Sacral Erector Spinae Plane Block in Normal Birth

NCT06221332 | Recruiting

• 1 other identifier: vaginal birth
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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).

  One day

Study Arms (2)

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.

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.

Other: 20 cc saline

Interventions

% 0.25 bupivakain 20cc OTHER

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

SACRAL EREKTÖR SPİNAE PLANE BLOK

20 cc saline OTHER

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

control group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Pregnant women who will have normal birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MUHAMMED H SATICI, M.D.

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUHAMMED H SATICI, M.D

CONTACT

5455636333; halit_satici@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, M.D., Department of members Anesthesiology and Reanimation, Konya City Hospital, M.D

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 24, 2024
• Study Start: January 24, 2024
• Primary Completion: September 15, 2025
• Study Completion: November 15, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

TU (1)