AnalgesiaNCT06221332
Sacral Erector Spinae Plane Block in Normal Birth
A study testing % 0.25 bupivakain 20cc and 20 cc saline in people with Analgesia, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- % 0.25 bupivakain 20cc and 20 cc saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2024to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya City Hospital
Konya, 42020
MUHAMMED HALİT SATICI, M.D, 5455636333 ext. +90, halit_satici@hotmail.com
About this study
Official title: 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.
Read the 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 .
- Conditions
- Analgesia
- Being tested
- % 0.25 bupivakain 20cc, 20 cc saline
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
% 0.25 bupivakain 20ccOther
Pregnant women in group S will be given 0.25% bupivacaine, 10 cc on each side.
20 cc salineOther
Pregnant women in Group K will be given 10 cc of saline on both sides.
| Study group | Role | What they receive |
|---|---|---|
| SACRAL EREKTÖR SPİNAE PLANE BLOK | Active comparator | Pregnant women in Group S will be given 10 cc bupivacaine solution of 0.25% bupivacaine on both sides. Receives: Other: % 0.25 bupivakain 20cc |
| control group | Active comparator | Pregnant women in Group K will be injected with 10 cc of saline on both sides. Receives: Other: 20 cc saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery (10T) scores
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).
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start24 Jan 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Halit Satici, Konya City Hospital
- Investigators
- MUHAMMED H SATICI, M.D., Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221332
- Sponsor's protocol ID
- vaginal birth
- Status last verified
- Oct 2024
- First submitted
- 27 Dec 2023
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sacral Erector Spinae Plane Block on the Quality of Recovery After Vaginal Birth: A Double-blind Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06221332
- Acronym / sponsor ID
- vaginal birth
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 24 Jan 2024 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SACRAL EREKTÖR SPİNAE PLANE BLOK | Active comparator | Other: % 0.25 bupivakain 20ccPregnant women in Group S will be given 10 cc bupivacaine solution of 0.25% bupivacaine on both sides. |
| control group | Active comparator | Other: 20 cc salinePregnant women in Group K will be injected with 10 cc of saline on both sides. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| % 0.25 bupivakain 20ccPregnant women in group S will be given 0.25% bupivacaine, 10 cc on each side. | Other | SACRAL EREKTÖR SPİNAE PLANE BLOK |
| 20 cc salinePregnant women in Group K will be given 10 cc of saline on both sides. | Other | control group |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
MUHAMMED H SATICI, M.D. principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing % 0.25 bupivakain 20cc and 20 cc saline in people with Analgesia, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Oct 2024. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MUHAMMED H SATICI, M.D (5455636333 ext. +90, halit_satici@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery (10T) scores (time frame: One day). 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 8 Oct 2024.