PERSONNEL: Carpal Tunnel Release Under Local Infiltration Anaesthesia Versus Local Infiltration Anaesthesia and Median Nerve Block

Sponsor

Kuopio University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05372393

Collaborator

University of Eastern Finland (Other)

118

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Carpal tunnel syndrome (CTS) is the most common 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, local, axillary- or intravenous block or general anaesthesia. There are no randomised controlled trials (RCT), comparing local infiltration anaesthesia to local infiltration anaesthesia augmented with distal median nerve block in CTR.

The investigators' aim is to find out if distal median nerve block in adjunct to WALANT surgery reduces pain during CTR and postoperatively. The investigators' primary hypothesis is that distal median nerve block, in adjunct to local infiltration anaesthesia does not reduce pain during and after CTR compared to pure local anaesthesia.

The study is a blinded randomized controlled trial in patients with CTR. Patients will be randomly divided into two study groups. CTR is performed under WALANT. The first group will have local infiltration anaesthesia and distal median nerve block and the other local infiltration anaesthesia. The primary outcome measure is the pain level perceived by patient during the procedure using the visual analogue scale (VAS).

CTR is the most common hand surgical procedure, which is well suited for WALANT. The optimal method of local anaesthesia is however not clear. Possible advantages or disadvantages of median nerve blockade in adjunct to local infiltration anaesthesia can be assessed by a high-quality RCT.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Procedure: Distal median nerve block and local infiltration anaesthesia Procedure: Local infiltration anaesthesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two concurrent study groupsTwo concurrent study groups

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Carpal Tunnel Release Under Local Infiltration Anaesthesia Versus Local Infiltration Anaesthesia and Median Nerve Block- a Study Protocol of a Blinded Randomized Controlled Trial.

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Local infiltration anaesthesia The investigators allocate 59 patients in this arm. It serves as the control group, who receives local infiltration anaesthesia.	Procedure: Local infiltration anaesthesia The anaesthetic cocktail consists of 4,5 ml of lidocaine with adrenalin 1%, 4,5 ml of bupivacaine with adrenalin 0.5% and 1 ml of (7.5%) sodium bicarbonate. The investigators use a 24 gauge hypodermic needle to inject the solution.
Experimental: Local infiltration anaesthesia and distal median nerve block The investigators allocate 59 patients in this arm. It serves as the experimental group, who receives local infiltration anaesthesia and distal median nerve block.	Procedure: Distal median nerve block and local infiltration anaesthesia Local infiltration anaesthesia: The anaesthetic cocktail consists of 4,5 ml of lidocaine with adrenalin 1%, 4,5 ml of bupivacaine with adrenalin 0.5% and 1 ml of (7.5%) sodium bicarbonate. The investigators use a 24 gauge hypodermic needle to inject the solution.

Arm

Intervention/Treatment

Other: Local infiltration anaesthesia

The investigators allocate 59 patients in this arm. It serves as the control group, who receives local infiltration anaesthesia.

Procedure: Local infiltration anaesthesia

The anaesthetic cocktail consists of 4,5 ml of lidocaine with adrenalin 1%, 4,5 ml of bupivacaine with adrenalin 0.5% and 1 ml of (7.5%) sodium bicarbonate. The investigators use a 24 gauge hypodermic needle to inject the solution.

Experimental: Local infiltration anaesthesia and distal median nerve block

The investigators allocate 59 patients in this arm. It serves as the experimental group, who receives local infiltration anaesthesia and distal median nerve block.

Procedure: Distal median nerve block and local infiltration anaesthesia

Local infiltration anaesthesia: The anaesthetic cocktail consists of 4,5 ml of lidocaine with adrenalin 1%, 4,5 ml of bupivacaine with adrenalin 0.5% and 1 ml of (7.5%) sodium bicarbonate. The investigators use a 24 gauge hypodermic needle to inject the solution.

Outcome Measures

Primary Outcome Measures

Pain level during the procedure with visual analogic scale (VAS) [Visual analogic scale is recorded immediately after the procedure]
The investigators evaluate the pain level perceived by patient during the procedure using visual analogic scale. The visual analog 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

Pain sensitivity using PCS-FINv2.0 form [Preoperatively]
The investigators evaluate pain sensitivity between patients using PCS-FINv2.0 form. The investigators ask patients to fill pain catastrophizing tendency evaluating form before the surgery in order to evaluate the pain levels between the experimental and control group.
Expected pain level using visual analogic scale (VAS) [Preoperatively]
The difference between the expected pain using visual analogic scale (VAS). The investigators ask the patients to evaluate the pain they expect to experience during procedure. The visual analog 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 [Every 4 hours while awake after the surgery until 3rd postoperative night.]
The investigators assess the length of the anaesthesia by recording the pain level with visual analog scale (VAS) every 4 hours while awake. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Patients' symptom severity and overall functional status [Before and 3 months after the surgery]
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.
Consumption of pain killers [After the surgery until 3rd postoperative night]
The investigators record the consumption of pain killers after surgery
Patient satisfaction [3 months after the surgery]
Patients evaluate how likely they would recommend the procedure to the fellowman 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.
Number of experienced needle stings [Immediately after the injection of local anaesthetic.]
The investigators ask the patient to report how many needle stings they felt when the investigators performed the anaesthesia
Pain caused by needle sting-, tension- and burning [Postoperatively, immediately after the procedure]
The investigators record pain perceived during the injection of the anaesthetic solution caused by needle sting-, tension- and burning using VAS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Over 17 years of age with CTS verified by nerve conduction studies

Exclusion Criteria:

Patients under 18 years, previous or recurrent carpal tunnel syndrome, repeat surgery, peripheral neuropathies like cervical radiculopathy and cubital tunnel syndrome, known allergy to the trial drugs, profound cognitive impairment, and pregnancy