- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06221332
Sacral Erector Spinae Plane Block in Normal Birth
April 15, 2024 updated by: Muhammed Halit Satici, Konya City Hospital
The Effect of Sacral Erector Spinae Plane Block on the Quality of Recovery After Vaginal Birth: A Double-blind Prospective Randomized Controlled Study.
Pregnant women feel severe pain during normal birth and in the postpartum period.
Preventing pain during and after birth is very important for both the mother and the baby.
Rapid recovery in the postoperative period in pregnant women is very important for both mother and baby.
To evaluate this recovery, the quality of recovery-10 scores developed by Shalev et al. are used in pregnant women.
Our study will be the first in the literature to use sacral erectör spinae plane block (S-ESPB) in normal birth.
Our primary aim in this study is to evaluate the effects of S-ESPB on the quality of recovery and recovery at the 24th hour in pregnant women who will undergo vaginal birth with epidural analgesia, using the Quality of Recovery-10T scores.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Pregnant women feel severe pain during normal birth and in the postpartum period.
Preventing pain during and after birth is very important for both the mother and the baby.
Rapid recovery in the postoperative period in pregnant women is very important for both mother and baby.
To evaluate this recovery, the quality of recovery-10 scores developed by Shalev et al. are used in pregnant women.
Our study will be the first in the literature to use sacral erectör spinae plane block in normal birth.
Our primary aim in this study is to evaluate the effects of sacral erectör spinae plane block on the quality of recovery and recovery at the 24th hour in pregnant women who will undergo vaginal birth with epidural analgesia, using the Quality of recovery-10T score.
the numeric rating scale at the 0-15th minute-30th minute-45th minute-1-2-4-8-12-24th hour after the S-ESPB application, and to evaluate the patient satisfaction at the 24th hour with a Likert scale.
, the total amount of rescue analgesic ( bupivacaine ) consumed since the application of sacral erectör spinae plane block, the number of pregnant women given oxytocin, the time of the first breastfeeding, complications in the mother (fever, nausea, vomiting, motor block, hip pain), the need for antiemetics, the baby's 1st and 5th minutes.
Apgar score at the 1st-2nd-3rd week of birth. is to evaluate the duration of the phases .
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MUHAMMED H SATICI, M.D
- Phone Number: +90 5455636333
- Email: halit_satici@hotmail.com
Study Locations
-
-
-
Konya, Turkey, 42020
- Recruiting
- Konya City Hospital
-
Contact:
- MUHAMMED HALİT SATICI, M.D
- Phone Number: +90 5455636333
- Email: halit_satici@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 36-42. Pregnant women who are their gestational age and request epidural anesthesia
- Pregnant women aged 18-42 with ASA II
- Pregnant women who will stay in the hospital for at least 24 hours
- Primiparous pregnant women who will have a planned normal birth
- Singleton births with vertex presentation
Exclusion Criteria:
- Pregnant women who do not want to give consent
- Regional anesthesia is contraindicated
- Pregnant women who use anticoagulants and have an abnormal bleeding profile
- Pregnant women with infection in the area to be treated
- Emergency cases and pregnant women who had a birth with instruments (forceps and vacuum)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SACRAL EREKTÖR SPİNAE PLANE BLOK
Pregnant women in Group S will be given 10 cc bupivacaine solution of 0.25% bupivacaine on both sides.
|
Pregnant women in group S will be given 0.25% bupivacaine, 10 cc on each side.
|
Active Comparator: control group
Pregnant women in Group K will be injected with 10 cc of saline on both sides.
|
Pregnant women in Group K will be given 10 cc of saline on both sides.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of recovery (10T) scores
Time Frame: One day
|
The primary evaluation criterion will be the recording of Quality of Recovery-10T scores, which indicate the quality of recovery of pregnant women at the 24th hour after birth.
Quality of Recovery-10T ( Minumum: 0 = Very bad, Maximum: 100= Perfect).
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: MUHAMMED H SATICI, M.D., Konya City Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2024
Primary Completion (Estimated)
June 15, 2024
Study Completion (Estimated)
June 15, 2024
Study Registration Dates
First Submitted
December 27, 2023
First Submitted That Met QC Criteria
January 14, 2024
First Posted (Actual)
January 24, 2024
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- vaginal birth
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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