Carpal Tunnel SyndromeDELICATENCT05328180
aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE)
A study testing Sodium bicarbonate in people with Carpal Tunnel Syndrome, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Sodium bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFinland
- Study dates
- 21 Sep 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically and electrophysiologically diagnosed carpal tunnel syndrome
- Patients who are scheduled for carpal tunnel release surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery
Kuopio, Northern Savonia, 70029
About this study
Official title: aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE): A Randomized Controlled Trial
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.
Read more
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
- Being tested
- Sodium bicarbonate, Control arm
- Keywords
- Carpal Tunnel Release, Bicarbonate, Local anaesthesia, Wide awake lidocain cum adrenalin no tourniquet, Pain, Carpal tunnel syndrome
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateOther
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.
Control armOther
A 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: VAS is recorded immediately after the injection of local anaesthetic.
Secondary outcomes (11)
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.
Measured: VAS is recorded immediately after the injection of local anaesthetic.
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.
Measured: VAS is recorded immediately after the injection of local anaesthetic.
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.
Measured: VAS is recorded immediately after the injection of local anaesthetic.
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.
Measured: VAS is recorded right after CTR surgery
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.
Measured: Every 4 hours after the surgery until 3rd postoperative night.
Painkiller consumption
The investigators record the painkiller consumption after the surgery.
Measured: After the surgery until 3rd postoperative night.
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.
Measured: Immediately after the injection of 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.
Measured: Before the surgery.
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.
Measured: Before and 3 months after the surgery.
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.
Measured: 3 months after the surgery.
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.
Measured: Before the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start21 Sep 2022
- Primary completion30 Jun 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two concurrent study groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Sponsor
- Investigators
- Yrjänä Nietosvaara, Prof., Study director, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328180
- Sponsor's protocol ID
- KUH5203139
- Acronym
- DELICATE
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators share pseudonymised data in EU/ETA if it is separately requested.
Publications
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.
PubMed 37723109
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05328180
- Acronym / sponsor ID
- DELICATE / KUH5203139
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Release, Bicarbonate, Local anaesthesia, Wide awake lidocain cum adrenalin no tourniquet, Pain, Carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two concurrent study groups
| Arm | Type | Receives |
|---|---|---|
| Non-buffered local anaesthetic | Other | Other: Control armThe investigators allocate 58 patients in this arm. It serves as the control group, who receives currently used local anaesthetic solution. |
| Buffered local anaesthetic | Experimental | Other: Sodium bicarbonateThe investigators allocate 58 patients in this arm. It serves as the experimental group, who receives currently used anaesthetic solution that has been buffered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically and electrophysiologically diagnosed carpal tunnel syndrome
- Patients who are scheduled for carpal tunnel release surgery.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateA 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5% is buffered with 7.5% sodium bicarbonate in 1:10. | Other | Buffered local anaesthetic |
| Control armA 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5%. | Other | Non-buffered local anaesthetic |
Primary outcome
Total pain level with visual analogic scale (VAS)
Time frame: VAS is recorded immediately after the injection of local anaesthetic.
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.
11 secondary outcomes
Burning pain level with VAS
Time frame: VAS is recorded immediately after the injection of local anaesthetic.
Pressure pain level with VAS
Time frame: VAS is recorded immediately after the injection of local anaesthetic.
Needle sting pain level with VAS
Time frame: VAS is recorded immediately after the injection of local anaesthetic.
CTR pain level
Time frame: VAS is recorded right after CTR surgery
Analgesia duration
Time frame: Every 4 hours after the surgery until 3rd postoperative night.
Painkiller consumption
Time frame: After the surgery until 3rd postoperative night.
Number of needle stings
Time frame: Immediately after the injection of local anaesthetic.
Pain catastrophizing tendency
Time frame: Before the surgery.
Functional outcome
Time frame: Before and 3 months after the surgery.
Patient satisfaction
Time frame: 3 months after the surgery.
Expected pain level
Time frame: Before the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 37723109Hytonen 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.
- Individual participant dataSharing planned: Yes. The investigators share pseudonymised data in EU/ETA if it is separately requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yrjänä Nietosvaara, Prof. study director
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate in people with Carpal Tunnel Syndrome, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pain level with visual analogic scale (VAS) (time frame: VAS is recorded immediately after the injection of local anaesthetic.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05328180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.