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aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE) (DELICATE)

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Sodium bicarbonate
Control arm
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Release, Bicarbonate, Local anaesthesia, Wide awake lidocain cum adrenalin no tourniquet, Pain, Carpal tunnel syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically and electrophysiologically diagnosed carpal tunnel syndrome
  • Patients who are scheduled for carpal tunnel release surgery.

Exclusion Criteria:

  • Associated disease or conditions, including cervical radiculopathy, cubital tunnel syndrome and other peripheral neuropathy
  • Chronic renal failure
  • Rheumatoid arthritis
  • Allergies to lidocaine
  • Pregnancy
  • Profound cognitive impairment
  • Previous carpal tunnel decompression on now operated hand

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

Non-buffered local anaesthetic

Buffered local anaesthetic

Arm Description

The investigators allocate 58 patients in this arm. It serves as the control group, who receives currently used local anaesthetic solution.

The investigators allocate 58 patients in this arm. It serves as the experimental group, who receives currently used anaesthetic solution that has been buffered.

Outcomes

Primary Outcome Measures

Total pain level with visual analogic scale (VAS)
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.

Secondary Outcome Measures

Burning pain level with VAS
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.
Pressure pain level with VAS
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.
Needle sting pain level with VAS
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.
CTR pain level
The investigators evaluate the maximum pain level patient experiences during CTR surgery with visual analogue scale (VAS). This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.
Analgesia duration
The investigators assess the length of the anaesthesia by recording the pain level with visual analogue scale (VAS) every 4 hours. This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.
Painkiller consumption
The investigators record the painkiller consumption after the surgery.
Number of needle stings
The investigators ask the patient to report how many needle stings the patient felt during the injection of the local anaesthetic.
Pain catastrophizing tendency
The investigators ask the patients to fill pain catastrophizing tendency evaluating form (PCS-FINv2.0) before the surgery in order to evaluate the pain levels between the experimental and control group. It has 13 questions and scores between 0-52. Higher score means higher pain catastrophizing tendency.
Functional outcome
The investigators ask the patients to evaluate symptoms and functional outcome using the Boston Carpal Tunnel Questionnaire (BTCQ). It has 11 questions for symptoms of carpal tunnel syndrome and scores between 11 and 55. Higher score means more symptoms. BTCQ also has 8 questions for functionality of hand and it has scores between 8 and 40. Higher scores mean worse function of the hand.
Patient satisfaction
The investigators ask the patients to evaluate the surgery experience with net promoter score (NPS). NPS has 10 steps and higher value indicates greater satisfaction.
Expected pain level
The investigators ask the patients to evaluate the pain the patient expect to experience during administration of local anaesthetic using visual analogue scale (VAS). This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.

Full Information

First Posted
April 7, 2022
Last Updated
May 25, 2023
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT05328180
Brief Title
aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE)
Acronym
DELICATE
Official Title
aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE). A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (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
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.

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, Bicarbonate, Local anaesthesia, Wide awake lidocain cum adrenalin no tourniquet, Pain, Carpal tunnel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two concurrent study groups
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-buffered local anaesthetic
Arm Type
Other
Arm Description
The investigators allocate 58 patients in this arm. It serves as the control group, who receives currently used local anaesthetic solution.
Arm Title
Buffered local anaesthetic
Arm Type
Experimental
Arm Description
The investigators allocate 58 patients in this arm. It serves as the experimental group, who receives currently used anaesthetic solution that has been buffered.
Intervention Type
Other
Intervention Name(s)
Sodium bicarbonate
Intervention Description
A 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5% is buffered with 7.5% sodium bicarbonate in 1:10.
Intervention Type
Other
Intervention Name(s)
Control arm
Intervention Description
A 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5%.
Primary Outcome Measure Information:
Title
Total pain level with visual analogic scale (VAS)
Description
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.
Time Frame
VAS is recorded immediately after the injection of local anaesthetic.
Secondary Outcome Measure Information:
Title
Burning pain level with VAS
Description
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.
Time Frame
VAS is recorded immediately after the injection of local anaesthetic.
Title
Pressure pain level with VAS
Description
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.
Time Frame
VAS is recorded immediately after the injection of local anaesthetic.
Title
Needle sting pain level with VAS
Description
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.
Time Frame
VAS is recorded immediately after the injection of local anaesthetic.
Title
CTR pain level
Description
The investigators evaluate the maximum pain level patient experiences during CTR surgery with visual analogue scale (VAS). This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.
Time Frame
VAS is recorded right after CTR surgery
Title
Analgesia duration
Description
The investigators assess the length of the anaesthesia by recording the pain level with visual analogue scale (VAS) every 4 hours. This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.
Time Frame
Every 4 hours after the surgery until 3rd postoperative night.
Title
Painkiller consumption
Description
The investigators record the painkiller consumption after the surgery.
Time Frame
After the surgery until 3rd postoperative night.
Title
Number of needle stings
Description
The investigators ask the patient to report how many needle stings the patient felt during the injection of the local anaesthetic.
Time Frame
Immediately after the injection of local anaesthetic.
Title
Pain catastrophizing tendency
Description
The investigators ask the patients to fill pain catastrophizing tendency evaluating form (PCS-FINv2.0) before the surgery in order to evaluate the pain levels between the experimental and control group. It has 13 questions and scores between 0-52. Higher score means higher pain catastrophizing tendency.
Time Frame
Before the surgery.
Title
Functional outcome
Description
The investigators ask the patients to evaluate symptoms and functional outcome using the Boston Carpal Tunnel Questionnaire (BTCQ). It has 11 questions for symptoms of carpal tunnel syndrome and scores between 11 and 55. Higher score means more symptoms. BTCQ also has 8 questions for functionality of hand and it has scores between 8 and 40. Higher scores mean worse function of the hand.
Time Frame
Before and 3 months after the surgery.
Title
Patient satisfaction
Description
The investigators ask the patients to evaluate the surgery experience with net promoter score (NPS). NPS has 10 steps and higher value indicates greater satisfaction.
Time Frame
3 months after the surgery.
Title
Expected pain level
Description
The investigators ask the patients to evaluate the pain the patient expect to experience during administration of local anaesthetic using visual analogue scale (VAS). This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.
Time Frame
Before the surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically and electrophysiologically diagnosed carpal tunnel syndrome Patients who are scheduled for carpal tunnel release surgery. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikael Hytönen, MBBS
Phone
+358405819488
Email
mikaelhy@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
70029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yrjänä Nietosvaara, Prof.
Phone
+358 44 717 6883
Email
yrjana.nietosvaara@kuh.fi
First Name & Middle Initial & Last Name & Degree
Mikael Hytönen, BM
First Name & Middle Initial & Last Name & Degree
Yrjänä Nietosvaara, Prof
First Name & Middle Initial & Last Name & Degree
Aleksi Reito, Specilist
First Name & Middle Initial & Last Name & Degree
Joonas Sirola, Ass. prof.
First Name & Middle Initial & Last Name & Degree
Mikko P Räisänen, Specialist
First Name & Middle Initial & Last Name & Degree
Noora Heikkinen, BM
First Name & Middle Initial & Last Name & Degree
Aukusti Savolainen, BM

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.

Learn more about this trial

aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE)

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