Post-Vasectomy Pain Study
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
Interventions
Acetaminophen
ibuprofen
oxycodone
Conditions
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