Post-Vasectomy Pain Study

NCT07824258 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ACYY1239
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

NSAIDs; Post-operative Care; Vasectomy

Keywords

vasectomy; NSAIDs; Post-operative care

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) - Total Score

  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 Outcomes (2)

• Brief Pain Inventory (BPI) - Pain Interference Score

  1 to 7 days post operatively

• Brief Pain Inventory (BPI) - Pain Severity Score

  1 to 7 days post operatively

Study Arms (4)

Acetaminophen only

EXPERIMENTAL

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 + ibuprofen

EXPERIMENTAL

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; Drug: ibuprofen

Acetaminophen + oxycodone

EXPERIMENTAL

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; Drug: oxycodone

Acetaminophen + ibuprofen + oxycodone

EXPERIMENTAL

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; Drug: ibuprofen; Drug: oxycodone

Interventions

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.

Also known as: paracetamol, APAP

Acetaminophen + ibuprofen; Acetaminophen + ibuprofen + oxycodone; Acetaminophen + oxycodone; Acetaminophen only

ibuprofen DRUG

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

Also known as: Motrin

Acetaminophen + ibuprofen; Acetaminophen + ibuprofen + oxycodone

oxycodone DRUG

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

Also known as: Oxycodone Hydrochloride Capsules

Acetaminophen + ibuprofen + oxycodone; Acetaminophen + oxycodone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Must have been born male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Consent for vasectomy

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (2)

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

New York-Presbyterian The One

White Plains, New York, 10604, United States

RECRUITING

MeSH Terms

Interventions

Acetaminophen; Ibuprofen; Oxycodone

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Aaron Brant, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Brant, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Model Details: The purpose of this study is to randomize patients undergoing vasectomy to four different potential post-operative treatment options: acetaminophen alone; acetaminophen and ibuprofen; acetaminophen with a prescription for oxycodone if needed; acetaminophen and ibuprofen with a prescription for oxycodone if needed. Patients will complete post-operative surveys to rate their pain after the procedure, to observe their use of opioids, and to assess for post-operative bleeding complications.

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 17, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

US (2)