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

Primary Purpose

Pain, Postoperative, Urethral Stricture

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Acetaminophen
Gabapentin
celebrex
Bupivacaine
Ibuprofen 800 mg
Dexamethasone
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring anterior urethroplasty, pain management, postoperative pain, opioid use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama of Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Protocol

Enhanced Recovery Protocol

Arm Description

Patients will receive the historical standard for pain management, which may include narcotics during and after surgery. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed.

A combination regimen of acetaminophen, Celebrex and gabapentin pre-op, with 30 mL of 0.5% bupivacaine and 4 mg of dexamethasone given as a perineal nerve block at the time of urethroplasty surgery. Narcotics will be administered judiciously and ass seen fit by the anesthesia and/or surgical teams. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 27, 2019
Last Updated
July 30, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03859024
Brief Title
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
Official Title
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Urethral Stricture
Keywords
anterior urethroplasty, pain management, postoperative pain, opioid use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Protocol
Arm Type
Active Comparator
Arm Description
Patients will receive the historical standard for pain management, which may include narcotics during and after surgery. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed.
Arm Title
Enhanced Recovery Protocol
Arm Type
Experimental
Arm Description
A combination regimen of acetaminophen, Celebrex and gabapentin pre-op, with 30 mL of 0.5% bupivacaine and 4 mg of dexamethasone given as a perineal nerve block at the time of urethroplasty surgery. Narcotics will be administered judiciously and ass seen fit by the anesthesia and/or surgical teams. Postoperative prescriptions ibuprofen 800 mg, and acetaminophen 1000 mg to be taken on a scheduled basis then as needed. Another prescription for oxycodone will be given to be used only if needed.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
oxycontin
Intervention Description
oxycodone tablet
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
tylenol
Intervention Description
acetaminophen tablet
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
neurontin
Intervention Description
gabapentin tablet
Intervention Type
Drug
Intervention Name(s)
celebrex
Other Intervention Name(s)
celecoxib
Intervention Description
Celebrex tablet
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
marcaine, exparel
Intervention Description
bupivacaine injection
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 800 mg
Other Intervention Name(s)
advil, motrin
Intervention Description
ibuprofen tablet
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
decadron, ozurdex
Intervention Description
Dexamethasone injection
Primary Outcome Measure Information:
Title
Participant pain control: Numerical Rating Scale (NRS)
Description
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
Title
Opioid medication use
Description
Amount of opioid medication used, based on return pill count at postoperative visit.
Time Frame
3 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Selph, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama of Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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