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



Status:Not yet recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:April 2019
End Date:April 2021
Contact:Dorothy Butler
Email:dybutler@uabmc.edu
Phone:205-975-0277

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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.

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
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-975-0277
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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mi
from
Birmingham, AL
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