Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia (OLAA)
2014年2月1日 更新者：Fu Zhou Wang、Nanjing Medical University
Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control
It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control.
Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics.
However, we unavoidably encounter many opioid-associated side effects during the labor delivery.
In addition, usage of opioid increase the medical cost for each patient.
We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.
調査の概要
研究の種類
介入
入学 (実際)
500
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210004
- Nanjing Maternity and Child Health Care Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～45年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Nulliparas
- Request epidural analgesia
- Chinese
Exclusion Criteria:
- Allergic to opioid or local anesthetics
- Fail to perform epidural puncture and catheterization
- Organ dysfunction
- Contraindications for epidural anesthesia
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
|
0.125% ropivacaine 10-15 ml every 1h during labor delivery
他の名前：
|
|
アクティブコンパレータ：Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
|
Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
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 |
|---|---|---|
|
Pain scorings
時間枠：up to 3 days
|
Using visual analog scale (VAS) assess the pain intensity at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h for VAS pain 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
up to 3 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pruritus
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of pruritus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Dizziness
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of dizziness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Nausea
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of nausea at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Vomiting
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of vomiting at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Drowsiness
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of drowsiness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Sedation
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of sedation at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Respiratory depression
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of respiratory depression at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Psychological effects
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of psychological effects [euphoria, hallucinations, delirium and confusion] at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Myoclonus
時間枠：From post-randomization to post-delivery day 3
|
This describes muscle rigidity and abnormal movement of the limbs and muscles. Record incidence of myoclonus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. |
From post-randomization to post-delivery day 3
|
|
Maternal heart rate
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of maternal heart rate at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Miosis
時間枠：From post-randomization to post-delivery day 3
|
Record incidence of miosis at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
|
From post-randomization to post-delivery day 3
|
|
Cesarean section
時間枠：The time at the end of the labor delivery
|
Record the incidence of Cesarean section after completion of the labor delivery.
|
The time at the end of the labor delivery
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to latent phase
時間枠：From the beginning of regular contraction of uterus to the dilation of cervical 4cm
|
Record the time duration
|
From the beginning of regular contraction of uterus to the dilation of cervical 4cm
|
|
Time of active phase
時間枠：From the cervix 4cm to the dilation of cervical 10cm
|
Record the time duration
|
From the cervix 4cm to the dilation of cervical 10cm
|
|
Overall satisfaction of analgesia
時間枠：At the time of the end of the labor delivery
|
Assess the analgesia satisfaction after the completion of the labor delivery
|
At the time of the end of the labor delivery
|
|
Oxytocin usage
時間枠：At the time of the end of the labor
|
Record the total usage of oxytocin after completion of the labor delivery
|
At the time of the end of the labor
|
|
Neonatal Apgar score
時間枠：At the time of the baby was born, 1min, 5min, 10min and 20min
|
At the time of the baby was born, 1min, 5min, 10min and 20min
|
|
|
Instrumental delivery
時間枠：At the time of the end of the labor
|
Record the incidence of instrumental delivery after completion of the labor delivery.
|
At the time of the end of the labor
|
|
Umbilical gas analysis
時間枠：At the time of the fetus was delivery
|
At the time of the fetus was delivery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年9月1日
一次修了 (実際)
2014年2月1日
研究の完了 (実際)
2014年2月1日
試験登録日
最初に提出
2014年1月11日
QC基準を満たした最初の提出物
2014年1月13日
最初の投稿 (見積もり)
2014年1月14日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年2月4日
QC基準を満たした最後の更新が送信されました
2014年2月1日
最終確認日
2014年2月1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。