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

NCT03859024 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-300002992
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain, Postoperative; Urethral Stricture

Keywords

anterior urethroplasty; pain management; postoperative pain; opioid use

Outcome Measures

Primary Outcomes (2)

• 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

• Opioid Medication Use

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

  3 weeks

Study Arms (2)

Standard Protocol

ACTIVE COMPARATOR

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; Drug: Acetaminophen; Drug: Ibuprofen 800 mg

Enhanced Recovery Protocol

EXPERIMENTAL

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; Drug: Acetaminophen; Drug: Gabapentin; Drug: celebrex; Drug: Bupivacaine; Drug: Ibuprofen 800 mg; Drug: Dexamethasone

Interventions

Oxycodone DRUG

oxycodone tablet

Also known as: oxycontin

Enhanced Recovery Protocol; Standard Protocol

Acetaminophen DRUG

acetaminophen tablet

Also known as: tylenol

Enhanced Recovery Protocol; Standard Protocol

Gabapentin DRUG

gabapentin tablet

Also known as: neurontin

Enhanced Recovery Protocol

celebrex DRUG

Celebrex tablet

Also known as: celecoxib

Enhanced Recovery Protocol

Bupivacaine DRUG

bupivacaine injection

Also known as: marcaine, exparel

Enhanced Recovery Protocol

Ibuprofen 800 mg DRUG

ibuprofen tablet

Also known as: advil, motrin

Enhanced Recovery Protocol; Standard Protocol

Dexamethasone DRUG

Dexamethasone injection

Also known as: decadron, ozurdex

Enhanced Recovery Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men greater than 18 years of age who are scheduled for anterior urethroplasty surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama of Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Urethral Stricture; Agnosia

Interventions

Oxycodone; Acetaminophen; Gabapentin; Celecoxib; Bupivacaine; Ibuprofen; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Phenylpropionates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids

Results Point of Contact

• Title: Dr. Adam Baumgarten
• Organization: University of Alabama at Birmingham

abaumgarten@uabmc.edu

205-996-6769

Study Officials

• John P Selph, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: March 22, 2019
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)