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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859024
• Other study ID #: IRB-300002992
• Status: Completed
• Phase: Phase 4
• Start date: March 22, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Urethral Stricture

Intervention

Drug:
• Oxycodone
oxycodone tablet
• Acetaminophen
acetaminophen tablet
• Gabapentin
gabapentin tablet
• celebrex
Celebrex tablet
• Bupivacaine
bupivacaine injection
• Ibuprofen 800 mg
ibuprofen tablet
• Dexamethasone
Dexamethasone injection

Locations

Country	Name	City	State
United States	University of Alabama of Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 weeks
Primary	Opioid medication use	Amount of opioid medication used, based on return pill count at postoperative visit.	3 weeks