Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block - a Protocol of a Double Blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS)
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and operative methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. Surgery can be performed under axillary or intravenous block, or general anaesthesia. There are no prior randomised controlled trials (RCT) comparing local infiltration anaesthesia to local infiltration anaesthesia augmented with a distal median nerve block in CTR.
The aim of this trial is to investigate whether adding a distal median nerve block to local anaesthesia reduces the patient's perceived pain level for up to 72 hours after CTR, compared to using only local anaesthesia, i.e., an anaesthesia mixture injected solely in and around the planned incision and nerve release. The null hypothesis is that the use of distal median nerve block with local anaesthesia does not reduce pain after CTR compared to pure local anaesthesia.
PERSONNEL (carPal tunnEl ReleaSe lOcal iNfiltratioN mEdian bLockade) is a double-blinded, i.e., patient and investigators, RCT in patients with CTS. Patients will be randomly divided into two parallel trial groups, 1:1 in size to each other. Fifty-nine patients will be needed for each group to have adequate power. The primary outcome is the pain level perceived by the patient after the procedure during the first 72 hours using the Visual Analogue Scale (VAS). Secondary outcomes include patient-rated outcome measures, safety, the entire consumption of pain killers after the surgery during the first 72 hours postoperatively, pain of performing the anaesthesia, and pain during and after the operation.
No trial comparing local anaesthesia to local anaesthesia augmented with distal median nerve block has been published before. There is also no trial noting individual tolerance to pain. The quality of the median nerve block at the wrist has been achieved by using sensory or sensory-motor nerve stimulation and has been proven effective. This increases trust in the effectiveness of the treatment method, but it still needs to be adequately proven which is the goal of this trial.
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, Investigator)
盲法说明
Masking is double blinded (patient and investigators). The trial patients are blinded to the randomization. They can't see to the operation field. In the local anaesthesia group care provider pinches from the area of median nerve blockade prior to performing local anaesthesia.
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
- •≥18 years of age
- •CTS verified by nerve conduction studies
- •Symptoms suitable for CTS
排除标准
- •Recurrent CTS
- •Peripheral neuropathies
- •Known allergy to the trial drugs
- •Profound cognitive impairment
- •Pregnancy
结局指标
主要结局
The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS)
时间窗: Postoperatively during the first 72 hours after the operation
The investigators measure the pain level perceived by the patient after the procedure every fourth hour while awake until third night postoperatively using VAS. The first assessment is performed four hours after the surgery. The mean VAS is calculated from all time points over the 72-hour period. The Visual analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS)
时间窗: Postoperatively during the first 72 hours after the operation
The investigators measure the pain level perceived by the patient after the procedure every fourth hour while awake until third night postoperatively using VAS. The first assessment is performed four hours after the surgery. The mean VAS is calculated from all time points over the 72-hour period. The Visual analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
次要结局
- Total pain during the injection of the anaesthetic solution (VAS)(Immediately after the infiltration of anaesthetic solution)
- Burning pain (VAS)(Immediately after the infiltration of anaesthetic solution)
- Pressure pain (VAS)(Immediately after the infiltration of anaesthetic solution)
- Needle sting pain (VAS)(Immediately after the infiltration of anaesthetic solution)
- Duration of anaesthesia(Postoperatively during the first 72 hours after the operation)
- Self-reported symptom severity and functional status(Before and 3 months postoperatively)
- Worst pain during the operation (VAS)(Immediately after the operation)
- Expected pain (VAS)(Before the infiltration of the anaesthetic solution)
- Patient satisfaction(3 months postoperatively)
- Adverse events (AE)(3 months postoperatively)
- Amount of perceived needle stings(Immediately after the infiltration of anaesthetic solution)
- Consumption of pain killers(Postoperatively during the first 72 hours after the operation)