Health TrialsbyHealthPanel

Post-Vasectomy Pain Study

ConditionsVasectomyNSAIDsPost-operative Care
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-65
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

History of kidney or liver disease

History of chronic pain condition

History of drug abuse

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Acetaminophen onlyExperimental treatment 1 intervention
Group B: Acetaminophen + ibuprofenExperimental treatment 2 interventions
Group C: Acetaminophen + oxycodoneExperimental treatment 2 interventions
Group D: Acetaminophen + ibuprofen + oxycodoneExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
1 to 7 days post operatively

Secondary outcomes

1

Brief Pain Inventory (BPI) - Pain Interference Score

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

Time frame
1 to 7 days post operatively
2

Brief Pain Inventory (BPI) - Pain Severity Score

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

Time frame
1 to 7 days post operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Source ClinicalTrials.gov
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