Hydromorphone and C-section
Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief
This study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. Secondary objectives include determining the average amount of time patients obtain pain relief after injection. Other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.
After the intrathecal injection is given, patients will undergo their cesarean section. The patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. The patient's medical record will be reviewed to determine when she first requested supplemental pain medication. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be assessed.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30303
- Grady Memorial Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy women undergoing cesarean section
Exclusion Criteria:
- Any comorbidities other than obesity, hypertension, fetal anomalies
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:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Hydromorphone
Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
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Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
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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 |
|---|---|---|
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Pain Scores, Visual Analogue Pain Scale
時間枠:12 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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12 hours after intrathecal injection
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Scores, Visual Analogue Pain Scale
時間枠:Baseline
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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Baseline
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Pain Scores, Visual Analogue Pain Scale
時間枠:6 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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6 hours after intrathecal injection
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Pain Scores, Visual Analogue Pain Scale
時間枠:18 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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18 hours after intrathecal injection
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Pain Scores, Visual Analogue Pain Scale
時間枠:24 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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24 hours after intrathecal injection
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Grant C Lynde, MD、Emory University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。