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临床试验/NCT05697276
NCT05697276已完成不适用

Which Combination of Local Anesthesia is Superior for Postoperative Pain After Carpal Tunnel Surgery?: A Prospective Randomized Study.

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年9月13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
82
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

The goal of this clinical trial is to compare the use of bupivacaine and lidocaine as local anesthetics in carpal tunnel release surgery. The main questions it aims to answer are:

  • Are there any differences in pain after surgery?
  • Are there any differences in postoperative analgesic consumption?

详细描述

The Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique has become popular for hand surgery in the past decade. It consists of injecting a local anesthetic and epinephrine into the surgical site. Lidocaine, a short-acting local anesthetic, is used in the classic description. Adding a long-acting local anesthetic, such as bupivacaine, has been suggested for long surgeries.

However, the use of bupivacaine in shorter-duration procedures could combine the advantages of ambulatory surgery without a tourniquet with long-acting analgesia, improving postoperative pain and reducing the consumption of analgesics.

Patients undergoing first-time open carpal tunnel release surgery will be randomized to receive bupivacaine or lidocaine. Randomization will be generated by computer using random block sizes of 2 or 4 with an allocation ratio of 1:1.

Postoperatively, patients will receive standard medical care. It consists of 50 mg of diclofenac to take when they feel pain (with a minimum interval of 8 hours). Patients will be instructed to complete a medication log for pain and analgesic consumption. A blinded investigator will contact them by phone at 24 hours and 48hs. At two weeks, they will be controlled by research staff for complications.

Eighty-two patients will be recruited, 41 per arm, assuming a 20% loss. The sample size was calculated using a 90% power and 5% significance level. The objective was to detect a minimum difference of 2 points on a numeric scale ranging from 0 to 10 with a standard deviation of 2.5 points.

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
Single (Participant)

入排标准

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

入选标准

  • Patients with carpal tunnel syndrome undergoing first-time surgery

排除标准

  • End-stage kidney disease
  • End-stage liver disease
  • Allergy to bupivacaine, lidocaine or diclofenac
  • Carpal tunnel revision surgery
  • Associated surgery (e.g., trigger finger release)
  • Unable to understand informed consent or indications
  • Patients with anxiety related to surgery who explicitly prefer to be sedated or asleep during their surgery
  • Preoperative American Society of Anaesthesiology (ASA) scale ≥3

研究组 & 干预措施

Lidocaine

Active Comparator

Patients will receive lidocaine

干预措施: Lidocaine (Drug)

Bupivacaine

Experimental

Patients will receive bupivacaine

干预措施: Bupivacain (Drug)

结局指标

主要结局

Postoperative Pain

时间窗: Change in pain at 24 and 48 hours or when the patients take analgesics

Visual analog scale, numerical scale from 0 to 10

Time until pain

时间窗: Until 48 hours from surgery

Time in hours (numeric) from surgery until the patient feel pain

Amount of analgesic

时间窗: at 24 and 48 hours

The number of analgesics consumed by the patient. Numeric

次要结局

  • Pain during anesthesia(1 minute after the injection of local anesthesia)
  • interruption of sleep due to pain(at 24 hours)

研究者

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

IGNACIO RELLAN

Principal investigator

Hospital Italiano de Buenos Aires

研究点 (1)

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