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临床试验/NCT05549492
NCT05549492已完成1 期

Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021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
1 期
状态
已完成
入组人数
64
试验地点
1
主要终点
Post Operative Pain

研究概览

简要总结

Buprenorphine intravenous, sublingual, and transdermal patches have been researched for their antihyperalgesic effects, although peripherally mediated effects have not been examined in Egypt surprisingly

详细描述

This prospective, randomized, double-blind controlled trial involved 88 patients who were scheduled for inguinal hernia surgery followed by a TAP block. Patients were allocated into group B (n= 44) received 20 ml of 0.25% Ropivacaine for TAP block; group BR (n= 44) received 20 ml of 0.25% Ropivacaine containing 300 μg of buprenorphine for TAP Block. The primary outcome of the study was the analgesic and antihyperalgesic effect of buprenorphine compared to the control group. The duration of analgesia, analgesic consumption, postoperative pain scores at rest and sitting up to 48 hrs, and effect on wound hyperalgesia at 24 and 48 hrs were evaluated. Secondary outcomes of the study include incidence of side effects and TAP block-related complications were recorded. Effect of buprenorphine on patients with predicted high pain scores and incidence of persistent postoperative pain were also determined.

A transversus abdominis plane (TAP) block provides analgesia of the anterior and lateral abdominal wall below the umbilicus by blocking the T6-L1 segmental nerves as they lie within the fascial plane between the transversus abdominis and internal oblique muscles: bilateral block for midline abdominal incision. It was first described in 2001 by Rafi as a traditional blind landmark technique using the lumbar triangle of Petit. Local anesthetic is then injected between the internal oblique and transverse abdominis muscles just deep the fascial plane, the plane through which the sensory nerves pass

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
Single (Participant)

入排标准

年龄范围
30 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Inguinal Hernia
  • Medically free

排除标准

  • participants with a history of heart, renal and liver cell failure.
  • allergic reaction to studied drugs, and history of epilepsy,
  • hydrodynamic instability,
  • chronic pain.
  • mental illness.

研究组 & 干预措施

Group B

Experimental

Candidates received 20 ml of 0.25% ropivacaine for TAP block

干预措施: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution (Drug)

Group RB

Experimental

Candidates received 20 ml of 0.25% ropivacaine and 300 μg of buprenorphine, respectively, for the TAP block.

干预措施: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution (Drug)

结局指标

主要结局

Post Operative Pain

时间窗: 2 hours after the operation upto 48-hour analgesic after surgery

The pain level of the cases is evaluated by means of the digital pain as the 11-point visual analog scale (VAS) whereas 0-Represents no pain, 10 - Worst imaginable pain), as well as the 11-point VAS-A (0-Represents no anxiety, 10 - Highest anxiety)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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