CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens (SSS)
Combined Spinal Epidural Analgesia in Labour: A Comparison of Two Intrathecal Regimens of Single Shot Spinal
Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall cost of Epidural services in terms of human personnel and financial implication makes this inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier option that can produce as much satisfaction for the parturient and would allow her participate in the second stage of labour by being able to bare down is being studied.
The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back is its time limitation as the option of a top up is not available.
Two regimen of drug options would be considered using opioids. These would be compared to see how well they are able to provide analgesia in women who hitherto have had vaginal birth. Their onset, duration of action and possible side effects would be compared.
NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a statistically significant difference in labour analgesia in comparison with Bupivacaine Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a statistically significant difference in labour in comparison with BFM
調査の概要
詳細な説明
A double blinded randomized study comparing 2 intrathecal mixtures for labour analgesia.
94 multiparous parturients in active labour who have given informed consent would be recruited into the study. They would be randomly allocated into 2 groups using simple random sampling. An Assistant would know the code and prepare the intrathecal solutions.
Baseline vitals would be taken and patient's pain score noted. Due protocol would be followed and a combined spinal epidural sited but with the epidural not activated until the effect of the spinal wears off.
Routine monitoring would be done and various parameters and indices noted. Where the effect of the spinal lasts the duration of labour thus no need to activate the epidural, this would also be noted.
Data would be analysed using Statistical Package of Social Sciences (SPSS) version 20.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
Lagos、ナイジェリア
- Lagos Island Maternity Centre
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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:
- Parturients in active labour >4cm dilatation
- American Society of Anesthesiologists (ASA) classification I and II
Exclusion Criteria:
- Significant co-morbidities like uncontrolled hypertension or diabetes
- Maternal hemorrhage with hypotension
- Significant bleeding/clotting disorders
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：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：BF
Interventions: Intrathecal administration -Bupivacaine 2.5mg (0.5ml) + Fentanyl 25mcg (0.5ml) + 1ml sterile water in one shot Ephedrine 3-5mg in aliquots in the event of hypotension Promethazine 12.5 - 25mg in the event of vomiting or significant pruritus naloxone 2mcg/kg in the event of respiratory distress
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Dosages as previously written
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アクティブコンパレータ：BFM
Interventions: Intrathecal administration - Bupivacaine 2.5mg (0.5ml) + fentanyl 25mcg (0.5ml) + 0.25mg morphine (0.25ml) + 0.75ml sterile water in one shot ephedrine 3-5mg in aliquots for hypotension Promethazine 12.5 - 25mg for vomiting or significant pruritus Naloxone 2mcg/kg in the event of respiratory distress
|
Dosage as previously written
|
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 |
|---|---|---|
|
Time to First painless contraction (TFC)
時間枠：time zero to first painless contraction estimated 15 minutes
|
This is the onset of action of the drugs.
The time duration from the initiation of the block at time zero to the point where there is significant drop in the Numerical Rating Scale (NRS) to 2 or less
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time zero to first painless contraction estimated 15 minutes
|
|
Time to First Request for Analgesia (TFA)
時間枠：Time zero till NRS > 6 estimated 180 minutes
|
This is the duration of action of the block.
Time from initiation of the block to time the pain score is up to 6 or more.
It is expected that after onset of the block (TFC) the pain would first become negligible or absent and after a period of time, it would gradually increase as the drug wears off.
If the pain becomes moderate at a NRS of 6 or the patient requests for analgesia, the time would be noted and the epidural would be activated.
|
Time zero till NRS > 6 estimated 180 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Delivery before TFA or delivery after TFA
時間枠：duration of labour estimated 180 minutes
|
Qualitative variable.
determines if rescue analgesia was needed (if the epidural needed to be activated) or if the spinal was adequate for the duration of labour
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duration of labour estimated 180 minutes
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Maternal Satisfaction
時間枠：up to 300 minutes
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Parturients perception of if analgesia was Adequate, Inadequate or Not Sure
|
up to 300 minutes
|
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Side effects
時間枠：up to 180 minutes
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Presence of side effects like respiratory depression, pruritus, or vomiting
|
up to 180 minutes
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Olaniyi Oladapo, MBBS,FMCA, FWACS、School of Anaesthetic Studies, Health Service Commission, Lagos State
出版物と役立つリンク
一般刊行物
- Minty RG, Kelly L, Minty A, Hammett DC. Single-dose intrathecal analgesia to control labour pain: is it a useful alternative to epidural analgesia? Can Fam Physician. 2007 Mar;53(3):437-42.
- Lee BB, Ngan Kee WD, Hung VY, Wong EL. Combined spinal-epidural analgesia in labour: comparison of two doses of intrathecal bupivacaine with fentanyl. Br J Anaesth. 1999 Dec;83(6):868-71. doi: 10.1093/bja/83.6.868.
- Hess PE, Vasudevan A, Snowman C, Pratt SD. Small dose bupivacaine-fentanyl spinal analgesia combined with morphine for labor. Anesth Analg. 2003 Jul;97(1):247-52, table of contents. doi: 10.1213/01.ane.0000066520.30763.b8.
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
- SAS/17/03
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
米国で製造され、米国から輸出された製品。
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陣痛の臨床試験
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Bupivacaine-fentanylの臨床試験
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University Hospitals Cleveland Medical Center募集
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Tanta University完了