Sacral Erector Spinae Plane Block in Normal Birth

Analgesia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221332
• Other study ID #: vaginal birth
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: June 2024
• Source: Konya City Hospital
• Contact: MUHAMMED H SATICI, M.D
• Phone: 5455636333
• Email: halit_satici[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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)

Related Conditions & MeSH terms

• Analgesia

Intervention

Other:
• % 0.25 bupivakain 20cc
Pregnant women in group S will be given 0.25% bupivacaine, 10 cc on each side.
• 20 cc saline
Pregnant women in Group K will be given 10 cc of saline on both sides.

Locations

Country	Name	City	State
Turkey	Konya City Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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