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临床试验/NCT05995301
NCT05995301已完成不适用

Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery

National Academy of Medical Sciences, Nepal1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月12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
已完成
发起方
入组人数
100
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

The goal of this clinical trial is to compare the postoperative analgesic efficacy of ultrasound-guided TAP block with Local Anesthetic Infiltration of ropivacaine in patients undergoing laparoscopic surgery. The main question it aims to answer is:

• If Transversus Abdominis Plane block with Ropivacaine will produce long duration of analgesia than the Local Anesthetic Infiltration with ropivacaine after laparoscopic abdominal surgery .

详细描述

Pain is a natural phenomenon. Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Pain is distressing and detrimental in post-operative patients. Management of post-operative pain has been a challenge to anesthetists. Pain treatment increase speed of recovery, minimum patient suffering, decrease length of stay, reduced hospital costs, increased patient satisfaction, increase productivity and quality of life.

Peripheral nerve blockade or field block with local anesthesia is helpful in managing postoperative pain effectively whilst avoiding complication associated with intravenous narcotics or neuraxial blockade. Regional block will help in reduction of dose and frequency of intravenous narcotics used in postoperative period, hence minimizing the side effects of narcotics.

Ultrasound guided abdominal nerve blocks are increasingly being used for anaesthesia and analgesia. The Transversus Abdominis Plane (TAP) block is a peripheral nerve block that results in anesthesia of the abdominal wall. This plane represents an anatomical potential space with nerves leaving the plane to innervate the abdominal muscles and skin. Transversus abdominis plane block (TAP block) is a novel procedure to provide postoperative analgesia following laparoscopic surgery.

Ropivacaine has a greater degree of motor sensory differentiation. Ropivacaine has been safely used up to the dose of 200 mg (100 ml of 0.2% ropivacaine) as a field block for post operative analgesia. We are giving a larger volume of ropivacaine (20 ml on each side) expecting to cover the upper abdomen when TAP block is performed via posterior approach.

NULL HYPOTHESIS There is no difference in post operative analgesia with Transversus Abdominis Plane block and local anesthetic infiltration after laparoscopicabdominal surgery

研究设计

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

盲法说明

Patients were randomly assigned to two groups having 50patients in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesia assistant who was not involved in the study.

入排标准

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

入选标准

  • Adult patients of either sex aged 25-70 years
  • ASA physical status I or II
  • Patient posted for elective abdominal laparoscopic surgery.

排除标准

  • Any absolute contraindications to peripheral nerve blockade
  • History of Hypersensitivity to Drugs
  • Uncontrolled Diabetes Mellitus, Renal Failure, Hepatic failure
  • History of neuromuscular or psychiatric disease
  • Patient receiving psychotropic drug, chronic analgesic therapy
  • Patient weight less than 50 kg

研究组 & 干预措施

Group I

Experimental

Transversus Abdominis Plane block

干预措施: Ropivacaine in Transversus abdominis plane (Drug)

Group II

Experimental

Local infiltration

干预措施: Ropivacaine in Local infiltration at port site (Drug)

结局指标

主要结局

Duration of analgesia

时间窗: Time Frame: upto first 24 hour after intervention

Visual analog scale at rest

次要结局

  • Duration of analgesia(Time Frame: upto first 24 hour after intervention)

研究者

发起方
National Academy of Medical Sciences, Nepal
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Surendra Bhusal

Principal Investigator

National Academy of Medical Sciences, Nepal

研究点 (1)

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