跳至主要内容
临床试验/NCT05259345
NCT05259345Enrolling By Invitation不适用

Comparison of Subcostal Exterior Semilunaris Transverses Abdomens, Modified Thoracoabdominal Nerves Block Through Perichondrial Approach, and Rectus Sheath Block in Patients Undergoing Major Abdominal Surgeries

Inonu University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
2
主要终点
Quality of Recovery

研究概览

简要总结

The aim of this randomised controlled study is to compare the effects of three different fascial plane block [subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block, modified thoracoabdominal nerves block through perichondrial approach (M-TAPA), and rectus sheath block (RSB)] on postoperative pain levels and opioid consumption in patients undergoing major abdominal surgeries with midline incision.

详细描述

In last decade,ultrasound guided truncal fascial plane blocks such as transverses abdominis plane (TAP) block and rectus sheath block (RSB) have become popular as a part of postoperative multimodal analgesia for abdominal surgeries as the techniques are simple and the target sites are easily identify. Furthermore, the number of newly defined block techniques is daily increasing like M-TAPA and SE-TAP block.

The rectus sheath block (RSB) is an old technique that suite midline incisions and provides analgesia for somatic pain. The local anesthetic is injected into the space between the posterior wall of the rectus abdominis muscle and its sheath, to block the anterior branches of the thoracoabdominal nerves. It has been suggested that both anterior and lateral branches of the T5-T12 thoracoabdominal nerves are blockade in M-TAPA and SE-TAP blocks. So, they may provide better analgesia and quality of recovery for major abdominal surgeries due to presence of drains. However, the extent of the local anaesthetic diffusion and the dermatomal levels are not clear, and there is no randomised clinical trial about these new techniques, to our knowledge.

Patients and Methods: This is a prospective, randomised, double-blind clinical study; carry out on 120 patients schedule for elective major abdominal surgery with midline incision. While the fascia is closed, 1 g paracetamol and 1 mg/kg tramadol will be administered routinely to all patients for postoperative multimodal analgesia. At the end of surgery, patients will be randomly allocated into three groups (40 patients each); bilateral SE-TAP block in Group S, bilateral RSB in Group R, and bilateral M-TAPA block in Group M will be performed under ultrasound guidance. Patient controlled analgesia with intravenous morphine will be started at the recovery room. Postoperative pain levels, opioid consumption, and quality of recovery will be questioned and recorded at the first postoperative day.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology physical classification I-III
  • Scheduled for elective laparotomy with a midline incision

排除标准

  • Not agree to participate in the study
  • Have mental status disorders
  • Inability to communicate
  • Known bleeding and/or coagulation disorders
  • Infection at injection site
  • Chronic opioid intake

结局指标

主要结局

Quality of Recovery

时间窗: At postoperative 24th hours

Quality of Recovery-40 (QoR-40), a 40-item questionnaire that provides a global score and subscores across five dimensions; patient support, comfort, emotions, physical independence, and pain (minimum score of 40 and maximum of 200).

次要结局

  • Postoperative pain(At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours))
  • Opioid consumption(At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulay ERDOGAN KAYHAN

Professor

Inonu University

研究点 (2)

Loading locations...

相似试验