NCT03859024

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Pain, Postoperative
• Urethral Stricture

Interventions

Type	Name	Description
DRUG	Oxycodone	oxycodone tablet
DRUG	Acetaminophen	acetaminophen tablet
DRUG	Gabapentin	gabapentin tablet
DRUG	celebrex	Celebrex tablet
DRUG	Bupivacaine	bupivacaine injection
DRUG	Ibuprofen 800 mg	ibuprofen tablet
DRUG	Dexamethasone	Dexamethasone injection

Timeline

• Start date: 2019-03-22
• Primary completion: 2023-04-30
• Completion: 2023-06-30
• First posted: 2019-03-01
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study