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Numerical Rating Pain ScoreNCT04981353

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

A study testing bilateral erector spinae plane block at T11 in people with Numerical Rating Pain Score and the Total Doses of Pethidine Needed Through-out Delivery Will be Measured, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
What is being tested?
bilateral erector spinae plane block at T11
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
5 Jul 2021to 5 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams University

    Cairo, Abbasia

Other trials in Egypt

About this study

Official title: 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.

Read the 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:

  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.

Being tested
bilateral erector spinae plane block at T11
Keywords
erector spinae plane block, normal vaginal delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bilateral erector spinae plane block at T11Procedure or surgery

    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

Study groups in NCT04981353
Study groupRoleWhat they receive
group 1Active comparator:(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
Receives: Procedure: bilateral erector spinae plane block at T11
group 2Active comparator(group 2) patients will receive pethidine 25mg doses if NRS >4.
Receives: Procedure: bilateral erector spinae plane block at T11

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: every 30 minutes throughout the delivery

Secondary outcomes (4)
  1. 1. the total doses of pethidine needed through-out delivery will be measured

    Measured: throughout the first stage of delivery

  2. 2. the incidence of failed delivery and need of cesarean section will be assessed

    Measured: throughout delivery time

  3. 3. the incidence of transient fetal bradycardia or deceleration after the administration of the block will be recorded

    Measured: immediately after administration of the block

  4. 4. ABGAR score of the neonate immediately after delivery and after 5min, 10min,15min after delivery. Will be recorded

    Measured: at birth , after 5 min., 10min., 15 min.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start5 Jul 2021
  3. Primary completion5 Sep 2021 (estimated)
  4. Study completion5 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04981353
Sponsor's protocol ID
FMASU R 134/2021
Status last verified
Jul 2021
First submitted
23 Jul 2021
Last updated
29 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing bilateral erector spinae plane block at T11 in people with Numerical Rating Pain Score and the Total Doses of Pethidine Needed Through-out Delivery Will be Measured, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. numerical rating pain score (NRS) during the course of delivery (time frame: every 30 minutes throughout the delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.

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