跳至主要内容
临床试验/CTRI/2024/07/071473
CTRI/2024/07/071473
尚未招募
4 期

Comparative study of the efficacy of ultrasound guided erector spinae plane block and oblique subcostal transversus abdominis plane block for post operative analgesia after laparoscopic cholecystectomy.A randomized clinical trial

SUBU KOBING1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年8月10日最近更新:

概览

阶段
4 期
状态
尚未招募
发起方
SUBU KOBING
入组人数
86
试验地点
1
主要终点
To evaluate for pain using Numerical Rating Score(NRS)

概览

简要总结

Laparoscopic Cholecystectomy is a minimally invasive surgery, which is the procedure of choice for the majority of patients with gallbladder pathologies. Intraoperative access is provided with small keyhole entries on abdominal wall. Laparoscopic Cholecystectomy causes moderate to severe postoperative pain which has different components; incisional pain from the trocar site(somatic pain),and local visceral pain(deep abdominal pain).Many patients also suffer from shoulder pain which is due to subdiaphragmatic irritation, transmitted by phrenic nerve referred to C4 dermatome. Multimodal approaches with NSAIDS, dexamethasone, gabapentinoids, opioids, local anesthetic infiltration to port sites, epidural analgesia have been tried to attenuate postoperative pain after Laparoscopic Cholecystectomy. Inadequate postoperative pain control has many consequences ,including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, increased healthcare costs etc. Hence, adequate Postoperative Pain Management(POPM) should be major issue and challenge for the anesthesiologists. Ultrasound-guided oblique subcostal transversus abdominis plane block(OSTAP)  blocks somatic pain fibers and the deeper fibers of the anterior and lateral cutaneous branches of the 9th to 11th thoracic intercostal nerves. Ultrasound-guided erector spinae plane block (ESPB) is a relatively new technique used for analgesia. It targets the ventral rami, dorsal rami, and rami communicantes of the spinal nerves and thus results in the blockage of both somatic and visceral pain. Our study aimed to compare these two blocks using low concentration of Local anesthetic (0.25% Levobupivacaine).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients of age 18-70 years with ASA(American Society of Anaesthesiologists)Grade 1 and Grade 2 2.Patients with BMI between 18-30.

排除标准

  • 1.Patients refusal 2.Patients with known allergy to local anaesthesia 3.Patients with bleeding diathesis,presence of severe kidney,hepatic disease,on anticoagulants,pre-existing cardiovascular disease,chronic opioid consumption,severe or advanced psychiatric illness.
  • 4.Patients with previous upper abdominal surgery,any deformity in spine 5.Patients with infection at the regional block site.

结局指标

主要结局

To evaluate for pain using Numerical Rating Score(NRS)

时间窗: Outcome will be assesed at 0 hour,3rd,6th,9th,12th,18th and 24th hour after the intervention

次要结局

  • To evaluate total analgesic consumption and time to first rescue analgesia and postoperative nausea and vomiting(Outcome will be assesed from the time of intervention and data will be collected at the end of 24 hour)

研究者

发起方
SUBU KOBING
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Subu Kobing

RIMS Imphal

研究点 (1)

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