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NCT Number: NCT06221332

Sacral Erector Spinae Plane Block in Normal Birth

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Location status: Recruiting

Location contact

MUHAMMED HALİT SATICI, M.D

CONTACT

[email protected]

5455636333 ext. +90

About this 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 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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

% 0.25 bupivakain 20cc

Other

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

20 cc saline

Other

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

Primary outcomes

  1. Quality of recovery (10T) scores

    Time frame: One day

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

MUHAMMED H SATICI, M.D

CONTACT

[email protected]

5455636333 ext. +90

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

The Effect of Sacral Erector Spinae Plane Block on the Quality of Recovery After Vaginal Birth: A Double-blind Prospective Randomized Controlled Study.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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