Phase 4
Completed N=48
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
Pain, Postoperative · Urethral Stricture
Source: ClinicalTrials.gov NCT03859024 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Participant Pain Control: Numerical Rating Scale (NRS) — 1.2; .625 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Pain Control: Numerical Rating Scale (NRS) |
1.2; .625 | — |
| PRIMARY Opioid Medication Use |
5.14; 4.96 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03859024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.