200 Participants NeededMy employer runs this trial

Pain Management for Post-Vasectomy Pain

Recruiting at 1 trial location
AB
Overseen ByAaron Brant, MD
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different pain medications work after a vasectomy, a procedure for male sterilization. It compares four pain management options: acetaminophen alone, acetaminophen with ibuprofen, acetaminophen with oxycodone (an opioid pain medication), and all three combined. The goal is to determine which combination most effectively alleviates pain and to assess whether ibuprofen might cause any bleeding issues post-surgery. Men who have agreed to a vasectomy and do not have kidney or liver disease, chronic pain conditions, or a history of drug abuse may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage medical research.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that combining acetaminophen and ibuprofen for pain relief was generally safe and effective. Research shows that these medications together can relieve pain well and reduce the need for stronger drugs like opioids. Acetaminophen is widely used and considered very safe when taken in the right amounts. Ibuprofen is effective but may cause stomach issues or bleeding, especially if used in high doses or for a long time.

For the acetaminophen and oxycodone combination, studies suggest it can effectively manage pain. However, oxycodone, an opioid, can cause side effects like drowsiness, constipation, and, more seriously, addiction. Careful use is important to avoid these problems.

When using all three—acetaminophen, ibuprofen, and oxycodone—together, studies indicate this combination can be very effective for pain control. However, awareness of the side effects of oxycodone and ibuprofen, such as addiction risks and stomach issues, is crucial.

Each option has its benefits and considerations. Following dosage guidelines is essential to ensure safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these pain management treatments for post-vasectomy pain because they explore different combinations of pain relievers that might offer better relief with fewer side effects. Standard care typically involves over-the-counter painkillers like acetaminophen or ibuprofen. The trial investigates combinations of these, and also includes oxycodone, a prescription opioid, to see if adding it provides superior pain control. By testing various combinations, the researchers aim to find an optimal balance between effective pain management and minimizing opioid use, which could lead to improved patient outcomes and satisfaction.

What evidence suggests that this trial's treatments could be effective for post-vasectomy pain management?

This trial will evaluate various pain management strategies for post-vasectomy pain. Participants will be assigned to one of several treatment arms. Research has shown that acetaminophen can relieve mild to moderate pain, such as headaches and muscle aches. One arm will involve acetaminophen only. Another will test acetaminophen with ibuprofen, a pain reliever that also reduces swelling; studies suggest this combination can enhance pain relief without significantly increasing side effects. A separate arm will evaluate acetaminophen combined with oxycodone, a stronger painkiller that may provide more relief but could cause side effects like drowsiness or nausea. Finally, one arm will test the combination of all three—acetaminophen, ibuprofen, and oxycodone—which can offer strong pain relief, though the benefits and potential side effects must be considered. These combinations work in different ways to manage pain more effectively.678910

Who Is on the Research Team?

AB

Aaron Brant, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adult men who are having a vasectomy. Participants should not have any medical reasons that would prevent them from safely taking ibuprofen, acetaminophen, or oxycodone.

Inclusion Criteria

Consent for vasectomy

Exclusion Criteria

History of drug abuse
I have a history of chronic pain.
I have a history of kidney or liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive one of four post-operative pain regimens for up to 7 days after vasectomy

1 week
2 visits (virtual)

Follow-up

Participants are monitored for pain management effectiveness and safety, including assessment for hematoma

1 week
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Acetaminophen
  • Ibuprofen
  • Oxycodone

Trial Overview

The study compares four different pain relief options after vasectomy: acetaminophen alone, acetaminophen with ibuprofen (an NSAID), and combinations including oxycodone (an opioid). Patients are randomly assigned to one of these groups.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Acetaminophen onlyExperimental Treatment1 Intervention
Group II: Acetaminophen + oxycodoneExperimental Treatment2 Interventions
Group III: Acetaminophen + ibuprofen + oxycodoneExperimental Treatment3 Interventions
Group IV: Acetaminophen + ibuprofenExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Citations

AD-MW-36.04 Clinical Study Report Appendix Cover Page ...

Pain after Surgical Removal of Impacted Third Molars. Short Study Title. Efficacy Study of 300mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain ...

Therapeutics of Ibuprofen in Rheumatic and Other Chronic ...

There is evidence to show that ibuprofen is a safe and effective 'first-line' NSAID for many rheumatic patients. The evidence shows that mostly ...

Office-based andrology and male infertility procedures—a cost ...

Office-based surgical procedures under local anesthesia offer several potential advantages over those performed with general or monitored anesthesia, including ...

The analgesic effect of oral paracetamol in two strains ...

The use of orally administered paracetamol was deemed to be an ineffective analgesic for CBA/CaCrl and DBA/2JCrl mice undergoing vasectomy.

Vasectomy - Abstract

Pain should be controlled in a multimodal way, utilizing ice, supportive undergarments, acetaminophen, ibuprofen, and possible narcotics.

Opioids in Urology: How Well Are We Preventing ...

modems of pain control may yield the same results as opi- ates for pain management post-scrotal or testicular surg- eries. CONCLUSION. Preventative education ...

Subanalgesic doses of drug combinations

SAD of selected combination analgesics having an improved safety profile compared with usual doses of selected combination analgesics.

Chronic Pelvic Pain - Cloudfront.net

network meta-analysis has suggested significant effects in decreasing total symptom, pain, voiding, and QoL scores compared with placebo. ...

The ibuprofen dosage commonly taken by high-level athletes ...

The ibuprofen dosage commonly taken by high-level athletes can afflict their testicles with a condition normally seen only in elderly men and linked to lower ...

clinical protocol

Required washout from rescue medication (acetaminophen / paracetamol) use before clinic visits has been decreased from 48 to 24 hours of pain