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临床试验/NCT03088371
NCT03088371已完成不适用

Psoas Sciatic Blockade Could be a Sole Anaesthetic Technique for Total Knee Arthroplasty

Menoufia University0 个研究点目标入组 80 人开始时间: 2014年4月10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
状态
已完成
入组人数
80
主要终点
Duration of sensory block

研究概览

简要总结

Objectives: To compare the efficacy of continuous combined psoas sciatic block as a sole anaesthetic technique with conventional combined spinal epidural anesthesia for patients undergoing total knee arthroplasty.

Subjects and Method: Eighty patients ASA (American society of anaesthesiologists classification) I to III with age range from 50 to 65 years old and scheduled for total knee replacement were included in the study. Subjects were divided into two groups; the first group (Pso/sci) received ultrasound guided with the use of nerve locator continuous psoas sciatic block and the second group (CSE) received combined spinal epidural anesthesia. Onset of sensory and motor block time, hemodynamic changes, contra-lateral spread, first time need for analgesia, incidence of complications, and patient and surgeon satisfactions were recorded.

详细描述

After approval of the ethics committee, department of anaesthesia, Menoufia university and written informed consent, 80 patients undergoing unilateral total knee arthroplasty were randomly allocated into two groups. The first group (40 patients) received continuous psoas compartment block combined with continuous sciatic block (Pso/Sci group) and the second group (40 patients) received combined spinal epidural anaesthesia (CSE group). All patients were between 50 and 65 years old with an American society of anaesthesiologists classification (ASA status) of I to III. Patients' exclusion criteria included contraindication of regional anesthesia, bleeding disorders, localized infection, neurological deficit, substance dependence, and uncooperative patients. Upon arrival to the operative theater patients were attached to the standard monitoring and an intravenous cannula was inserted. All patients received 1 - 2 mg midazolam for sedation before the blocks.

Sciatic nerve blockade:

The block was done under complete aseptic technique. The patient was positioned in the lateral recumbent position with the operative side up and the hips and knees were flexed. The greater trochanter, posterior superior iliac spine and sacral hiatus were palpated and marked. Curvilinear low frequency U/S probe 2-5 MHz, (Sonosite, M-Turbo, Sonosite Inc., USA) was used for scanning. The probe was placed transversely in the middle of the line connecting the greater trochanter and sacral hiatus. The hip joint and the ischial spine were seen as hyperechoic lines in the lateral and medial sides respectively and the sciatic nerve was appeared as a triangular or flattened hyperechoic structure under the gluteus maximus. Local infiltration with 1 ml lidocaine 2% with 27-gauge needle was done before introducing the 100 mm 18 gauge sterile insulating pajunk needle (PAJUNK, PlexoLong, Germany) for the block.

The pajunk needle was connected to a nerve stimulator (Plexygon, Vygon Italia, Padua, Italy) with 0.8 mA initial current and inserted out of plane reaching the sciatic nerve until eliciting either planter flexion or dorsiflexion with reduced current output up to 0.2 mA. A mixture of 15 ml lidocaine 1% and 15 ml bupivacaine 0.25% were injected around the sciatic nerve. A multi-perforated reinforced catheter was inserted through the needle and advanced 5 cm distal to the needle tip to provide continuous infusion. The needle was removed and the catheter was fixed to the skin.

Psoas compartment blockade:

研究设计

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

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing total knee arthroplasty with ASA I, II, or III.

排除标准

  • Patients refusal, allergy to drugs used, and uncooperative patients.

研究组 & 干预措施

Psoas Sciatic blockade

Other

Psoas Sciatic blockade with 20 ml lidocaine 1% and 20 ml bupivacaine 0.25% pajunk needle used for the block and 5 ml Lidocaine 2% used for post-operative pain.

干预措施: Bupivacaine 0.25% (Drug)

Psoas Sciatic blockade

Other

Psoas Sciatic blockade with 20 ml lidocaine 1% and 20 ml bupivacaine 0.25% pajunk needle used for the block and 5 ml Lidocaine 2% used for post-operative pain.

干预措施: Pajunk Needle (Other)

Psoas Sciatic blockade

Other

Psoas Sciatic blockade with 20 ml lidocaine 1% and 20 ml bupivacaine 0.25% pajunk needle used for the block and 5 ml Lidocaine 2% used for post-operative pain.

干预措施: Lidocaine 1% (Drug)

Psoas Sciatic blockade

Other

Psoas Sciatic blockade with 20 ml lidocaine 1% and 20 ml bupivacaine 0.25% pajunk needle used for the block and 5 ml Lidocaine 2% used for post-operative pain.

干预措施: Lidocaine 2 % (Drug)

Combined spinal epidural

Other

Spinal anaesthesia with 2.5 ml (12.5 mg) of heavy Bupivacaine 0.5%. Epidural for post-operative pain with Bupivacaine 0.125 %in a rate of 7-10 ml/hour Portex combined spinal epidural kit needle through needle.

干预措施: Portex combined spinal epidural kit (Other)

Combined spinal epidural

Other

Spinal anaesthesia with 2.5 ml (12.5 mg) of heavy Bupivacaine 0.5%. Epidural for post-operative pain with Bupivacaine 0.125 %in a rate of 7-10 ml/hour Portex combined spinal epidural kit needle through needle.

干预措施: Bupivacaine 0.5% (Drug)

Combined spinal epidural

Other

Spinal anaesthesia with 2.5 ml (12.5 mg) of heavy Bupivacaine 0.5%. Epidural for post-operative pain with Bupivacaine 0.125 %in a rate of 7-10 ml/hour Portex combined spinal epidural kit needle through needle.

干预措施: Lidocaine 2 % (Drug)

Combined spinal epidural

Other

Spinal anaesthesia with 2.5 ml (12.5 mg) of heavy Bupivacaine 0.5%. Epidural for post-operative pain with Bupivacaine 0.125 %in a rate of 7-10 ml/hour Portex combined spinal epidural kit needle through needle.

干预措施: Bupivacaine 0.125 % (Drug)

结局指标

主要结局

Duration of sensory block

时间窗: 24 hours post-operative.

Duration of the sensory block is the time from the onset of the block to the first call of analgesia (minutes).

次要结局

  • Mean arterial blood pressure(Intra-operative)
  • Surgeons' satisfaction questionnaire(Peri-operative)
  • Heart rate(Intra-operative.)
  • Time of mobilisation(24 hours post-operative.)
  • Patients' satisfaction questionnaire(Peri-operative)

研究者

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

Dr Ezzeldin Ibrahim

Assistant Professor in anaesthesia, intensive care, and pain medicine.

Menoufia University

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