Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block
- Conditions
- Carpal Tunnel Syndrome
- Interventions
- Procedure: Local infiltration anaesthesia in carpal tunnel releaseProcedure: Distal median nerve block with local infiltration anaesthesia in carpal tunnel release
- Registration Number
- NCT05372393
- Lead Sponsor
- Kuopio University Hospital
- Brief Summary
Carpal tunnel syndrome is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and surgical methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. Surgery can be done under an axillary- or intravenous block, or local or general anaesthesia. There are no randomised controlled trials comparing local infiltration anaesthesia with or without a distal median nerve block in carpal tunnel release.
The aim of the study is to investigate whether a distal median nerve block, in addition to local anaesthesia in carpal tunnel release, reduces pain during and after the procedure. 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.
This trial is a randomised controlled trial involving patients with carpal tunnel syndrome. Patients will be randomized into two study groups: local anaesthesia and local with a distal median nerve block. Fifty-nine patients will be needed for each group to have adequate power. The primary outcome is the pain level after the procedure for 72 hours using visual analogue scale. The secondary outcomes include expected pain; pain during the injection of the anaesthetic solution caused by pressure, burning, needle sting, and total pain; worst pain during the surgery; duration of anaesthesia; number of experienced needle stings; Boston Carpal Tunnel Syndrome Questionnaire; pain killer consumption, patient satisfaction, and safety .
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. Distal median block in CTR is believed to reduce pain intra- and postoperatively. However, the superiority of distal median block with local anaesthesia compared to pure local anaesthesia alone has not been proven.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 118
- Over 17 years of age
- CTS verified by nerve conduction studies
- Symptoms suitable for CTS
- Recurrent CTS
- Peripheral neuropathies
- Known allergy to the trial drugs
- Profound cognitive impairment
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Local infiltration anaesthesia in carpal tunnel release Local infiltration anaesthesia in carpal tunnel release The investigators allocate 59 patients in this arm. It serves as the control group, who receives local infiltration anaesthesia. Distal median nerve block with local infiltration anaesthesia in carpal tunnel release Distal median nerve block with local infiltration anaesthesia in carpal tunnel release The investigators allocate 59 patients in this arm. It serves as the experimental group, who receives local infiltration anaesthesia and distal median nerve block.
- Primary Outcome Measures
Name Time Method The pain level perceived by the patient after the procedure using Visual Analogue Scale (VAS) 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 Visual analogue Scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
- Secondary Outcome Measures
Name Time Method Total pain during the injection of the anaesthetic solution (VAS) Immediately after the infiltration of anaesthetic solution The investigators ask the patients to evaluate the total pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). 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.
Burning pain (VAS) Immediately after the infiltration of anaesthetic solution The investigators ask the patients to evaluate the burning pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). 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.
Pressure pain (VAS) Immediately after the infiltration of anaesthetic solution The investigators ask the patients to evaluate the pressure pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). 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.
Needle sting pain (VAS) Immediately after the infiltration of anaesthetic solution The investigators ask the patients to evaluate the needle sting pain that the infiltration of the anaesthetic solution caused using Visual Analogue Scale (VAS). 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.
Duration of anaesthesia Postoperatively during the first 72 hours after the operation The investigators assess the length of the anaesthesia by asking the patients to fill an online form when they first time feel pain in the operation field or have to use pain killers.
Self-reported symptom severity and functional status Before and 3 months postoperatively The investigators ask the patients to evaluate their symptoms using Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score. It consists of the Symptom Severity Scale (SSS) containing 11 questions, and it uses a five-point Likert rating scale from 1 (no symptoms) to 5 (most severe symptoms), and Functional Status Scale (FSS), which has 8 questions assessing the degree of complaints on a five-point Likert scale from 1 (no symptoms) to 5 (most severe symptoms). Mean sum scores of both scales are calculated and used for analysis.
Worst pain during the operation (VAS) Immediately after the operation The investigators ask the patients to evaluate the worst pain during the operation using Visual Analogue Scale (VAS). 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.
Expected pain (VAS) Before the infiltration of the anaesthetic solution The investigators ask the patient to evaluate the pain during the infiltration of the anaestetic solution using Visual Analogue Scale (VAS). 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.
Patient satisfaction 3 months postoperatively Patients evaluate how likely they would recommend the procedure to a fellow man using Net Promoter Score (NPS). Net Promoter Score is a measurement taken from asking patients how likely they are to recommend the procedure to others on a scale of 0-10. The higher score the better outcome.
Adverse events (AE) 3 months postoperatively Health care professional assessment
Amount of perceived needle stings Immediately after the infiltration of anaesthetic solution The investigators ask the patient to report how many needle stings they felt when the anaesthesia was performed.
Consumption of pain killers Postoperatively during the first 72 hours after the operation The investigators record the consumption of pain killers after surgery
Trial Locations
- Locations (1)
Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery
🇫🇮Kuopio, Pohjois-Savo, Finland