Post-Vasectomy Pain RCT

September 11, 2026 updated by: Aaron Brant, Columbia University

A Randomized Controlled Trial of Post-vasectomy Pain Management

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/ New York Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Aaron M Brant, MD
      • White Plains, New York, United States, 10604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Consent for vasectomy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetaminophen only
Participants are encouraged to take only acetaminophen 975 mg every 6 hours for the first 48 hours to a maximum of 7 days after surgery.
Drug: Acetaminophen
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
Experimental: Acetaminophen + ibuprofen
Participants are encouraged to take acetaminophen 975 mg and ibuprofen 600 mg every 6 hours for the first 48 hours to a maximum 7 days after surgery.
Drug: Acetaminophen
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
Drug: ibuprofen
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.
Other Names:
  • Motrin
Experimental: Acetaminophen + oxycodone
Participants are encouraged to take acetaminophen 975 mg every 6 hours for the first 48 hours to a maximum of 7 days after surgery, and a prescription for 6 tablets of oxycodone 5 mg will be prescribed to take every 6 hours as needed for pain.
Drug: Acetaminophen
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
Drug: oxycodone
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
Experimental: Acetaminophen + ibuprofen + oxycodone
Participants are encouraged to take acetaminophen 976 mg and ibuprofen 600 mg every 6 hours for the first 48 hours to a maximum of 7 days after surgery, and a prescription for 6 tablets of oxycodone 5 mg will be prescribed to take every 6 hours as needed for pain.
Drug: Acetaminophen
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
Drug: ibuprofen
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.
Other Names:
  • Motrin
Drug: oxycodone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 to 7 days post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 to 7 days post operatively
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.
1 to 7 days post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Aaron Brant, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACYY1239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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