Analgesia in Labor, a Prospective Parallel Study to Compare Regional Analgesia and Intravenous (IV) Pethidine Analgesia
Analgesia in Labor, a Prospective Parallel Single Blind Study to Compare Regional Analgesia (Combined Spinal Epidural Analgesia (CSE), Epidural Analgesia (E)) and Intravenous (IV) Pethidine Analgesia
調査の概要
詳細な説明
This is a prospective parallel single blind study, which was approved by the institutional review board of El-Galaa Teaching Hospital, and the research and ethics committee of Faculty of Pharmacy, Cairo University.
This hospital per si was selected for the study because it is large hospital that could provide the study with a diverse population. It has a population of various socio-economic statuses. This would provide the study with a sample of patients with a wide range of characteristics.
Sixty full-term, ASA physical status I or II nulliparous women in active labor with cervical dilatation of 5 cm and cephalic presenting fetus were randomly assigned to one of five groups after providing informed consent.
- Group 1: received CSE analgesia, where 25 µg of fentanyl was injected intrathecally and a bolus dose of 10 ml of 0.5% lidocaine was injected epidurally. E top-ups of 5-10 ml of 0.5-0.8% lidocaine were then injected upon request.
- Group 2: received CSE analgesia, where 25 µg of fentanyl was injected intrathecally and a bolus dose of 10 ml of 0.0625% bupivacaine was injected epidurally. E top-ups of 5-10 ml of 0.0625-0.25% bupivacaine were then injected upon request.
- Group 3: received 50µg of E fentanyl analgesia which was injected intrathecally and a bolus of 10 ml of 0.5% lidocaine was administered through the catheter, followed by lidocaine E top-ups of 5-10 ml of 0.5-0.8% upon request.
- Group 4: received analgesia, where 50 µg of E fentanyl were injected intrathecally and a bolus dose of 10 ml of 0.125% bupivacaine was administered through the catheter, followed by E bupivacaine top-ups of 5-10 ml of 0.125-0.25% upon request.
- Group 5: 50 mg of IV pethidine was administered as a loading dose, followed by 0.5 mg/kg, with a total maximum limit of 130 mg.
Study Subjects Excluding Criteria Patients who had diabetes mellitus, neurological disease, pre-eclampsia, or patients who had received parenteral analgesics or patients with contraindication to E or spinal analgesia, or patients with sensitivity to local anesthetics or opioids were excluded from the study.
Study Method All the recruited subjects were screened before the administration of any analgesia. Systolic and diastolic pressures, heart rate and peripheral oxygen saturation (SpO2) were monitored. Fetal heart rate (FHR) was monitored using an external cardiotocograph monitor (Partoconter NST Nihon Kohden).
For the E groups, the degree of motor block was assessed according to a modified Bromage scale (Grade I: free movement of legs and feet; Grade II: just able to flex knees with free movement of feet; Grade III: unable to flex knees, but with free movements of feet; Grade IV: unable to move legs or feet) before administration of E analgesia, 10 and 30 minutes after the first dose. The start of the analgesia was regarded as time 0. The duration of analgesia was taken as the time from the beginning of analgesic injection (time 0) to the time of request for additional analgesia.
The number of analgesic top-ups was recorded and the intervals between each top-up, in addition to the volume and concentration of the drug injected.
The Visual Analogue Pain Scale (VAS) (0 mm = no pain, 100 mm = worst pain imaginable) was measured before administration of analgesia, 10 and 30 minutes after administration of each analgesic dose until the delivery of the baby.
Maternal arterial pressures, heart rate, SpO2, and FHR were noted before the analgesia was given, and afterwards every 30 minutes until delivery.
Maternal temperature was recorded before starting the analgesic regimen and thereafter every hour till the end of labor. Fever was defined as temperature of ≥ 38˚C.
The duration of each stage of labor together with the mode of delivery were recorded.
