VasectomyPhase 1NCT07824258
Post-Vasectomy Pain Study
A Phase 1 study testing Acetaminophen, ibuprofen and oxycodone in people with Vasectomy and NSAIDs, run by Columbia University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Vasectomy, NSAIDs, Post-operative Care
- What is being tested?
- Acetaminophen, ibuprofen and oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2026to 31 Dec 2035
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent for vasectomy
Who cannot join
- History of kidney or liver disease
- History of chronic pain condition
- History of drug abuse
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, 10032
Aaron Brant, MD, 212-305-0114, menshealth@cumc.columbia.edu
Aaron M Brant, MD
- Recruiting
New York-Presbyterian The One
White Plains, New York, 10604
Aaron Brant, MD, 212-305-0114, menshealth@cumc.columbia.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Vasectomy, NSAIDs, Post-operative Care
- Being tested
- Acetaminophen, ibuprofen, oxycodone
- Keywords
- vasectomy, NSAIDs, Post-operative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called paracetamol, APAP
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.
ibuprofenDrug
Also called Motrin
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.
oxycodoneDrug
Also called Oxycodone Hydrochloride Capsules
Oxycodone is a potent semi-synthetic opioid analgesic used to treat moderate to severe pain when other treatments are insufficient
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Acetaminophen; Drug: ibuprofen; Drug: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 to 7 days post operatively
Secondary outcomes (2)
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.
Measured: 1 to 7 days post operatively
Brief Pain Inventory (BPI) - Pain Severity Score
The Pain Severity Score ranges from 0 to 10, where a higher score indicates greater severity.
Measured: 1 to 7 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start10 Sep 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasectomyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Brant, Columbia University
- Investigators
- Aaron Brant, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824258
- Sponsor's protocol ID
- ACYY1239
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Post-vasectomy Pain Management
- ClinicalTrials.gov ID
- NCT07824258
- Acronym / sponsor ID
- ACYY1239
- Conditions
- Vasectomy, NSAIDs, Post-operative Care
- Keywords
- vasectomy, NSAIDs, Post-operative care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen only | Experimental | Drug: AcetaminophenParticipants are encouraged to take only acetaminophen 975 mg every 6 hours for the first 48 hours to a maximum of 7 days after surgery. |
| Acetaminophen + ibuprofen | Experimental | Drug: Acetaminophen, Drug: ibuprofenParticipants 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. |
| Acetaminophen + oxycodone | Experimental | Drug: Acetaminophen, Drug: oxycodoneParticipants 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. |
| Acetaminophen + ibuprofen + oxycodone | Experimental | Drug: Acetaminophen, Drug: ibuprofen, Drug: oxycodoneParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consent for vasectomy
Key exclusion criteria (3 listed)
- History of kidney or liver disease
- History of chronic pain condition
- History of drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: paracetamol, APAPAcetaminophen 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. | Drug | Acetaminophen + ibuprofen, Acetaminophen + ibuprofen + oxycodone, Acetaminophen + oxycodone, Acetaminophen only |
| ibuprofenAlso: MotrinIbuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation. | Drug | Acetaminophen + ibuprofen, Acetaminophen + ibuprofen + oxycodone |
| oxycodoneAlso: Oxycodone Hydrochloride CapsulesOxycodone is a potent semi-synthetic opioid analgesic used to treat moderate to severe pain when other treatments are insufficient | Drug | Acetaminophen + ibuprofen + oxycodone, Acetaminophen + oxycodone |
Primary outcome
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.
2 secondary outcomes
Brief Pain Inventory (BPI) - Pain Interference Score
Time frame: 1 to 7 days post operatively
Brief Pain Inventory (BPI) - Pain Severity Score
Time frame: 1 to 7 days post operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Brant, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acetaminophen, ibuprofen and oxycodone in people with Vasectomy and NSAIDs, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Brant, MD (212-305-0114, menshealth@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) - Total Score (time frame: 1 to 7 days post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.