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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859024
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
John Patrick Selph, MD, University of Alabama at Birmingham

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).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Urethral Stricture Drug: Oxycodone Drug: Acetaminophen Drug: Gabapentin Drug: celebrex Drug: Bupivacaine Drug: Ibuprofen 800 mg Drug: Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Protocol
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.
Drug: Oxycodone
oxycodone tablet
Other Name: oxycontin

Drug: Acetaminophen
acetaminophen tablet
Other Name: tylenol

Drug: Ibuprofen 800 mg
ibuprofen tablet
Other Name: advil, motrin

Experimental: Enhanced Recovery Protocol
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.
Drug: Oxycodone
oxycodone tablet
Other Name: oxycontin

Drug: Acetaminophen
acetaminophen tablet
Other Name: tylenol

Drug: Gabapentin
gabapentin tablet
Other Name: neurontin

Drug: celebrex
Celebrex tablet
Other Name: celecoxib

Drug: Bupivacaine
bupivacaine injection
Other Name: marcaine, exparel

Drug: Ibuprofen 800 mg
ibuprofen tablet
Other Name: advil, motrin

Drug: Dexamethasone
Dexamethasone injection
Other Name: decadron, ozurdex




Primary Outcome Measures :
  1. Participant pain control: Numerical Rating Scale (NRS) [ Time Frame: 3 weeks ]
    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

  2. Opioid medication use [ Time Frame: 3 weeks ]
    Amount of opioid medication used, based on return pill count at postoperative visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859024


Contacts
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Contact: Dorothy Butler 205-975-0277 dybutler@uabmc.edu

Locations
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United States, Alabama
University of Alabama of Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Dorothy Butler    205-975-0277    dybutler@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: John P Selph, MD University of Alabama at Birmingham
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Responsible Party: John Patrick Selph, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03859024    
Other Study ID Numbers: IRB-300002992
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Patrick Selph, MD, University of Alabama at Birmingham:
anterior urethroplasty
pain management
postoperative pain
opioid use
Additional relevant MeSH terms:
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Urethral Stricture
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Acetaminophen
Dexamethasone
Ibuprofen
Celecoxib
Oxycodone
Gabapentin
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants