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临床试验/CTRI/2019/05/019255
CTRI/2019/05/019255尚未招募不适用

ASSESSMENT OF THE POSTOPERATIVE ANALGESIC EFFICACY OF DEXMEDETOMIDINE AS AN ADJUVANT TO ROPIVACAINE IN TRANSVERSUS ABDOMINIS PLANE BLOCK FOR INFRAUMBILICAL SURGERIES

Dr Bhabesh Prasad Panda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年5月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the duration of postoperative analgesic effect between ropivacaine alone and ropivacaine with dexmedetomidine in ultrasound guided transverse abdominis plane block.

研究概览

简要总结

SUMMARY

Assessment of the postoperative analgesic efficacy of Dexmedetomidine as an adjuvant to Ropivacaine in Transversus Abdominis Plane Block for infraumbilical surgeries

Candidate: Bhabesh Prasad Panda

AIMS AND OBJECTIVES:

To compare and evaluate the analgesic effect of dexmedetomidine 0.5 mcg/kg as an adjuvant to 0.25% ropivacaine  vs 0.25% ropivacaine alone in transverses abdominis plane block in infraumbilical surgeries with regards to duration of analgesia and postoperative analgesic consumption in 24 hours.

MATERIALS AND METHODS:

The present study will be conducted in a randomized manner in the department of Anesthesiology, GGS Medical College and Hospital, Faridkot.

Inclusion criteria: 1.) American Society of Anesthesiologist (ASA) grade I  and II. 2.) Patients aged between 18-65 years. 3.) Patients undergoing infraumbilical surgeries like hernia repair, mesh hernioplasty, appendicectomy under spinal anesthesia.

Exclusion criteria: 1.) Patients with any contraindication to regional anesthesia or allergy to the study drugs. 2.) ASA-III &ASA-IV patients. 3.) Pregnant or lactating patients. 4.)Patient refusal.

A total of 60 patients will be randomly allocated into 2 study groups i.e RS and RD of 30 patients each using computer generated randomization. Patient will be anesthetized with spinal anesthesia by giving 3ml of 0.5% heavy bupivacaine. Group RS will receive 20 ml drug volume of 0.25% ropivacaine + 1 ml of NS and Group RDwill receive 20 ml drug volume of 0.25% ropivacaine + 0.5 mcg/kg dexmedetomidine in US guided TAP block. Duration of postoperative analgesia and total analgesic consumption in first 24 hours postoperatively will be noted and compared. After completion of the study, observations obtained will be tabulated and analyzed using appropriate statistical methods. P value <0.05 will be taken as significant and <0.001 will be taken as highly significant.

This study will help to establish a better post operative pain management protocol in our institute in infra umbilical surgeries.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) grades I and II.
  • Male or female aged 18-65 years.
  • Patients undergoing infraumbilical surgeries like hernia repair, mesh hernioplasty, appendicectomy under spinal anesthesia.

排除标准

  • Patients with any contraindication to regional anesthesia like- 2) Patient’s refusal for TAP block.
  • Patients with local skin infection.
  • ASA-III & ASA-IV 5) Obese patients with BMI >30 kg/m
  • Patients with a history of anaphylaxis to local anesthetics and allergy to the study drugs.
  • Pregnant or lactating patients.
  • Patients with a history of underlying psychological disorder.

结局指标

主要结局

To compare the duration of postoperative analgesic effect between ropivacaine alone and ropivacaine with dexmedetomidine in ultrasound guided transverse abdominis plane block.

时间窗: 12 Months

次要结局

  • To compare quality of analgesia and total postoperative analgesic consumption in 24 hours between ropivacaine alone and ropivacaine with dexmedetomidine in ultrasound guided transverse abdominis plane block.(12 months)

研究者

发起方
Dr Bhabesh Prasad Panda
申办方类型
Other [self]

研究点 (1)

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