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临床试验/CTRI/2018/04/013131
CTRI/2018/04/013131已完成不适用

Comparison between ropivacaine 0.5% and bupivacaine 0.5% in ilioinguinal-iliohypogastric nerve block for Inguinal Hernia Repair- A prospective randomised double blind study

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年10月9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
70
试验地点
1
主要终点
To evaluate the efficacy of single-puncture technique of local anaesthesia for inguinal hernia repair.

研究概览

简要总结

Purpose:

I.              I.            To compare 0.5% bupivacaine with 0.5% ropivacaine, both in combination with 2% lignocaine-adrenaline regarding efficacy, safety and duration of post-operative analgesia in the patients undergoing unilateral inguinal hernia repair.

II.            To document complications, if any.

Results were as follows:

1.    The mean age of patients in our study was 48.6±15.56 years in Group LB and 46.48±14.03 years in Group LR.

2.    The mean weight (kg) of the patients in Group LB was 62.91±6.89 and in Group LR was 61.71±6.44.

3.    In Group LB, 25 (71.42%) patients belonged to ASA grade I, 10 (28.57%) belonged to ASA grade II and none to ASA grade III. While in Group LR, 27 (77.14%) patients were of ASA grade I, 8 (22.85%) were of ASA grade II and none in ASA grade III.

4.    In Group LB, 13 (37.14%) patients had hernia on the right side and 22 (62.85%) on the left side as compared to Group LR where 17 (48.57%) patients had hernia on the right side and 18 (51.42%) on the left side.

5.      In group LB, the onset was earlier (10.15±1.49 min) as compared to Group LR (11.4±1.71 min).

6.      Duration of surgery in Group LB was 59.34±10.90 min and in Group LR was 61.22±11.02 min.

7.      Preoperative VAS score was less in group LB (0.64±0.54) as compared to Group LR (0.77±0.49). VAS at the time of shifting was found to be more in Group LB (0.94±0.53) than in Group LR (0.91±0.50) patients.

8.      Seventeen (48.57%) patients in Group LR required infiltration of sac as compared to three (8.57%) in Group LB.

9.      Duration of analgesia was significantly longer in Group LR (481.71±70.52 min) as compared to Group LB (236.57±35.5 min).

10.  There was no statistically significant difference in haemodynamic parameters of HR, SBP, DBP and MAP of two groups at any given time.

11.  No complications related to the procedure or drugs were observed in our study.

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 80.00 Year(s)(—)
性别
Male

入选标准

  • ASA Grade I, II and III 2)scheduled for uncomplicated inguinal hernia repair.

排除标准

  • Patient refusal 2)Patients with known hypersensitivity to local anaesthetics 3)Patients with ASA grade IV or more 4)Paediatric age group (<18 years) 5)Morbid obesity (BMI >35kg/m2) 6)Complicated hernias such as irreducible, strangulated, incarcerated or recurrent hernia.

结局指标

主要结局

To evaluate the efficacy of single-puncture technique of local anaesthesia for inguinal hernia repair.

时间窗: 1 year

次要结局

  • To compare 0.5% bupivacaine with 0.5% ropivacaine, both in combination with 2% lignocaine-adrenaline regarding efficacy, safety and duration of post-operative analgesia in the patients undergoing unilateral inguinal hernia repair.(1 year)

研究者

发起方
Department of Anaesthesiology
申办方类型
Government medical college

研究点 (1)

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