Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
NCT ID: NCT03859024
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2019-03-22
2023-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Oxycodone
oxycodone tablet
Acetaminophen
acetaminophen tablet
Ibuprofen 800 mg
ibuprofen tablet
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.
Oxycodone
oxycodone tablet
Acetaminophen
acetaminophen tablet
Gabapentin
gabapentin tablet
celebrex
Celebrex tablet
Bupivacaine
bupivacaine injection
Ibuprofen 800 mg
ibuprofen tablet
Dexamethasone
Dexamethasone injection
Interventions
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Oxycodone
oxycodone tablet
Acetaminophen
acetaminophen tablet
Gabapentin
gabapentin tablet
celebrex
Celebrex tablet
Bupivacaine
bupivacaine injection
Ibuprofen 800 mg
ibuprofen tablet
Dexamethasone
Dexamethasone injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Adam Baumgarten
Principal Investigator
Principal Investigators
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John P Selph, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama of Birmingham
Birmingham, Alabama, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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IRB-300002992
Identifier Type: -
Identifier Source: org_study_id
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