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

Primary Purpose

Numerical Rating Pain Score, the Total Doses of Pethidine Needed Through-out Delivery Will be Measured, the Incidence of Failed Delivery and Need of Cesarean Section Will be Assessed

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bilateral erector spinae plane block at T11
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Numerical Rating Pain Score focused on measuring erector spinae plane block, normal vaginal delivery

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group 1

group 2

Arm Description

:(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

(group 2) patients will receive pethidine 25mg doses if NRS >4.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2021
Last Updated
July 23, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04981353
Brief Title
Thoracic Erector Spinae Plane Block for Painless 1st Stage Normal Vaginal Delivery: Randomized Controlled Study
Official Title
Thoracic Erector Spinae Plane Block for painless1st Stage Normal Vaginal Delivery: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
September 5, 2021 (Anticipated)
Study Completion Date
October 5, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: the total doses of pethidine needed through-out delivery will be measured the incidence of failed delivery and need of cesarean section will be assessed the incidence of transient fetal bradycardia or deceleration after the administration of the block will be recorded 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Numerical Rating Pain Score, the Total Doses of Pethidine Needed Through-out Delivery Will be Measured, the Incidence of Failed Delivery and Need of Cesarean Section Will be Assessed, the Incidence of Transient Fetal Bradycardia or Deceleration After the Administration of the Block Will be Recorded, ABGAR Score of the Neonate
Keywords
erector spinae plane block, normal vaginal delivery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Active Comparator
Arm Description
:(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
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
(group 2) patients will receive pethidine 25mg doses if NRS >4.
Intervention Type
Procedure
Intervention Name(s)
bilateral erector spinae plane block at T11
Intervention Description
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
Primary Outcome Measure Information:
Title
1. numerical rating pain score (NRS) during the course of delivery
Description
1. numerical rating pain score (NRS) during the course of delivery will be recorded and compared
Time Frame
every 30 minutes throughout the delivery
Secondary Outcome Measure Information:
Title
1. the total doses of pethidine needed through-out delivery will be measured
Time Frame
throughout the first stage of delivery
Title
2. the incidence of failed delivery and need of cesarean section will be assessed
Time Frame
throughout delivery time
Title
3. the incidence of transient fetal bradycardia or deceleration after the administration of the block will be recorded
Time Frame
immediately after administration of the block
Title
4. ABGAR score of the neonate immediately after delivery and after 5min, 10min,15min after delivery. Will be recorded
Time Frame
at birth , after 5 min., 10min., 15 min.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Abbasia
Country
Egypt

12. IPD Sharing Statement

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

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