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.
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
- Conditions the study is for
- 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
- What is being tested?
- bilateral erector spinae plane block at T11
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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:
- 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.
- Conditions
- 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
- 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 group | Role | What they receive |
|---|---|---|
| group 1 | Active 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 2 | Active 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. numerical rating pain score (NRS) during the course of delivery
- 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. the total doses of pethidine needed through-out delivery will be measured
Measured: throughout the first stage of delivery
2. the incidence of failed delivery and need of cesarean section will be assessed
Measured: throughout delivery time
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. 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.
- First posted29 Jul 2021
- Study start5 Jul 2021
- Primary completion5 Sep 2021 (estimated)
- Study completion5 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Numerical Rating Pain ScoreStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa adel, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Erector Spinae Plane Block for painless1st Stage Normal Vaginal Delivery: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04981353
- Acronym / sponsor ID
- FMASU R 134/2021
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 5 Sep 2021 (estimated)
- Study completion
- 5 Oct 2021 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: bilateral erector spinae plane block at T11:(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 | Active comparator | Procedure: bilateral erector spinae plane block at T11(group 2) patients will receive pethidine 25mg doses if NRS >4. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant ladies 37-40 weeks of gestation scheduled for normal vaginal delivery ASA 2 either prime or multipara
Key exclusion criteria (1 listed)
- pregnant ladies with complicated pregnancy eg; IUGR,accidental hemorrhage, preeclampsia pregnant ladies scheduled for cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral erector spinae plane block at T11A 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 | Procedure or surgery | group 1, group 2 |
Primary outcome
1. numerical rating pain score (NRS) during the course of delivery
Time frame: every 30 minutes throughout the delivery
1. numerical rating pain score (NRS) during the course of delivery will be recorded and compared
4 secondary outcomes
1. the total doses of pethidine needed through-out delivery will be measured
Time frame: throughout the first stage of delivery
2. the incidence of failed delivery and need of cesarean section will be assessed
Time frame: throughout delivery time
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 6 Nov 2026.