Sacral Erector Spinae Plane Block in Normal Birth

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: Analgesia
• Intervention / Treatment: Other: % 0.25 bupivakain 20cc; Other: 20 cc saline

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

• Study Contact: Name: Muhammed H SATICI, M.D; Phone Number: +90 5455636333; Email: halit_satici@hotmail.com

Study Locations

• Turkey
  • Konya, Turkey, 42020
    • Recruiting
    • Konya City Hospital
    • Contact: MUHAMMED HALİT SATICI, M.D; Phone Number: +90 5455636333; Email: halit_satici@hotmail.com

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

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.	Other: % 0.25 bupivakain 20cc; 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.	Other: 20 cc saline; 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	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

• Sponsor: Konya City Hospital
• Investigators: Principal Investigator: MUHAMMED H SATICI, M.D., Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): November 15, 2025

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): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 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