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临床试验/NCT03155568
NCT03155568Unknown不适用

Safety and Efficacy of Single Ankle, Single Popliteal or Combined Ankle and Popliteal Block for Diabetic Foot Surgery: A Comparative Study

Assiut University0 个研究点目标入组 90 人开始时间: 2017年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
90
主要终点
failure rate

研究概览

简要总结

Diabetic patients suffering diabetic foot disease have sever comorbidities, as hypertension, ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which contribute to a high risk profile for anesthesia.

failure rate associated with ankle or popliteal nerve block may be higher than accepted, the study hypothesized that combined ankle and popliteal block may increase the success rate with no added complications.

详细描述

Diabetic patients suffering diabetic foot disease regularly have sever co-morbidities, they are more liable to hypertension, ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which contribute to a high risk profile for anesthesia according to American society of anesthesiologists patients classification.

Anesthetic management for diabetic foot disease surgery is a frequent challenge and should be undertaken with a careful consideration of the anesthetic techniques available.

Hazards of general anesthesia is more likely in diabetic patients as they have low reserves to preserve against additional straining factors during general anesthesia consequently, avoiding general anesthesia in this population may be a central concern to ensure optimal peri-operative management following lower limb surgery. Neuraxial anesthesia is complicated by urinary retention, hypotension and postdural puncture headache and backache. In chronic ischemic legs, with multiple and diffuse stenosis in the leg segmental vessels, hypotension can precipitate thrombosis easily. In addition fluid loading and vasopressor administration may not be ideal methods to treat hypotension since end stage renal disease and coronary artery occlusive disease are common in these patients.

Relative to central nerve block, peripheral limb blocks are more discriminatory in their action and consequently result in less interference of bladder function and motor impairments. Also with peripheral nerve block, patients do not require postoperative fasting that help in preserving patient glycemic control. Moreover. Nerve block anesthesia has the advantages of improved postoperative pain control and it is more economical reducing hospital and associated expenses.

Ankle block alone has high failure rate and require more than usual dose to get effective. In popliteal block larger dose is needed than ankle and there is more time delay. The investigators thought to get the advantages of using local than general anesthesia with combined ankle and popliteal blocks to increase potentiation and decrease doses in diabetic foot surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) II and III
  • Co-operative
  • Diabetic patients
  • Scheduled for various types of elective diabetic unilateral foot operations

排除标准

  • Patients suffering psychiatric neurological or neuromuscular disorders.
  • Allergy to local anesthetics used.
  • Infection at the block site.
  • Sever renal and hepatic impairment.
  • Patients receiving chronic analgesic therapy.

研究组 & 干预措施

sciatic nerve block

Active Comparator

ultrasound guided sciatic nerve block by injecting 30ml of 0.5% bupivacaine and visualized circumferentially spreading around the sciatic nerve

干预措施: sciatic nerve block (Procedure)

sciatic nerve block

Active Comparator

ultrasound guided sciatic nerve block by injecting 30ml of 0.5% bupivacaine and visualized circumferentially spreading around the sciatic nerve

干预措施: Bupivacaine (Drug)

ankle block

Active Comparator

ankle block performed by injecting 20 ml of 0.5% bupivacaine in equal amounts around the five major nerves supplying the foot

干预措施: ankle block (Procedure)

ankle block

Active Comparator

ankle block performed by injecting 20 ml of 0.5% bupivacaine in equal amounts around the five major nerves supplying the foot

干预措施: Bupivacaine (Drug)

combined popliteal and ankle block

Active Comparator

combined block performed by the use of 20 ml of 0.25% bupivacaine for sciatic nerve block followed by the ankle block with use of 20 ml of 0.5% bupivacaine both in the same manner as other two groups.

干预措施: sciatic nerve block (Procedure)

combined popliteal and ankle block

Active Comparator

combined block performed by the use of 20 ml of 0.25% bupivacaine for sciatic nerve block followed by the ankle block with use of 20 ml of 0.5% bupivacaine both in the same manner as other two groups.

干预措施: ankle block (Procedure)

combined popliteal and ankle block

Active Comparator

combined block performed by the use of 20 ml of 0.25% bupivacaine for sciatic nerve block followed by the ankle block with use of 20 ml of 0.5% bupivacaine both in the same manner as other two groups.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

failure rate

时间窗: from the time of randomization until 5 days postoperatively

number of patients converted to general anesthesia

次要结局

  • duration of sensory block(from the time of randomization until 5 days postoperatively)
  • Duration of motor blockade(from the time of randomization until 5 days postoperatively)
  • The onset of sensory block(from the time of randomization until 5 days postoperatively)
  • The onset of motor block(from the time of randomization until 5 days postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdel-Baky Abdel-Rahman

lecturer of anesthesia and intensive care

Assiut University

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