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NCT Number: NCT07824258

Post-Vasectomy Pain RCT

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Columbia University Medical Center/ New York Presbyterian Hospital, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent for vasectomy

Exclusion criteria

  • History of kidney or liver disease
  • History of chronic pain condition
  • History of drug abuse

Treatment and study plan

Acetaminophen

Drug

Acetaminophen is a widely used, over-the-counter medication that relieves mild to moderate pain and reduces fever. Unlike NSAIDs like ibuprofen, it does not treat inflammation or swelling.

Other names: paracetamol, APAP

Ibuprofen

Drug

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.

Other names: Motrin

Oxycodone

Drug

Oxycodone is a potent semi-synthetic opioid analgesic used to treat moderate to severe pain when other treatments are insufficient

Other names: Oxycodone Hydrochloride Capsules

Primary outcomes

  1. Brief Pain Inventory (BPI) - Total Score

    Time frame: 1 to 7 days post operatively

    The Brief Pain Inventory is a self-reported questionnaire to assess pain. Final scores will be averaged. The score range is 0 to 10, where a higher score indicates a worse outcome.

Secondary outcomes

  1. Brief Pain Inventory (BPI) - Pain Interference Score

    Time frame: 1 to 7 days post operatively

    The Pain Interference Score ranges from 0 to 10, where a higher score indicates greater interference with daily life.

  2. Brief Pain Inventory (BPI) - Pain Severity Score

    Time frame: 1 to 7 days post operatively

    The Pain Severity Score ranges from 0 to 10, where a higher score indicates greater severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron Brant, MD

CONTACT

[email protected]

212-305-0114

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

A Randomized Controlled Trial of Post-vasectomy Pain Management

Important dates

Study start
2026
Primary completion
2030
Study completion
2035
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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