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临床试验/CTRI/2020/02/023230
CTRI/2020/02/023230已完成Unknown

Comparison of analgesic efficacy of two different fascial blocks in patients undergoing laparoscopic inguinal hernia surgery : a randomized controlled trial

Department of Anaesthesia and intensive care1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年2月18日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Postoperative cumulative pain score on movement following blocks

研究概览

简要总结

The present study was conducted in the Department of Anaesthesia and Intensive Care, in collaboration with the Department of Surgery, Government medical college and hospital, Chandigarh. Study has been approved from hospital ethics committee and now registered with CTRI. Informed written consent from 42 patients of either gender, scheduled to undergo laparoscopic inguinal hernia surgery under general anaesthesia after fulfilling inclusion and exclusion criteria will be taken.

Study design: prospective, randomized controlled trial

After the surgery before extubation of trachea patients will be randomised to receive either ultrasound guided transverses abdominis plane block or retrolaminar block. 20ml of 0.375% of ropivacaine will be given on each side. Postoperatively for 24hr patients will followed up for VAS score, total analgesic use, haemodynamics, patient satisfaction score and any other adverse effects. Patients will  be evaluated postoperatively for pain score and patient satisfaction score at 1 month of follow up.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • II Patient scheduled for elective laparoscopic inguinal hernia surgery.

排除标准

  • BMI > 40kg/m2 Coagulopathy Allergic to Ropivacaine, paracetamol and diclofenac Pregnant and lactating women Substance abuse Not able to understand VAS score Contraindication to general anaesthesia or laparoscopic surgery.

结局指标

主要结局

Postoperative cumulative pain score on movement following blocks

时间窗: at 24 hr

次要结局

  • Total dose of rescue analgesic(baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr)
  • VAS score at movement(baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr)
  • Follow up(At 1 month)
  • Time for first use of rescue analgesia(baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr)
  • Haemodynamics (pulse rate, mean arterial pressure, respiratory rate, spo2)(baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr)
  • Patient satisfaction score(24hr)
  • VAS score at rest(baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr)

研究者

发起方
Department of Anaesthesia and intensive care
申办方类型
Government medical college

研究点 (1)

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