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

University of Alabama at Birmingham48 enrolled

Overview

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).

The purpose of this study is to assess the difference in narcotics usage between two different pain management protocols after urethroplasty. Management at the current time varies between giving intraoperative painkillers along with peripheral nerve blocks in some patients, while others do not receive this protocol. In this study, one group will continue the historical standard of care of the hospital, receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics for pain control. The other group will utilize a protocol to lower narcotics usage, including acetaminophen, gabapentin, Celebrex, and local anesthetic (bupivacaine) in an attempt to reduce the usage of narcotics postoperatively. Given the heightened concern over narcotic usage by postoperative patients, including the risk of chronic usage by even young patients, the objective will be to assess if using this protocol as a new standard can limit the need for postoperative narcotics prescriptions. In related urological procedures, bupivacaine injections given before surgeries have been shown to significantly lower pain scores after surgery for patients undergoing penile prosthesis. The University of Alabama at Birmingham has also been using an Enhanced Recovery After Surgery (ERAS) protocol, a multimodal presurgical care pathway designed to achieve early recovery after surgical procedures, for cystectomy and seen reduced narcotic usage among those patients. This study would potentially help determine a new pain management protocol for urology patients undergoing anterior urethroplasty that is both more effective and less risky.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain, Postoperative Urethral Stricture

Interventions

OxycodoneDRUG

oxycodone tablet

AcetaminophenDRUG

acetaminophen tablet

GabapentinDRUG

gabapentin tablet

celebrex

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama of Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Participant Pain Control: Numerical Rating Scale (NRS)

Self-report via pain score on the Numerical Rating Scale (NRS) for pain, an 11-point scale for patient self-reporting of pain. A rating of 0 equates to no pain, 1-3 equates to mild pain, 4-6 equates to moderate pain, and 7-10 equates to severe pain. Assessment will occur at clinic visit, at pre-op visit, in pre-op holding before surgery, per anesthesia protocol after surgery in recovery and discharge unit, and at postoperative visit

Time frame: 3 weeks

Opioid Medication Use

Amount of opioid medication used, based on return pill count at postoperative visit.

Time frame: 3 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.