DELICATE: Adjunct Bicarbonate vs. no Bicarbonate in Local Anaesthesia for Carpal Tunnel Release

Sponsor

Kuopio University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05328180

Collaborator

University of Eastern Finland (Other)

106

Enrollment

Location

Arms

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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 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 106 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 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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Other: Sodium bicarbonate Other: Control arm	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two concurrent study groupsTwo concurrent study groups

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

aDjunct bicarbonatE vs. no Bicarbonate in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE). A Randomized Controlled Trial

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Other: Control arm A 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5%.
Experimental: Buffered local anaesthetic The investigators allocate 58 patients in this arm. It serves as the experimental group, who receives currently used anaesthetic solution that has been buffered.	Other: Sodium bicarbonate 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.

Arm

Intervention/Treatment

Other: 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.

Other: Control arm

A 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5%.

Experimental: Buffered local anaesthetic

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

Other: Sodium bicarbonate

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.

Outcome Measures

Primary Outcome Measures

Pain level with visual analogic scale (VAS) [VAS is recorded immediately after the injection of local anaesthetic.]
The investigators evaluate the burning, pressure, needle sting and total pain with 0-100 mm visual analogic 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

Analgesia duration [Every 4 hours after the surgery until 3rd postoperative night.]
The investigators assess the length of the anaesthesia by recording the pain level with visual analogic 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 [After the surgery until 3rd postoperative night.]
The investigators record the painkiller consumption after the surgery.
Number of needle stings [Immediately after the injection of local anaesthetic.]
The investigators ask the patient to report how many needle stings the patient felt during the injection of the local anaesthetic.
Pain catastrophizing tendency [Before the surgery.]
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 [Before and 3 months after the surgery.]
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 [3 months after the surgery.]
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 [Before the surgery.]
The investigators ask the patients to evaluate the pain the patient expect to experience during administration of local anaesthetic using visual analogic scale (VAS). This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
Diabetes mellitus
Chronic renal failure
Rheumatoid arthritis
Allergies to lidocaine
Pregnancy
Profound cognitive impairment
A history of a previous carpal tunnel decompression