跳至主要内容
临床试验/NCT02447965
NCT02447965终止不适用

Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions: A Prospective Randomized Double-Blind Placebo Controlled Study

University of Arkansas1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
Total consumption of nondepolarizing muscle relaxants used during abdominal surgery.

研究概览

简要总结

The purpose of this study is to show that the use of preoperative rectus sheath blocks can ultimately alleviate the need for using nondepolarizing muscle relaxants during certain abdominal procedures.

详细描述

The patients in the active group will be taken to the operating room and standard american society of anesthesiologists monitors will be applied. After induction of general anesthesia, the ultrasonographic anatomy of the umbilical region will be studied in each patient. The probe will be adjusted until optimum view of both rectus abdominis muscles, their sheaths and surrounding structures are identified. Once the umbilical region anatomy has been identified the puncture sites will be determined. The puncture sites will be aseptically prepped, the ultrasound probed will be covered with a sterile tegaderm, and sterile ultrasound gel will be used on the field. A 21-g EchoStim echogenic needle will be used. The needle will be inserted in the long axis parallel to the ultrasound probe. The needle will be advanced carefully until the needle tip is seen between the posterior aspect of the rectus muscle and its sheath. After a confirmed negative aspiration, 15 ml of 0.25% bupivacaine will be inserted in 2 ml increments, aspirating in between.

The placebo group will have the exact same procedure performed except 15 ml of normal saline will be injected in each rectus sheath instead of 0.25% bupivacaine. For all patients, when the block has been completed the surgery team will then prep the patient and proceed with the planned operation. The surgery staff and anesthesia providers taking care of the patient in the operating room will be unaware of the patient's group. At this point, all patients will be treated exactly the same. For intubation purposes, all patients will only receive succinylcholine. After intubation, elimination of the succinylcholine dose will be determined using a twitch monitor on the ulnar nerve. If at any point during the surgery, the surgery team needs more muscle relaxation then the anesthesia staff will give appropriate medications.

The first step will be to administer propofol 50mg IV, if hemodynamics allow, and to verify that the patient has 1.0-1.2 minimum alveolar concentration (MAC) of volatile anesthetic. If the patient is not at 1.0 MAC, then the volatile anesthetic should be increased. If this does not provide sufficient relaxation, then a nondepolarizing muscle relaxant will be given in 10mg increments titrated to a train of four of 2 twitches at the ulnar nerve. All patients will receive ofirmev and fentanyl in the operating room for pain control. Ofirmev 1000mg will be given pre-incision to each patient and 1.5 mcg/kg loading dose of fentanyl will be given to each patient. Fentanyl will be redosed in 50mcg increments for a 20% increase in blood pressure or heart rate above preinduction values that is sustained for 5 minutes despite an adequate depth of anesthesia, defined as 1 MAC or greater.

研究设计

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

入排标准

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

入选标准

  • Scheduled to undergo an abdominal procedure with a periumbilical or midline incision above the umbilicus
  • Age ≥ 18 years.
  • American Society of Anesthesiologists physical status class 1 to 3

排除标准

  • Known coagulopathy
  • Preexisting muscular disease
  • Medical conditions contraindicated to bupivacaine, succinylcholine or other medication used in the study

研究组 & 干预措施

Bupivacaine

Active Comparator

Will have 20ml of bupivacaine injected into each rectus sheath.

干预措施: Bupivacaine (Drug)

Normal Saline

Placebo Comparator

Will have 20ml of normal saline injected into each rectus sheath.

干预措施: Normal Saline (Drug)

结局指标

主要结局

Total consumption of nondepolarizing muscle relaxants used during abdominal surgery.

时间窗: The duration of study therapy is only for the perioperative preparation period (usually 4-5 hrs) for the subject's abdominal procedure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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