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临床试验/CTRI/2023/01/048883
CTRI/2023/01/048883尚未招募不适用

A COMPARATIVE EVALUATION OF ULTRASOUND GUIDED CAUDAL BLOCK WITH ROPIVACAINE VERSUS ROPIVACAINE WITH DEXAMETHASONE FOR POST OPERATIVE ANALGESIA IN ADULT PERINEAL SURGERY:A PROSPECTIVE RANDOMISED DOUBLE BLINDED STUDY

TATA MOTORS HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月1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
Duration of analgesia between the 2 groups.

研究概览

简要总结

Caudal epidural block is a commonly used technique for surgical anaesthesia in children and chronic pain management in adults. Using conventional blind technique, the failure rate of caudal epidural block in adults is high even in experienced hands. This high failure rate could be attributed to anatomical variations that make

locating sacral hiatus difficult. With the advent of ultrasonography it has been demonstrated to be highly effective in accurately guiding the needle entering the caudal epidural space and resurgence of interest in caudal block in adult for chronic pain relief and postoperative analgesia.

While excellent pain relief, minimal side effects, and high patient satisfaction are the advantages; short duration after a single injection is the single main disadvantage even with long‑acting local anaesthetics such as bupivacaine.Therefore, various adjuvants like opioids, alpha 2 agonist and steroids have been added to prolong the duration of caudal block. Dexamethasone potentiates analgesia of the caudal block by regulating transcription factor nuclear factor-kB and inhibits central sensitization after surgery. This study is designed to compare the analgesic efficacy of plain 20ml of 0.25% ropivacaine versus dexamethasone 8mg added as an adjuvant to ropivacaine for caudal block in adult perineal surgeries, in terms of the duration of post-operative analgesia, patients satisfaction and any side effects.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor 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

  • 1 Patients informed consent 2 Age of patients 18-70 years 3 Patients undergoing perineal surgery 4 ASA GRADE 1 to 3.

排除标准

  • 1 Patient refusal 2 A history of drug allergy or local anaesthetic systemic toxicity 3 Uncontrolled Diabetes Mellitus 4 Contraindications to caudal block 5 Anatomical abnormality 6 Block failure.

结局指标

主要结局

Duration of analgesia between the 2 groups.

时间窗: Duration of analgesia between the 2 groups.

次要结局

  • Total amount of tramadol consumption.(24 hours.)
  • Pain Score (NRS)(24 hours)
  • Adverse effects and complications(24 hours)

研究者

发起方
TATA MOTORS HOSPITAL
申办方类型
Research institution and hospital

研究点 (1)

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