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

NCT05328180 | Active Not Recruiting

• 1 other identifier: KUH5203139
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Release; Bicarbonate; Local anaesthesia; Wide awake lidocain cum adrenalin no tourniquet; Pain; Carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  VAS is recorded immediately after the injection of local anaesthetic.

Secondary Outcomes (11)

• Burning pain level with VAS

  VAS is recorded immediately after the injection of local anaesthetic.

• Pressure pain level with VAS

  VAS is recorded immediately after the injection of local anaesthetic.

• Needle sting pain level with VAS

  VAS is recorded immediately after the injection of local anaesthetic.

• CTR pain level

  VAS is recorded right after CTR surgery

• Analgesia duration

  Every 4 hours after the surgery until 3rd postoperative night.

Study Arms (2)

Non-buffered local anaesthetic

OTHER

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

Other: Control arm

Buffered local anaesthetic

EXPERIMENTAL

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

Interventions

Sodium bicarbonate OTHER

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.

Buffered local anaesthetic

Control arm OTHER

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

Non-buffered local anaesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery

Kuopio, Northern Savonia, 70029, Finland

Location

Related Publications (1)

• Hytonen M, Nietosvaara Y, Reito A, Sirola J, Heikkinen N, Savolainen A, Raisanen MP. Protocol for a double-blinded randomised controlled trial investigating the use of adjunct bicarbonate in carpal tunnel release: a single-centre study. BMJ Open. 2023 Sep 18;13(9):e071488. doi: 10.1136/bmjopen-2022-071488.

  PMID: 37723109 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yrjänä Nietosvaara, Prof.

  Kuopio University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two concurrent study groups

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: September 21, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for 15 years after the study has ended.
• Access Criteria: Request must come from an EU/ETA country. The investigators do not share data outside these countries.

Locations

FI (1)