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临床试验/CTRI/2022/08/044592
CTRI/2022/08/044592尚未招募2/3 期

Comparative Study Of Tramadol And Butorphanol As Adjuvants To Levobupivacaine In 3 In 1 Block For Post Operative Analgesia In Fracture Femur Surgeries

Sri Guru Ram Dar Institute of Medical Sciences Research1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年8月8日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare the duration of post operative analgesia using preemptive ultrasound guided three in one block using

研究概览

简要总结

Postoperativepain is often undertreated. Safe and effective pain management should be theprimary goal to improve patient rehabilitation and satisfaction. Post operativepain relief can be achieved by a variety of techniques including parentalNSAIDS (non-steroidal anti-inflammatory drugs), opioids, epidural analgesia,patient controlled analgesia and peripheral nerve blocks. Three in one femoralnerve block is relatively simple to perform, effective, low risk technique witha high success rate.

The 90 patients ASA grade I-II in age group 18-80years undergoing fracture femur surgery at SGRD Amritsar will be studied withthe aim of evaluating the effectiveness of addition of tramadol or butorphanolas adjuvants to levobupivacaine vs levobupivacaine and saline through 3 in 1femoral nerve block randomly divided into 3 groups with 30 patients eachreceiving preemptive three in one nerve block either using 0.25%Levobupivacaine alone (Group I) or tramadol 1mg/kg (Group II) or butorphanol 0.06mg/kg as adjuvant to 0.25% levobupivacaine (Group III). To every patientspinal anaesthesia using 0.5% heavy bupivacaine will be given. Ease ofpositioning, pain relief, and duration of post operative analgesia in all thethree groups will be compared. In addition, post operative requirement ofintravenous diclofenac 75 mg will be evaluated.

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 80.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I-II undergoing femur fracture surgeries.

排除标准

  • 1.A known history of allergy, sensitivity or any kind of reaction to the drugs used in the study.
  • 2.Contraindication to neuraxial blockade (less platelet count, significant neurological disease, diagnosed increased intracranial pressure, epidural lipomatosis, tumors fracture spine, caudaequina syndrome) 3.Bleeding disorders.
  • 4.Large inguinal lymph nodes or tumor 5.Psychiatric patients/ Unco-operative patients.

结局指标

主要结局

To compare the duration of post operative analgesia using preemptive ultrasound guided three in one block using

时间窗: From the start of the Femoral nerve block to the 24 hrs after surgery

•0. 25% levobupivacaine and normal saline

时间窗: From the start of the Femoral nerve block to the 24 hrs after surgery

•0. 25% levobupivacaineand tramadol

时间窗: From the start of the Femoral nerve block to the 24 hrs after surgery

• 0. 25% levobupivacaine and butorphanol

时间窗: From the start of the Femoral nerve block to the 24 hrs after surgery

次要结局

  • To compare the duration of post operative analgesia using preemptive ultrasound guided three in one block using in terms of ease of positioning, duration of postop analgesia, requirement of rescue analgesia and adverse effects.(From the start of the Femoral nerve block to the 24 hrs after surgery)

研究者

发起方
Sri Guru Ram Dar Institute of Medical Sciences Research
申办方类型
Research institution and hospital

研究点 (1)

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