Sacral Erector Spinae Plane Block in Normal Birth

NCT ID: NCT06221332

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2025-11-15

Brief Summary

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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

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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

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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SACRAL EREKTÖR SPİNAE PLANE BLOK

Pregnant women in Group S will be given 10 cc bupivacaine solution of 0.25% bupivacaine on both sides.

Group Type ACTIVE_COMPARATOR

% 0.25 bupivakain 20cc

Intervention Type OTHER

Pregnant women in group S will be given 0.25% bupivacaine, 10 cc on each side.

control group

Pregnant women in Group K will be injected with 10 cc of saline on both sides.

Group Type ACTIVE_COMPARATOR

20 cc saline

Intervention Type OTHER

Pregnant women in Group K will be given 10 cc of saline on both sides.

Interventions

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% 0.25 bupivakain 20cc

Pregnant women in group S will be given 0.25% bupivacaine, 10 cc on each side.

Intervention Type OTHER

20 cc saline

Pregnant women in Group K will be given 10 cc of saline on both sides.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Konya City Hospital

OTHER

Sponsor Role lead

Responsible Party

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Muhammed Halit Satici

Specialist, M.D., Department of members Anesthesiology and Reanimation, Konya City Hospital, M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MUHAMMED H SATICI, M.D.

Role: PRINCIPAL_INVESTIGATOR

Konya City Hospital

Locations

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Konya City Hospital

Konya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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MUHAMMED H SATICI, M.D

Role: CONTACT

5455636333 ext. +90

Facility Contacts

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MUHAMMED HALİT SATICI, M.D

Role: primary

5455636333 ext. +90

Other Identifiers

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vaginal birth

Identifier Type: -

Identifier Source: org_study_id

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