
Interventions
DRUGAcetaminophen
Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
DRUGCelecoxib
Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
DRUGGabapentin
Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to initiation of active trial of void | through study completion, an average of 2 years |
Countries
United States
Outcome results
None listed