Skip to main content
Back to Trials
NCT07824258PHASE1Recruiting

Post-Vasectomy Pain Study

Columbia University

Start Date

9/10/2026

Completion Date

12/31/2035

Summary

This is a prospective four-armed unblinded randomized controlled trial to assess four different potential post-operative treatment options for men who undergo a vasectomy. The aims of this study are: * To determine whether the addition of nonsteroidal anti-inflammatory drugs (NSAIDs) to acetaminophen results in improved pain after vasectomy; * To determine whether the addition of opioid pain medication to acetaminophen and/or NSAIDs results in improved pain after vasectomy; * To determine whether the use of NSAIDs for post-operative pain management increases risk of hematoma after vasectomy.

Detailed Description

The purpose of this study is to evaluate and compare commonly used post-vasectomy pain regimens. Eligible participants will be adult male patients who elect to undergo vasectomy with a urologist at Columbia University Medical Center with no history of kidney or liver disease, chronic pain conditions, or drug abuse. Prospectively enrolled participants will be randomized to one of four study arms, which will differ by post-operative pain regimens as follows: * Arm 1: 975 mg acetaminophen every 6 hours for the first 48 hours to a maximum of 7 days; * Arm 2: 975 mg acetaminophen and 600 mg ibuprofen every 6 hours for the first 48 hours to a maximum of 7 days; * Arm 3: 975 mg acetaminophen every 6 hours for the first 48 hours to a maximum of 7 days with a prescription for 6 tablets of 5 mg oxycodone every 6 hours as needed; * Arm 4: 975 mg acetaminophen and 600 mg ibuprofen every 6 hours for the first 48 hours to a maximum of 7 days with a prescription for 6 tablets of 5 mg oxycodone every 6 hours as needed. Other than the differing pain regimens, all treatment and pre- and post-operative counselling will be standard of care at the discretion of the treating urologists. Participants will be contacted at 1 day and 7 days post-operatively to complete Brief Pain Inventory (BPI) questionnaires, assess how many tablets of oxycodone they have taken, and assess whether they would be comfortable returning to work. At post-operative visits, their treating urologist will assess them for the presence of hematoma. Comparisons will be made between study arms to assess for differences.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: \- Consent for vasectomy Exclusion Criteria: * History of kidney or liver disease * History of chronic pain condition * History of drug abuse

Interventions

DRUG

Acetaminophen

DRUG

ibuprofen

DRUG

oxycodone

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

VasectomyNSAIDsPost-operative Care

Locations

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York 10032

United States

New York-Presbyterian The One

White Plains, New York 10604

United States