跳至主要内容
临床试验/CTRI/2024/04/065824
CTRI/2024/04/065824尚未招募Phase 3 4

Novel vs Traditional : Comparison of 4-l block vs epidural for post operative analgesic needs in knee and below knee surgeries

MMI Narayana superspecialty Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1)Duration of post-operative analgesia.

研究概览

简要总结

THESIS TITLE-

Novel vs Traditional :  comparison of 4-1 block vs epidural for post operative analgesic needs in knee and below knee surgeries.

Knee and below knee surgeries are associated with moderate to severe pain postoperatively leading to delayed recovery and  prolonged hospital stay. Therefore, this study is to compare two types of analgesia. Aim of our study is to compare post-operative analgesia and motor performance between 4-1 Block versus Continuous Epidural Block (CEB) in patients undergoing Knee and below Knee surgeries. Patient will be evaluated on primary outcomes such as duration of post-operative analgesia, total dose of rescue analgesic required in first 24 hours, VAS (Visual Analog Scale) score at  2, 4, 6, 12, 24 hours post-operatively .The secondary outcomes will be to analyze the incidence of complications if any, to assess the side effects of drug used and length of hospital stay. Total 80 patients will be taken and they will be divided randomly into 2 group of 40 each.

Group A-  4-1 BLOCK GROUP : After surgery, supine position is maintained and the vastus medialis muscle is identified by ultrasound. Then scanned proximally till the intersection of vastus and sartorius. Then the probe is slid proximally till the superficial femoral artery appears in the adductor hiatus.. The probe is then again slid slowly proximally till the descending genicular artery , a branch from superficial femoral artery is visualised in the adductor hiatus. Further proximally where descending genicular artery disappears is the point of injection. The point is 8-10 cm above the femoral condyle. Under all aseptic precautions, a 22 gauge, 360 ultrasound compatible 100 mm needle is guided in plane from lateral to medial side under ultrasound guidance to reach perivascular regions and after negative aspiration , 0.2% ropivacaine 35 ml along with 0.5 mcg/kg Dexmedetomidine is injected that is visualised to push the femoral artery posteriorly.

Group B- EPIDURAL BLOCK GROUP : Non ultrasonographic guided Epidural block with bolus dose of 5ml 0.2% Ropivacaine with  0.5mcg/kg Dexmedetomidine will be given followed by the same dose and concentration of the drug as Continuous Epidural Block infusion at rate of 5ml/hour.

After the blocks, vital parameters will be monitored and recorded. Side effects will be observed, if any. Visual Analogue Scale score will be noted at 2, 4, 6, 12 & 24 hours. Length of hospital stay after the surgery will be noted. All the data will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 and ASA 2.

排除标准

  • ASA 3 & 4 Refusal of consent psychological and neurological disorder coagulation disorder infection at local site of injection history of allergy to LA.

结局指标

主要结局

1)Duration of post-operative analgesia.

时间窗: 2, 4, 6, 12, 24 hours

2)Total dose of rescue analgesic required in first 24 hours.

时间窗: 2, 4, 6, 12, 24 hours

3)VAS (Visual Analog Score) in 2, 4, 6, 12, 24 hours post-operatively.

时间窗: 2, 4, 6, 12, 24 hours

次要结局

  • 1)To analyze the incidences of complications, if any, associated with 4 in 1 block and Epidural Blocks(2)To assess the side effects of drugs used in the study)

研究者

发起方
MMI Narayana superspecialty Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Suprava Kundu

NH MMI Superspecialty Hospital

研究点 (1)

Loading locations...

相似试验