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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Aaron Brant, MD
- 電話番号：212-305-0114
- メール：menshealth@cumc.columbia.edu
研究場所
-
-
New York
-
New York、New York、アメリカ、10032
- 募集
- Columbia University Medical Center/ New York Presbyterian Hospital
-
コンタクト：
- Aaron Brant, MD
- 電話番号：212-305-0114
- メール：menshealth@cumc.columbia.edu
-
主任研究者：
- Aaron M Brant, MD
-
White Plains、New York、アメリカ、10604
- 募集
- New York-Presbyterian The One
-
コンタクト：
- Aaron Brant, MD
- 電話番号：212-305-0114
- メール：menshealth@cumc.columbia.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Consent for vasectomy
Exclusion Criteria:
- History of kidney or liver disease
- History of chronic pain condition
- History of drug abuse
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
|
|
実験的：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.
他の名前：
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.
他の名前：
|
|
実験的：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.
他の名前：
Oxycodone is a potent semi-synthetic opioid analgesic used to treat moderate to severe pain when other treatments are insufficient
他の名前：
|
|
実験的：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.
他の名前：
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and decrease inflammation.
他の名前：
Oxycodone is a potent semi-synthetic opioid analgesic used to treat moderate to severe pain when other treatments are insufficient
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Brief Pain Inventory (BPI) - Total Score
時間枠：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.
|
1 to 7 days post operatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Brief Pain Inventory (BPI) - Pain Interference Score
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Aaron Brant, MD、Columbia University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ACYY1239
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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