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Thoracic Erector Spinae Plane Block for Painless 1st Stage Normal Vaginal Delivery: Randomized Controlled Study

2021年7月23日 更新者:Asmaa adel、Ain Shams University

Thoracic Erector Spinae Plane Block for painless1st Stage Normal Vaginal Delivery: Randomized Controlled Study

this study will test a novel indication for bilateral erector spinae plane block (painless 1st stage normal vaginal delivery) it depends on the hypnosis that the erector spinae plane block blocks the visceral pain also by affecting the ventral rami, dorsal rami and rami communicants.

調査の概要

詳細な説明

Aim of the work In this article, the efficacy of bilateral thoracic (ESP) to provide painless delivery without affecting the motor power (walking painless labor) will be studded.

The main objective:

1. numerical rating pain score (NRS) during the course of delivery will be recorded and compared.

Other objectives:

  1. the total doses of pethidine needed through-out delivery will be measured
  2. the incidence of failed delivery and need of cesarean section will be assessed
  3. the incidence of transient fetal bradycardia or deceleration after the administration of the block will be recorded
  4. ABGAR score of the neonate immediately after delivery and after 5min, 10min,15min after delivery. Will be recorded

Inclusion criteria :

Pregnant ladies aged 20-40 years, ASA 2, either prime or multipara , 37-40 weeks of gestation scheduled for vaginal delivery will be included in the study Exclusion criteria Pregnant ladies with complicated pregnancy eg; IUGR, accidental hemorrhage, preeclampsia Pregnant ladies scheduled for cesarean section Place of work: Labor ward in obstetric Department, Ain Shams University Hospital.

Sample size: all patients legible for the study will be enrolled and randomly allocated into one of the two groups. sample size was calculated using PASS 11.0 and based on a study carried out by Boules,2020. Group sample size of 15 in group 1 and 15 in group 2 achieves 100% power to detect difference of -4.0 between the null hypothesis that both group means are 2.0 and the alternative hypothesis that the mean of group 2 is 6.0 with estimated group standard deviations of 0.3 and a significance level (alpha ) of 0.05000 using a two-sided two-sample t-test. Sample size was inflated by 20% to account for attrition problem.

Methodology :

After taking the approval from Ain shams university ethical committee and informed consent from the pregnant ladies that will be legible for the study, detailed medical history of the patient will be taken and patient will be transported to operating room and basic monitors including ( ECG, pulse oximetry, NIBP)will be attached and basic reading of CTG will be recorded after that patient will be enrolled in two groups :(group 1) will be putted in sitting position and disinfecting her back. A real-time high-frequency linear ultrasound will be used to do the thoracic (ESP) at the level of T11 by visualizing the transverse process of T11 thoracic vertebrae and erector spinae muscle and injecting a 20 ml of bupivacaine 0.25% bilaterally using an in-plane technique, a 20-gauge, 70-mm needle (Tuoren, Henan, China) will be advanced into the plane below (ESM) after injecting lidocaine 1% 2ml at the site of injection, Needle will be advanced with a cranial to caudal direction (Boules et al,2020). (group 2) patients will receive pethidine 25mg doses if NRS >4. Patients of both groups will be positioned semi setting and CTG will be attached to her , blood pressure and maternal pulsations will be recorded every 15min throughout the delivery process. CTG records all over the labor time will be printed. Numerical rating scale (NRS) are the simplest and most widely used scale. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." The patient draws a circle around the number that best describes the pain intensity. Advantages of NRS include simplicity, reproducibility, easy comprehensibility, and sensitivity to small changes in pain. It will be assessed every 30 min. throughout the delivery process. 25mg pethidine iv will be given if NRS >4 in both groups.

Endpoints of this study:

One hour after delivery of the newborn.

研究の種類

介入

入学 (実際)

30

段階

  • 適用できない

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

    • Abbasia
      • Cairo、Abbasia、エジプト
        • Ain Shams University

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

20年~40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:

  • pregnant ladies 37-40 weeks of gestation scheduled for normal vaginal delivery ASA 2 either prime or multipara

Exclusion Criteria:

  • pregnant ladies with complicated pregnancy eg; IUGR,accidental hemorrhage, preeclampsia pregnant ladies scheduled for cesarean section

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:独身

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:group 1
:(group 1) will be putted in sitting position and disinfecting her back. A real-time high-frequency linear ultrasound will be used to do the thoracic (ESP) at the level of T11 by visualizing the transverse process of T11 thoracic vertebrae and erector spinae muscle and injecting a 20 ml of bupivacaine 0.25% bilaterally using an in-plane technique, a 20-gauge, 70-mm needle (Tuoren, Henan, China) will be advanced into the plane below (ESM) after injecting lidocaine 1% 2ml at the site of injection, Needle will be advanced with a cranial to caudal direction
A real-time high-frequency linear ultrasound will be used to do the thoracic (ESP) at the level of T11 by visualizing the transverse process of T11 thoracic vertebrae and erector spinae muscle and injecting a 20 ml of bupivacaine 0.25% bilaterally using an in-plane technique, a 20-gauge, 70-mm needle (Tuoren, Henan, China) will be advanced into the plane below (ESM) after injecting lidocaine 1% 2ml at the site of injection, Needle will be advanced with a cranial to caudal directio
アクティブコンパレータ:group 2
(group 2) patients will receive pethidine 25mg doses if NRS >4.
A real-time high-frequency linear ultrasound will be used to do the thoracic (ESP) at the level of T11 by visualizing the transverse process of T11 thoracic vertebrae and erector spinae muscle and injecting a 20 ml of bupivacaine 0.25% bilaterally using an in-plane technique, a 20-gauge, 70-mm needle (Tuoren, Henan, China) will be advanced into the plane below (ESM) after injecting lidocaine 1% 2ml at the site of injection, Needle will be advanced with a cranial to caudal directio

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
1. numerical rating pain score (NRS) during the course of delivery
時間枠:every 30 minutes throughout the delivery
1. numerical rating pain score (NRS) during the course of delivery will be recorded and compared
every 30 minutes throughout the delivery

二次結果の測定

結果測定
時間枠
1. the total doses of pethidine needed through-out delivery will be measured
時間枠:throughout the first stage of delivery
throughout the first stage of delivery
2. the incidence of failed delivery and need of cesarean section will be assessed
時間枠:throughout delivery time
throughout delivery time
3. the incidence of transient fetal bradycardia or deceleration after the administration of the block will be recorded
時間枠:immediately after administration of the block
immediately after administration of the block
4. ABGAR score of the neonate immediately after delivery and after 5min, 10min,15min after delivery. Will be recorded
時間枠:at birth , after 5 min., 10min., 15 min.
at birth , after 5 min., 10min., 15 min.

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。

スポンサー

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 (実際)

2021年7月5日

一次修了 (予想される)

2021年9月5日

研究の完了 (予想される)

2021年10月5日

試験登録日

最初に提出

2021年7月23日

QC基準を満たした最初の提出物

2021年7月23日

最初の投稿 (実際)

2021年7月29日

学習記録の更新

投稿された最後の更新 (実際)

2021年7月29日

QC基準を満たした最後の更新が送信されました

2021年7月23日

最終確認日

2021年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • FMASU R 134/2021

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