Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty

IRB-300002992

The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized to one of two pain regimens (enhanced recovery regimen vs standard regimen).

2019-03-22

2023-04-30

2023-06-30

Completed

Early phase I

60

Inclusion Criteria: * Men greater than 18 years of age who are scheduled for anterior urethroplasty surgery Exclusion Criteria: * Any patient not classified as a II or III on the American Society of Anesthesiologists (ASA) physical status classification system. * General anesthesia or neuraxial anesthesia with epidural used as anesthetic techniques * Allergy/intolerance to local anesthetic or steroids * Pre-existing neurological and/or anatomical deficit that would preclude regional block * Coexisting coagulopathy such as hemophilia or von Willebrand Disease * BMI greater than 40 or less then 20 * History of intravenous drug or opioid abuse * History of opioid use within a week prior to urethroplasty * History of any chronic pain syndrome * Posterior urethroplasty * Patients with chronic kidney disease * Patients allergic to NSAIDs * Patients requiring more than one buccal graft harvest * Patients with graft urethroplasty with site other than buccal * Patients with a history of previous urethroplasty

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-08-01