Estimation of Pain During Epidural Analgesia During Labor (PERIDANS)
Estimation of Pain During Epidural Analgesia During Labor - a Monocentric Study
Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. In 10-25% of cases the epidural does not give perfect results, causing it to test its effectiveness, which is mainly done by questioning the patient on mitigation or disappearance of pain. This collaboration of patients is sometimes limited in our care structure by the inability to assess or express the pain, mainly due to cultural differences or language barriers, which can represent up to 15% of women in our institution. This led to develop objective measures of pain techniques used at the bedside.
Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of the pupil, and parasympathetic system (pΣ).
The PD increases in response to painful stimulation, in proportion to the intensity of the nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain in patients under general anesthesia, but has been little studied in conscious subjects.
There are other permanent changes in the PD, due to constant interaction between Σ and pΣ systems. Few data have been published to date on this PD variability (PDV).
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
-
Saint-Etienne、フランス、42055
- Chu Saint-Etienne
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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:
- Obstetrical Labor
- Able to rate their pain using VAS
- dilatation of the cervix under 6 centimeters
- Written consent
Exclusion Criteria:
- - Not having a anesthesia consultation during the 48 hours before delivery
- With a contra-indication for an epidural
- To which an incident occurred during a previous epidural using a medication used in the study
- Operated a unilateral or bilateral ocular surgery modifying the possibilities of variation of pupil diameter
- general anesthesia in the seven days preceding delivery
- Carry a pacemaker or heart grafted
- Having Parkinson's disease history, insulin or non-insulin diabetes or chronic alcoholism
- Having cardiac arrhythmia (atrial fibrillation or frequent extrasystoles)
- Treated for hypertension by receptor antagonists of angiotensin type 2
- anti-arrhythmic treatment or blocker,
- Refusing to participate in the study
- With a contra-indication for the use of ropivacaine and sufentanil.
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：防止
- 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：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 |
|---|---|
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実験的：Patients
Pain assess by :
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Portable video pupillometer measures pupil diameter (PD) in patient during obstetrical labor
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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 |
|---|---|---|
|
Pupil diameter variability
時間枠：From baseline to fifteen minutes after start of Epidural regional anesthesia
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Compare Pupil Diameter Variability (PDV) measured before Epidural regional anesthesia and after Epidural regional anesthesia.
PDV is aera under the curve of Pupil Diameter from start of the contraction (baseline) to time to peak of the contraction.
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From baseline to fifteen minutes after start of Epidural regional anesthesia
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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 |
|---|---|---|
|
pupil diameter
時間枠：From baseline to fifteen minutes after start of Epidural regional anesthesia
|
Compare the Pupil Diameter measured five seconds after time to peak of contraction before Epidural regional anesthesia and after Epidural regional anesthesia
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From baseline to fifteen minutes after start of Epidural regional anesthesia
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Visual Analogic Scale (VAS)
時間枠：From baseline to fifteen minutes after start of Epidural regional anesthesia
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Compare the VAS measured at the end of contraction before Epidural regional anesthesia and after Epidural regional anesthesia.
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From baseline to fifteen minutes after start of Epidural regional anesthesia
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協力者と研究者
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
本研究に関する用語
その他の研究ID番号
- 1208078
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。