Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama of Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
oxycodone tablet
Other Names:
acetaminophen tablet
Other Names:
ibuprofen tablet
Other Names:
|
|
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.
|
oxycodone tablet
Other Names:
acetaminophen tablet
Other Names:
gabapentin tablet
Other Names:
ibuprofen tablet
Other Names:
Celebrex tablet
Other Names:
bupivacaine injection
Other Names:
Dexamethasone injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 weeks
|
|
Opioid Medication Use
Time Frame: 3 weeks
|
Amount of opioid medication used, based on return pill count at postoperative visit.
|
3 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: John P Selph, MD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Urethral Diseases
- Urethral Obstruction
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Pain, Postoperative
- Urethral Stricture
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Anticonvulsants
- Anesthetics, Local
- Antimanic Agents
- Cyclooxygenase 2 Inhibitors
- Dexamethasone
- Gabapentin
- Celecoxib
- Acetaminophen
- Bupivacaine
- Ibuprofen
- Oxycodone
Other Study ID Numbers
- IRB-300002992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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