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

Study acronym: DELICATE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jun 2025 to Jun 30, 2025
    • Study completion date: Nov 2025 to Dec 2025
    • Site details revised
    v11
  2. Notable Primary completion date: Feb 2024 to Jun 2025
    • Study completion date: May 2024 to Nov 2025
    v10
  3. Minor Re-verified, no change to tracked fieldsv9
  4. Notable Primary endpoint revised
    • Secondary endpoints: 8 to 11
    • Eligibility criteria expanded, about 2 words
    v8
  5. Minor Secondary endpoints: 7 to 8v7
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  1. Notable Primary completion date: Dec 2022 to Feb 2024
    • Enrollment target: 106 to 116
    • Study title shortened, about 2 words
    v6
  2. Minor Eligibility criteria shortened, about 2 wordsv5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2022 to Sep 21, 2022
    • Site details revised
    v4
  4. Minor Study sites: 0 to 1
    • Study completion date: May 2023 to May 2024
    v3
  5. Notable Start date: Apr 22, 2022 to Sep 1, 2022
    • Secondary endpoints: details revised at 7 of 7 entries
    • Study title revised
    • Eligibility criteria expanded, about 1 word
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05328180
Lead Sponsor Kuopio University Hospital
Collaborators: University of Eastern Finland
Conditions
(from sponsor)
Carpal Tunnel Syndrome
Related terms Carpal Tunnel Syndrome, Pain
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov