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Recruiting NCT06221332

Sacral Erector Spinae Plane Block in Normal Birth

No phase Interventional Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: % 0.25 bupivakain 20cc, 20 cc saline.
Who it may be relevant to
Registry conditions: Analgesia. Basic parameters: 18 years — 42 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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.

Overview

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 .

Interventions

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

Primary outcome measures

  • Quality of recovery (10T) scores [Time frame: One day]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Konya City Hospital — Konya

Identifiers

NCT: NCT06221332 · vaginal birth

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