Post-Vasectomy Pain RCT
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Aaron Brant, MD
- 电话号码：212-305-0114
- 邮箱：menshealth@cumc.columbia.edu
学习地点
-
-
New York
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New York、New York、美国、10032
- 招聘中
- Columbia University Medical Center/ New York Presbyterian Hospital
-
接触：
- Aaron Brant, MD
- 电话号码：212-305-0114
- 邮箱：menshealth@cumc.columbia.edu
-
首席研究员：
- Aaron M Brant, MD
-
White Plains、New York、美国、10604
- 招聘中
- New York-Presbyterian The One
-
接触：
- Aaron Brant, MD
- 电话号码：212-305-0114
- 邮箱：menshealth@cumc.columbia.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Consent for vasectomy
Exclusion Criteria:
- History of kidney or liver disease
- History of chronic pain condition
- History of drug abuse
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
其他名称：
|
|
实验性的：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.
|
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.
其他名称：
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.
其他名称：
|
|
实验性的：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.
|
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.
其他名称：
Oxycodone is a potent semi-synthetic opioid analgesic used to treat moderate to severe pain when other treatments are insufficient
其他名称：
|
|
实验性的：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.
|
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.
其他名称：
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.
其他名称：
Oxycodone is a potent semi-synthetic opioid analgesic used to treat moderate to severe pain when other treatments are insufficient
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Brief Pain Inventory (BPI) - Total Score
大体时间：1 to 7 days post operatively
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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.
|
1 to 7 days post operatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Brief Pain Inventory (BPI) - Pain Interference Score
大体时间：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.
|
1 to 7 days post operatively
|
|
Brief Pain Inventory (BPI) - Pain Severity Score
大体时间：1 to 7 days post operatively
|
The Pain Severity Score ranges from 0 to 10, where a higher score indicates greater severity.
|
1 to 7 days post operatively
|
合作者和调查者
调查人员
- 首席研究员：Aaron Brant, MD、Columbia University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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