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临床试验/NCT05767944
NCT05767944已完成不适用

Wide-Awake Local Anesthesia No Tourniquet (WALANT) Versus Regional Anesthesia With Tourniquet for Hand Flexor Tendon Repair Surgeries in Adults

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Intra-operative pain score

研究概览

简要总结

The study trying to fined out the best anaesthesia technique for hand flexor procedures which provide efficient anaesthesia while providing adequate surgical field exposure & less blood loss

详细描述

The current study compared patients scheduled for hand surgical procedures using wide awake local anaesthetic infiltration to those receiving supra-clavicular brachial plexus block. the comparison including adequacy of pain control, blood loss, patient satisfaction, time & skills needed to provide aesthetic technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

For those assessing & providing postoperative analgesia (secondary outcome)they are blind to the used anaesthetic technique .

入排标准

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

入选标准

  • •Participants were included if they were to be scheduled for Flexor tendon repair (Interventions involving flexor tendons of the wrist (Flexor Carpi Ulnaris (FCU), Flexor Carpi Radialis (FCR), and/or Palmaris Longus PL), fingers (flexor digitorum Profundus FDP and/or Flexor Digitorum Superficialis FDS) and thumb (Flexor Pollicis Longus FPL)), aged 18 years or over & of ASA physical status I or II.

排除标准

  • •Participants were excluded if they were (American society of Anaesthesia) ASA physical status III or IV, refusal of anaesthetic procedure or refuse to participation in the study, documented hypersensitivity to lidocaine, compromised peripheral circulation (Patients with previous vascular injury, vasculitis, Buerger's disease, and scleroderma), evidence of infection at injection site, patients with ischemic heart disease or psychiatric illness and patients with concomitant injuries that needed further operative procedure under general anesthesia or spinal anesthesia.

研究组 & 干预措施

Wide Awake Local Anesthesia (WALANT)

Experimental

Study arm: (WALANT) patient received local anaesthesia (25ml of 2%lidocaine with 0.5 ml of adrenaline (1mg/mL) and 5 ml of 8.4% of sodium bicarbonate. the final 50 ml mixture contained 10 mg/ml Lidocaine and adrenaline 1:100,000 concentration) infiltration along rays at site of surgery (15 ml or more per ray (150 mg lidocaine) by 27G needle, 10 ml (or more) in the palm, then 2 ml in the proximal and middle phalanges and 1 ml in the distal phalanx (if required )) for hand flexor tendons repair.

干预措施: local anaesthesia infiltration (Other)

Supra Clavicular- Brachial Plexus Block (SC-BPB)

Active Comparator

Control arm:(SC-BPB): ultrasound-guided injection of local aesthetics (15 mL of 2% lidocaine and 15 mL of 0.5% bupivacaine were injected incrementally over 3-5 min) at supra-clavicular level where brachial plexus trunks are located this will provide anesthesia for the whole upper limb distal to shoulder joint.

干预措施: brachial plexus block (Other)

结局指标

主要结局

Intra-operative pain score

时间窗: duration of operation

pain assessment during operation at the following moments: before the injection, during injections , during the incision , during gentle manipulation , during aggressive manipulation and during wound closure.

次要结局

  • postoperative pain scores(12 hours postoperatively)
  • patient satisfaction(12 hours post operative)
  • Blood loss(duration of operation)
  • anaesthesia induction time(duration of operation)
  • intra-operative preserved motor power intraoperative(duration of operation)
  • operative time(duration of operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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