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临床试验/NCT04993521
NCT04993521已完成不适用

Ultrasound Guided Bilateral Superficial Cervical Plexus Block Versus Local Wound Infiltration in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Study

University Hospital, Linkoeping2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
postoperative opioid consumption in the first postoperative day

研究概览

简要总结

The present study compared the efficacy of bilateral superficial cervical plexus block (BSCPB) versus local wound infiltration (LWI) regarding the postoperative opioid consumption in patients undergoing total thyroidectomy

详细描述

We performed a double-blind, randomised, controlled trial that recruited patients undergoing total thyroidectomy at the Suez Canal University Hospital during the period between February 2019 and January 2021. Patients were eligible if they were older than 20 years, had an American Association of Anesthesiologists' (ASA) level of I-II, and were scheduled for total thyroidectomy. We excluded patients with documented allergies to the study's intervention materials, moderate-to-severe obesity, > 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies. All patients were required to fill out informed consent before enrollment.

Eligible patients were randomly allocated in a 1:1 ratio to receive BSCPB or LWI using the computer software program (www. Randmizer.org) and allocation sequences were done using opaque, closed envelopes. The BSCPB group received BSCBP (after general anaesthesia but before the start of surgery) from two syringes containing ropivacaine 0.5 % and LWI with saline. The LWI group received LWI with ropivacaine 0.5% and the BSCPB from two syringes containing saline.

The primary outcome of the present study was postoperative opioid consumption in the first postoperative day. The secondary outcomes included the total intraoperative fentanyl and isoflurane consumption, time to first required analgesic, and VAS during the first 24 hours postoperatively.

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
None

入排标准

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

入选标准

  • ASA I-II, and were scheduled for total thyroidectomy

排除标准

  • documented allergy to study's intervention, moderate-to-severe obesity, > 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies.
  • All patients were required to fill the informed consent before enrollment.

结局指标

主要结局

postoperative opioid consumption in the first postoperative day

时间窗: 24 hours

postoperative opioid consumption in the first postoperative day in milligrams

次要结局

  • time to first required analgesic(6 hours)
  • total intraoperative fentanyl (mg) and isoflurane consumption (ml)(6 hours)
  • VAS (10 cm; range): Pain average (VAS) for the first 24 hours postoperatively(every 6 hours until 24 hours postoperatively)

研究者

发起方
University Hospital, Linkoeping
申办方类型
Other
责任方
Principal Investigator
主要研究者

Folke Sjoberg

professor

University Hospital, Linkoeping

研究点 (2)

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