aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Total pain level with visual analogic scale (VAS)
研究概览
简要总结
Introduction Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment syndrome in Finland and worldwide. Nowadays carpal tunnel release (CTR) surgery is often done in local anaesthesia. Often the most painful event during CTR is the injection of the local anaesthetic. Multiple different methods have been trialed and buffering the local anaesthetic seems to have good results in reducing the pain caused by the injection. However, no study has buffered long-acting local anaesthetic in CTR surgery, and no study has accounted for the patient's individual pain tolerance in the groups. There are no comparisons of the results to minimal clinically important difference (MCID) for pain.
Hypothesis In this study the investigators will evaluate the effects of buffering long-lasting local anaesthetic in wide-awake local anaesthesia no tourniquet (WALANT) CTR. This study's hypothesis is that buffering long-acting local anaesthetic with sodium bicarbonate decreases the pain of the injection.
The investigators also expect that buffering will reduce the number of needle stings felt during injection, will result in as good perioperative pain control, will lengthen the effect of anaesthetic, will reduce postoperative painkiller usage, will have at least as good functional outcome and greater patient satisfaction.
Methods This study will enlist 116 patients and divide the patients into two groups in this double blinded randomized controlled trial. One group receives non-buffered, and the second group buffered local anaesthetic. This study's primary outcome is to compare burning, pressure, needle sting and total pain the patient experienced between the groups. The investigators will assess this using VAS, and will compare the results to MCID. The investigators secondary outcomes are comparisons of expected injection pain level and pain during CTR with VAS, individual pain tolerance/catastrophising tendency with preoperative PCS-FINv2.0 form, the number of needle stings the patient feels during the injection, functional outcome and improvement of the patients' symptoms with The Boston Carpal Tunnel Questionnaire (Likert 5) before and after the surgery, evaluation of patient satisfaction with net promoter score (NPS) and the use of painkillers, duration of analgesia and pain levels using VAS after the surgery until the 3rd postoperative night.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study nurse prepares the anaesthetic solution in advance, without reporting the contents to the surgeon or assisting nurses. The solution is labelled so that the surgeon doesn't know which solution is used. The used solution is recorded on a data pool and revealed only after the data analysis is made. Neither the investigators or outcome assessors have access to the randomized treatment before data has been analysed.
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
- •Clinically and electrophysiologically diagnosed carpal tunnel syndrome
- •Patients who are scheduled for carpal tunnel release surgery.
排除标准
- •Associated disease or conditions, including earlier injury to median nerve, cervical radiculopathy, cubital tunnel syndrome and other peripheral neuropathy
- •Chronic renal failure
- •Rheumatoid arthritis
- •Allergies to lidocaine
- •Pregnancy
- •Profound cognitive impairment
- •Previous ipsilateral carpal tunnel decompression
研究组 & 干预措施
Non-buffered local anaesthetic
The investigators allocate 58 patients in this arm. It serves as the control group, who receives currently used local anaesthetic solution.
干预措施: Control arm (Other)
结局指标
主要结局
Total pain level with visual analogic scale (VAS)
时间窗: VAS is recorded immediately after the injection of local anaesthetic.
The investigators evaluate the total pain with 0-100 mm visual analogue scale (VAS). In VAS higher number means more pain and is therefore worse. The investigators calculate the mean VAS level for each group and compare the results to find statistically and clinically relevant difference. Clinically relevant difference is evaluated by comparing the VAS difference to MCID.
次要结局
- Pressure pain level with VAS(VAS is recorded immediately after the injection of local anaesthetic.)
- Needle sting pain level with VAS(VAS is recorded immediately after the injection of local anaesthetic.)
- Number of needle stings(Immediately after the injection of local anaesthetic.)
- Pain catastrophizing tendency(Before the surgery.)
- Functional outcome(Before and 3 months after the surgery.)
- Expected pain level(Before the surgery.)
- Painkiller consumption(After the surgery until 3rd postoperative night.)
- Patient satisfaction(3 months after the surgery.)
- Analgesia duration(Every 4 hours after the surgery until 3rd postoperative night.)
- Burning pain level with VAS(VAS is recorded immediately after the injection of local anaesthetic.)
- CTR pain level(VAS is recorded right after CTR surgery)