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NCT Number: NCT05328180

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kuopio, Northern Savonia, 70029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control Arm

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Burning pain level with 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.

  2. Pressure pain level with 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.

  3. Needle sting pain level with 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.

  4. CTR pain level

    Time frame: VAS is recorded right after CTR surgery

    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.

  5. Analgesia duration

    Time frame: 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 analogue scale (VAS) every 4 hours. This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.

  6. Painkiller consumption

    Time frame: After the surgery until 3rd postoperative night.

    The investigators record the painkiller consumption after the surgery.

  7. Number of needle stings

    Time frame: 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.

  8. Pain catastrophizing tendency

    Time frame: 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.

  9. Functional outcome

    Time frame: 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.

  10. Patient satisfaction

    Time frame: 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.

  11. Expected pain level

    Time frame: Before the surgery.

    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.

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • University of Eastern Finland

Registry information

Official study title

aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE): A Randomized Controlled Trial

Acronym: DELICATE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2022
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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