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

  • STATUS
    Recruiting
  • End date
    Apr 16, 2023
  • participants needed
    60
  • sponsor
    University of Alabama at Birmingham
Updated on 7 February 2022
analgesia
bupivacaine
opioid
oxycodone
ibuprofen
dexamethasone
gabapentin
ibuprofen 800 mg
urethroplasty
acetaminophen

Summary

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).

Description

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.

Details
Condition Pain, Postoperative, Urethral Stricture
Treatment Dexamethasone, Gabapentin, Celebrex, Acetaminophen, Oxycodone, Bupivacaine, Ibuprofen 800 mg
Clinical Study IdentifierNCT03859024
SponsorUniversity of Alabama at Birmingham
Last Modified on7 February 2022

Eligibility

Yes No Not Sure

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
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