Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorNorthwell Health
About this trial
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
This trial accepts healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
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
In good general health as evidenced by medical history
Disqualifiers
Pregnancy or lactation
Younger than age 18
Known allergic reactions to acetaminophen, celecoxib or gabapentin or any components within the medication formulation
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Acetaminophen
DrugWill add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
Celecoxib
DrugWill add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
Gabapentin
DrugWill add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Standard of Care (SOC) (acetaminophen)Active comparator 1 intervention
Group B: Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Time to initiation of active trial of void
Time frame
through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov