Carpal Tunnel Release Under Local Infiltration Anaesthesia Versus Local Infiltration Anaesthesia and Median Nerve Block (PERSONNEL)
Primary Purpose
Carpal Tunnel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Distal median nerve block and local infiltration anaesthesia
Local infiltration anaesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel release, carpal tunnel syndrome, local infiltration anaesthesia, local anaesthesia, surgery, median nerve block, wide-awake local anaesthesia with no tourniquet, nerve block anaesthesia
Eligibility Criteria
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
Sites / Locations
- Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Local infiltration anaesthesia
Local infiltration anaesthesia and distal median nerve block
Arm Description
The investigators allocate 59 patients in this arm. It serves as the control group, who receives local infiltration anaesthesia.
The investigators allocate 59 patients in this arm. It serves as the experimental group, who receives local infiltration anaesthesia and distal median nerve block.
Outcomes
Primary Outcome Measures
The pain level perceived after the procedure using visual analogue scale (VAS)
The investigators measure the pain level perceived after the procedure every fourth hour while awake until third night postoperatively using VAS. 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
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 during the injection of the anesthetic solution using visual analogic scale (VAS)
The difference between the expected pain during the injection of the anesthetic solution 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
The investigators assess the length of the anaesthesia by asking the patients to fill online form when they first time feel pain in the operation field or have to use pain killers.
Patients' symptom severity and overall functional status
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
The investigators record the consumption of pain killers after surgery
Patient satisfaction
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
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
The investigators record pain perceived during the injection of the anaesthetic solution caused by needle sting-, tension- and burning using VAS
The most intense pain during the procedure with visual analogic scale (VAS)
The investigators evaluate the highest level of pain 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.
Full Information
NCT ID
NCT05372393
First Posted
May 9, 2022
Last Updated
January 18, 2023
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT05372393
Brief Title
Carpal Tunnel Release Under Local Infiltration Anaesthesia Versus Local Infiltration Anaesthesia and Median Nerve Block
Acronym
PERSONNEL
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel release, carpal tunnel syndrome, local infiltration anaesthesia, local anaesthesia, surgery, median nerve block, wide-awake local anaesthesia with no tourniquet, nerve block anaesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two concurrent study groups
Masking
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.
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local infiltration anaesthesia
Arm Type
Other
Arm Description
The investigators allocate 59 patients in this arm. It serves as the control group, who receives local infiltration anaesthesia.
Arm Title
Local infiltration anaesthesia and distal median nerve block
Arm Type
Experimental
Arm Description
The investigators allocate 59 patients in this arm. It serves as the experimental group, who receives local infiltration anaesthesia and distal median nerve block.
Intervention Type
Procedure
Intervention Name(s)
Distal median nerve block and local infiltration anaesthesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Local infiltration anaesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
The pain level perceived after the procedure using visual analogue scale (VAS)
Description
The investigators measure the pain level perceived after the procedure every fourth hour while awake until third night postoperatively using VAS. 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.
Time Frame
Postoperatively 72 hours after the operation
Secondary Outcome Measure Information:
Title
Pain sensitivity using PCS-FINv2.0 form
Description
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.
Time Frame
Preoperatively
Title
Expected pain level during the injection of the anesthetic solution using visual analogic scale (VAS)
Description
The difference between the expected pain during the injection of the anesthetic solution 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.
Time Frame
Preoperatively
Title
Duration of anaesthesia
Description
The investigators assess the length of the anaesthesia by asking the patients to fill online form when they first time feel pain in the operation field or have to use pain killers.
Time Frame
Postoperatively
Title
Patients' symptom severity and overall functional status
Description
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.
Time Frame
Before and 3 months after the surgery
Title
Consumption of pain killers
Description
The investigators record the consumption of pain killers after surgery
Time Frame
After the surgery until 3rd postoperative night
Title
Patient satisfaction
Description
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.
Time Frame
3 months after the surgery
Title
Number of experienced needle stings
Description
The investigators ask the patient to report how many needle stings they felt when the investigators performed the anaesthesia
Time Frame
Immediately after the injection of local anaesthetic.
Title
Pain caused by needle sting-, tension- and burning
Description
The investigators record pain perceived during the injection of the anaesthetic solution caused by needle sting-, tension- and burning using VAS
Time Frame
Postoperatively, immediately after the procedure
Title
The most intense pain during the procedure with visual analogic scale (VAS)
Description
The investigators evaluate the highest level of pain 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.
Time Frame
Visual analogic scale is recorded immediately after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noora Heikkinen, MBBS
Phone
+358504421930
Email
noorheik@student.uef.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Yrjänä Nietosvaara, Prof.
Phone
+358447176883
Email
yrjana.nietosvaara@kuh.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yrjänä Nietosvaara, Prof.
Organizational Affiliation
Kuopio University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery
City
Kuopio
State/Province
Pohjois-Savo
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yrjänä Nietosvaara, Prof.
Phone
+358447176883
Email
yrjana.nietosvaara@kuh.fi
First Name & Middle Initial & Last Name & Degree
Noora Heikkinen
First Name & Middle Initial & Last Name & Degree
Mikko Räisänen
First Name & Middle Initial & Last Name & Degree
Mikael Hytönen
First Name & Middle Initial & Last Name & Degree
Aukusti Savolainen
First Name & Middle Initial & Last Name & Degree
Joonas Sirola
First Name & Middle Initial & Last Name & Degree
Aleksi Reito
First Name & Middle Initial & Last Name & Degree
Yrjänä Nietosvaara
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators share pseudonymised data in EU/ETA if it is separately requested.
IPD Sharing Time Frame
Data will be available for 15 years after the study has ended.
IPD Sharing Access Criteria
Request must come from an EU/ETA country. The investigators do not share data outside these countries.
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Carpal Tunnel Release Under Local Infiltration Anaesthesia Versus Local Infiltration Anaesthesia and Median Nerve Block
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