NSAIDs, Post-operative Care, Vasectomy
Conditions
Keywords
vasectomy, NSAIDs, Post-operative care
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.
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.
Interventions
DRUGAcetaminophen
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.
DRUGibuprofen
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.
DRUGoxycodone
Oxycodone is a potent semi-synthetic opioid analgesic used to treat moderate to severe pain when other treatments are insufficient
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Consent for vasectomy
Exclusion criteria
* History of kidney or liver disease * History of chronic pain condition * History of drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) - Total Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) - Pain Interference Score | 1 to 7 days post operatively | The Pain Interference Score ranges from 0 to 10, where a higher score indicates greater interference with daily life. |
| Brief Pain Inventory (BPI) - Pain Severity Score | 1 to 7 days post operatively | The Pain Severity Score ranges from 0 to 10, where a higher score indicates greater severity. |
Countries
United States
Contacts
CONTACTAaron Brant, MD
PRINCIPAL_INVESTIGATORAaron Brant, MD
Columbia University
Outcome results
None listed