The total volume of drug injected, total concentration of drug injected, 1-min and 5-min APGAR scores, weight of the neonate were recorded.
Any experienced drug related problem by any of the recruited subjects were recorded.
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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Cairo、エジプト
- El-Galaa 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:
full-term, ASA physical status I or II nulliparous women in active labor with cervical dilatation of 5 cm and cephalic presenting fetus
Exclusion Criteria:
Patients who had diabetes mellitus, neurological disease, pre-eclampsia, or patients who had received parenteral analgesics or patients with contraindication to E or spinal analgesia, or patients with sensitivity to local anesthetics or opioids were excluded from the study.
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: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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アクティブコンパレータ:Epidura, combined spinal epidura & IV
Gp 1: received CSE analgesia, 25µg of fentanyl injected intrathecally & a bolus of 10 ml of 0.5% lidocaine injected epidurally. Gp 2: received CSE analgesia, 25µg of fentanyl injected intrathecally & a bolus of 10 ml of 0.0625% bupivacaine injected epidurally. Gp 3: received 50µg of E fentanyl analgesia, injected intrathecally & a bolus of 10 ml of 0.5% lidocaine, followed by lidocaine E top-ups. Gp 4: received 50µg of E fentanyl injected intrathecally and a bolus dose of 10 ml of 0.125% bupivacaine, followed by E bupivacaine top-ups. Gp 5: 50mg of IV pethidine was administered as a loading dose, followed by 0.5 mg/kg. |
Gp 1: received CSE analgesia: 25µg of fentanyl & a bolus dose of 10 ml of 0.5% lidocaine was injected epidurally. E top-ups of 5-10 ml of 0.5-0.8% lidocaine were then injected. Gp 2: received CSE analgesia: 25µg of fentanyl & a bolus dose of 10 ml of 0.0625% bupivacaine was injected epidurally. E top-ups of 5-10 ml of 0.0625-0.25% bupivacaine were then injected. Gp 3: received 50µg of E fentanyl analgesia & a bolus of 10 ml of 0.5% lidocaine was administered, followed by lidocaine E top-ups of 5-10 ml of 0.5-0.8%. Gp 4: received analgesia: 50µg of E fentanyl & a bolus dose of 10 ml of 0.125% bupivacaine was administered, followed by E bupivacaine top-ups of 5-10 ml of 0.125-0.25%. Gp 5: 50mg of IV pethidine was administered as loading dose, followed by 0.5 mg/kg. |
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 |
---|---|---|
Visual Analogue Scale to assess pain control
時間枠:24 hours
|
The Visual Analogue Pain Scale (VAS) (0 mm = no pain, 100 mm = worst pain imaginable) was measured before administration of analgesia, 10 and 30 minutes after administration of each analgesic dose until the delivery of the baby.
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24 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The degree of motor block
時間枠:24 hours
|
The degree of motor block was assessed according to a modified Bromage scale (Grade I: free movement of legs and feet; Grade II: just able to flex knees with free movement of feet; Grade III: unable to flex knees, but with free movements of feet; Grade IV: unable to move legs or feet) before administration of E analgesia, 10 and 30 minutes after the first dose.
The start of the analgesia was regarded as time 0. The duration of analgesia was taken as the time from the beginning of analgesic injection (time 0) to the time of request for additional analgesia.
|
24 hours
|
Number of top-ups
時間枠:24 hours
|
The number of analgesic top-ups was recorded and the intervals between each top-up, in addition to the volume and concentration of the drug injected.
|
24 hours
|
Adverse effects
時間枠:24 hours
|
Any experienced drug related problem by any of the recruited subjects were recorded.
|
24 hours
|
Labour Duration
時間枠:24 hours
|
The duration of each stage of labor together with the mode of delivery were recorded.
|
24 hours
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Nirmeen Sabry, Ph.D、Cairo 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
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Epidura, CSE & IVの臨床試験
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Mayo ClinicUniversity of British Columbia招待による登録