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临床试验/CTRI/2019/03/018097
CTRI/2019/03/018097已完成不适用

Comparing efficacy of Transversus Abdominis Plane and Ilioinguinal Iliohypogastric nerve blocks for post op analgesia in Inguinal Hernia Surgeries under Sub Arachinoid Block

Dr Anup Gohatre1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年3月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Time of request of first rescue analgesia

研究概览

简要总结

Inguinal hernia repair is commonly performed under spinal anesthesia. Inadequate postoperative analgesia is one of the most common causes of poor patient satisfaction. Abdominal field blocks like Transversus Abdominis Plane (TAP) block and Ilioinguinal-Iliohypogastric nerve (II-IH) blocks, because of technical simplicity, opioid-sparing effects, and prolonged pain relief, are the upcoming promising techniques of management of postoperative pain for lower abdominal surgeries.

This randomized prospective study will be carried out on 80 adult patients of ASA physical status I and II, scheduled for elective open inguinal hernia repair surgeries under spinal anesthesia. After the approval by the institutional Ethical Committee, written informed consent will be obtained from all the patients before being included in the study. They will be randomly allocated to following groups of 40 each: Group TAP: Ultrasound-guided TAP block will be given with 20 ml of 0.25% bupivacaine. Group II-IH: Conventional II-IH block will be given with 16 ml of 0.25% bupivacaine.

Time of return of sensation after weaning of spinal anesthesia and time of request of first rescue analgesia will be recorded in all the patients. Amount of i.v. analgesics used in PACU, POD1, POD2. VAS score at rest (VASr) before discharge from PACU, and 4 and 12 h after surgery and VAS score at rest (VASr) as well as on movement (VASm) on the first postoperative day (POD1) and POD2 will be, and 3 and 6 months after surgery will be obtained. LA complication, if any, and urinary retention and leg weakness will be recorded

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to American Society of Anesthesiologist (ASA) Grade- I & II, Weighing 40 to 80 Kgs, above 18 years of age, of both the sexes and undergoing elective open inguinal hernia repair surgery under spinal anesthesia.

排除标准

  • Patients not giving consent to the study, Age ≤18 yr BMI ≥40 kg m-2 Skin infection at the puncture site Contraindication to LA agents Chronic hepatic or liver failure Preoperative opioid or non-steroidal anti-inflammatory drugs treatment for chronic pain Patient Refusal.

结局指标

主要结局

Time of request of first rescue analgesia

时间窗: At 4hrs, 24hrs and 48hrs.

Amount of IV Diclofenac sodium

时间窗: At 4hrs, 24hrs and 48hrs.

VAS score, at rest, as well as on movement.

时间窗: At 4hrs, 24hrs and 48hrs.

次要结局

  • Complications related with SAB, Urinary retention and leg weakness.(Procedure related complications, such as hematoma, bleeding, loss of sensation and infections.)

研究者

发起方
Dr Anup Gohatre
申办方类型
Other [investigator]

研究点 (1)

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