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临床试验/NCT06628882
NCT06628882已完成不适用

Comparison of Infraclavicular Block and Wide-Awake Local Anesthesia With No Tourniquet for Hand Surgery: A Prospective Randomized Controlled Study

Uludag University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年12月7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
发起方
入组人数
55
试验地点
1
主要终点
the visual analog scale (VAS)

研究概览

简要总结

The patients were randomized into the WALANT and ICB groups. The pain levels of the patients before, during, and after surgery were queried and recorded using the visual analog scale (VAS). Their satisfaction levels were evaluated using a Likert scale. The duration of anesthesia administration, onset of the anesthesia effect, additional intraoperative analgesic needs, total duration of the anesthesia effect, postoperative analgesic needs, length of hospital stay, total surgical duration, hospitalization costs, and complications were evaluated.

详细描述

The inclusion criteria were patients between the ages of 18 and 70, an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III, surgery planned for a single indication, and a surgery duration of between 20 and 60 minutes. The exclusion criteria were patients with an ASA classification >III, patients with planned bilateral surgery, patients with a local infection, patients with a neurological disorder affecting the same upper extremity, patients with a history of allergy to local anesthetic drugs, patients with a history of opioid use in the previous month, and patients who were unable to understand the study and answer the questions adequately.

WALANT: The WALANT solution was prepared as follows: 50 mL of 1 mg/1 mL epinephrine + 2% lidocaine + 39 cc of 0.9% isotonic NaCl + 10 mL of 8.4% sodium bicarbonate [11]. The surgical area was sterilized with polyvinyl iodine. Using a 27-gauge syringe, the solution was applied around the incision site, either from a single point or several different points, until whitening of the skin was observed. Care was taken not to exceed the maximum dose of 7 mg/kg. The surgical procedure began 20-30 minutes after the application of the WALANT technique. Figure 1 shows patients for whom the WALANT technique was administered..

ICB: Patients were placed in the supine position with the head facing the opposite direction of the blocked side .After sterilizing the skin with povidone iodine, a linear ultrasound probe was sterilized and placed vertically over the infraclavicular fossa to visualize the axillary artery and the lateral, medial, and posterior cords of the brachial plexus. Using an 80 mm long 21G Stimuplex1 needle, a mixture of 10 cc 0.5% bupivacaine and 2% lidocaine was injected around the three cords with intermittent aspiration for control purposes. Figure 2 shows patients who underwent the ICB procedure.

Clinical evaluation: Patients who could not achieve sufficient pain control were either sedated or switched to general anesthesia and were excluded from the study. The pain levels of the patients before, during, and after surgery were queried and recorded using the visual analog scale (VAS). The patients were asked whether they would prefer the same anesthesia method if another surgery were planned, and their satisfaction levels were evaluated using a Likert scale, where 1 indicated low levels of satisfaction, and 4 denoted high levels of satisfaction. The duration of anesthesia administration, onset of the anesthesia effect, intraoperative additional analgesic needs, total duration of the anesthesia effect, postoperative analgesic needs, length of hospital stay, total surgical duration, and complications were evaluated. The hospitalization costs (including the cost of drugs and anesthesia materials) of the WALANT and ICB groups were calculated and compared.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiologists (ASA) physical status classification of I, II, or III,
  • •surgery planned for a single indication
  • •surgery duration of between 20 and 60 minutes.

排除标准

  • •patients with an ASA classification >III,
  • •patients with planned bilateral surgery,
  • •patients with a local infection,
  • •patients with a neurological disorder affecting the same upper extremity,
  • •patients with a history of allergy to local anesthetic drugs,
  • •patients with a history of opioid use in the previous month,
  • •patients who were unable to understand the study and answer the questions adequately

研究组 & 干预措施

Infraclavicular Block

Active Comparator

Patients were placed in the supine position with the head facing the opposite direction of the blocked side .After sterilizing the skin with povidone iodine, a linear ultrasound probe was sterilized and placed vertically over the infraclavicular fossa to visualize the axillary artery and the lateral, medial, and posterior cords of the brachial plexus. Using an 80 mm long 21G Stimuplex1 needle, a mixture of 10 cc 0.5% bupivacaine (BUPIVON® liquid 5%, On Pharma, Istanbul, Turkey)and 2% lidocaine(JETOKAIN® liquid Adeka Pharma, Istanbul, Turkey) was injected around the three cords with intermittent aspiration for control purposes.

干预措施: Infraclavicular Block (Procedure)

Wide-Awake Local Anesthesia with No Tourniquet

Experimental

The WALANT solution was prepared as follows: 50 mL of 1 mg/1 mL epinephrine + 2% lidocaine(JETOKAIN® liquid Adeka Pharma, Istanbul, Turkey) + 39 cc of 0.9% isotonic NaCl + 10 mL of 8.4% sodium bicarbonate . The surgical area was sterilized with polyvinyl iodine. Using a 27-gauge syringe, the solution was applied around the incision site, either from a single point or several different points, until whitening of the skin was observed. Care was taken not to exceed the maximum dose of 7 mg/kg. The surgical procedure began 20-30 minutes after the application of the WALANT technique.

干预措施: Wide-Awake Local Anesthesia with No Tourniquet (Procedure)

结局指标

主要结局

the visual analog scale (VAS)

时间窗: after surgery (Day 1)

pain score - (0-10 point - higher scores mean worse)

the visual analog scale (VAS)

时间窗: before surgery

pain score - (0-10 point - higher scores mean worse)

the visual analog scale (VAS)

时间窗: during surgery

pain score - (0-10 point - higher scores mean worse)

次要结局

  • Likert scale(0-5 points)(after surgery (Day 1))
  • Likert scale(0-5 points)(after surgery (Day 0))

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selcan Akesen

Anesthesiology and Reanimation Specialist

Uludag University

研究点 (1)

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