Recruiting
Phase 1

Acetaminophen, NSAIDs, Opioids

Sponsor:

Columbia University

Code:

NCT07824258

Conditions

Vasectomy

NSAIDs

Post-operative Care

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

ibuprofen

oxycodone

Study Details

Brief 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.

Conditions

Vasectomy

NSAIDs

Post-operative Care

Study ID

NCT07824258

Start date

Sep 10, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- Consent for vasectomy

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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.

ibuprofen

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

oxycodone

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

Primary outcome measure

  • Brief Pain Inventory (BPI) - Total Score [ Time Frame: 1 to 7 days post operatively ]

Central Contacts and Locations

Central contacts

Aaron Brant, MD

212-305-0114menshealth@cumc.columbia.edu

Locations

Columbia University Medical Center/ New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Aaron Brant, MD

212-305-0114menshealth@cumc.columbia.edu

Principal Investigator:

Aaron M Brant, MD

New York-Presbyterian The One

Recruiting

White Plains, New York, United States, 10604

Contacts

Aaron Brant, MD

212-305-0114menshealth@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • vasectomy
  • NSAIDs
  • Post-operative care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Columbia University on 2026-09-17.