跳至主要内容
临床试验/NCT06221332
NCT06221332招募中不适用

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

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Quality of recovery (10T) scores

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

SACRAL EREKTÖR SPİNAE PLANE BLOK

Active Comparator

Pregnant women in Group S will be given 10 cc bupivacaine solution of 0.25% bupivacaine on both sides.

干预措施: % 0.25 bupivakain 20cc (Other)

control group

Active Comparator

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

干预措施: 20 cc saline (Other)

结局指标

主要结局

Quality of recovery (10T) scores

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Halit Satici

Specialist, M.D., Department of members Anesthesiology and Reanimation, Konya City Hospital, M.D

Konya City Hospital

研究点 (1)

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Sacral Erector Spinae Plane Block in Normal Birth | 临床试验