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临床试验/NCT03189693
NCT03189693Unknown不适用

Paravertebral Block for Postoperative Pain Management in Adult Patients Undergoing Appendectomy

Makassed General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Analgesic consumption

研究概览

简要总结

Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of appendectomy, somatic PVB has been used for pediatric patients. It was shown to decrease opioid consumption and provide prolonged pain relief. Hence, it would be beneficial to examine the analgesic effect of PVB on appendectomy in adult patients.

详细描述

Patients undergoing appendectomy will be randomly allocated into two equal groups using the sealed envelope technique. All patients will receive general anesthesia (GA). Patients in group I will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture, while patients in Group II will receive placebo.

Paravertebral Block Technique Unilateral right side nerve stimulator-guided PVB is performed while patients are in the left lateral decubitis position. The appropriate levels for the PVB are determined by palpation of the spinous processes. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline. After aseptic preparation of the skin, 1 mL 1% lidocaine is infiltrated at the injection sites. A 21-G nerve stimulation needle (Stimuplex; B. Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to maintain muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA.

4 mL of the local anaesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Older than 18 years
  • Scheduled to undergo appendectomy

排除标准

  • cardiac disease,
  • developmental delay,
  • neurologic deficit,
  • allergies to any of the drugs routinely used in anesthesia management.

结局指标

主要结局

Analgesic consumption

时间窗: 24 hours postoperatively

The quantity of analgesics consumed will be recorded

次要结局

  • hemodynamic stability measured through mean arterial pressure (MAP).(Approximately 1 hour)

研究者

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

Zoher Naja

Chairperson of Anesthesia and Pain Management Department

Makassed General Hospital

研究点 (1)

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