Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • oxycontin
  • Drug: Acetaminophen
    acetaminophen tablet
    Other names:
    • tylenol
  • Drug: Ibuprofen 800 mg
    ibuprofen tablet
    Other names:
    • 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 names:
    • oxycontin
  • Drug: Acetaminophen
    acetaminophen tablet
    Other names:
    • tylenol
  • Drug: Gabapentin
    gabapentin tablet
    Other names:
    • neurontin
  • Drug: celebrex
    Celebrex tablet
    Other names:
    • celecoxib
  • Drug: Bupivacaine
    bupivacaine injection
    Other names:
    • marcaine, exparel
  • Drug: Ibuprofen 800 mg
    ibuprofen tablet
    Other names:
    • advil, motrin
  • Drug: Dexamethasone
    Dexamethasone injection
    Other names:
    • decadron, ozurdex

Recruiting Locations

University of Alabama of Birmingham
Birmingham, Alabama 35233
Contact:
Dorothy Butler
205-975-0277
dybutler@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Dorothy Butler
205-975-0277
dybutler@uabmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.