Post-Vasectomy Pain RCT

Conditions

• NSAIDs
• Post-operative Care
• Vasectomy

Eligibility Criteria

Sex

MALE

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

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.
• ibuprofen — DRUG
  Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.
• oxycodone — DRUG
  Oxycodone is a potent semi-synthetic opioid analgesic used to treat moderate to severe pain when other treatments are insufficient

Study Details

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.

Key Dates

First listed

Sep 17, 2026

Start date

Sep 10, 2026

Status verified

Sep 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2035

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

• Aaron Brant, MD
  212-305-0114
  [email protected]

Locations (2)

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