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RecruitingNCT06221332Updated Oct 8, 2024

Sacral Erector Spinae Plane Block in Normal Birth

An interventional study of % 0.25 bupivakain 20cc and 20 cc saline in Analgesia, sponsored by Konya City Hospital. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Konya City Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
Female
01

Study 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.

Read the 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 .

02

Conditions studied

  • Analgesia
03

In context

Lead sponsor

Konya City Hospital is the lead sponsor of 76 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • Active comparator
    control group

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

    Other: 20 cc saline

Interventions

  • Other% 0.25 bupivakain 20cc

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

  • Other20 cc saline

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

06

What researchers measure

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).

    Time frame: One day

07

Study locations

1 of 1 sites recruiting
  • Konya City Hospital
    Konya, 42020, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06221332
Lead sponsor
Konya City Hospital
Responsible party
Muhammed Halit Satici (Specialist, M.D., Department of members Anesthesiology and Reanimation, Konya City Hospital, M.D, Konya City Hospital) — Principal investigator
First posted
Jan 24, 2024
Start date
Jan 24, 2024
Primary completion
Sep 15, 2025 (estimated)
Completion
Nov 15, 2025 (estimated)
Last update
Oct 8, 2024

Study contacts

MUHAMMED H SATICI, M.D
Contact
halit_satici@hotmail.com
5455636333 ext. +90
MUHAMMED H SATICI, M.D.
principal investigator · Konya City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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