跳至主要内容
临床试验/NCT05780333
NCT05780333招募中不适用

Effect of Erector Spinae Plane Block and Transversus Abdominis Plane Block on Quality of Recovery and Postoperative Pain After Laparoscopic Hysterectomy; Randomized, Double-blinded Clinical Trial

Mentese State Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Quality of Recovery 40 Questionnaire

研究概览

简要总结

The goal of this clinical trial is to evaluate in effect of tap block and esp block on quality of recovery and postoperative pain after laparoscopic hysterectomy. The main question it aims to answer are: Are these two plane blocks used superior to each other? Participants;

  • will fill out the preoperative questionnaire
  • will fill out the postoperative questionnaire
  • will report their pain status according to the NRS score

详细描述

Standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). Generally, opiates and NSAIDs are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. The concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. It consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. Local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management.

Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the spinal nerves. And this block provides visceral and somatic pain block.

Transversus Abdominis plane (TAP) block involves the injection of LA between the transversus abdominis (TA) and internal oblique (IO) muscles.This interfascial plane contains the intercostal, subcostal, iliohypogastric, and ilioinguinal nerves. These nerves give sensation to the anterior and lateral abdominal wall as well as the parietal peritoneum, providing only somatic and not visceral analgesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients who will undergo hysterectomy under elective conditions
  • 18- 65 years
  • ASA I-II patients

排除标准

  • Refusal during registration, request to be excluded from the study, failure to give informed consent
  • Under 18 years old and upper 65 years old
  • ASA III-IV patients
  • Chronic opioid use
  • Presence of infection at the injection site
  • Renal failure / Liver failure
  • Bupivacaine sensitivity
  • Use of anticoagulants
  • BMI < 18,5 , BMI >35

结局指标

主要结局

Quality of Recovery 40 Questionnaire

时间窗: 24 hours after surgery.

The global Quality of Recovery-40 aggregate score is a scale from (1 to 5, where: 1 = very poor and 5 = excellent)

次要结局

  • Postoperative pain(24 hours after surgery.)

研究者

发起方
Mentese State Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Pelin Dilsiz Eker

MD., specialist

Mentese State Hospital

研究点 (2)

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