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Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block

Study acronym: PERSONNEL
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 19, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Sep 2027 to Apr 2026
    • Publications: 23 to 25
    • Eligibility criteria shortened, about 1 word
    v8
  2. Notable Primary endpoint revisedv7 Show 7 more changesShow less
    • Primary completion date: Sep 2024 to Dec 2024
    • Interventions: Distal median nerve block and local infiltration anaesthesia (Procedure), Local infiltration anaesthesia (Procedure) to Distal median nerve block with local infiltration anaesthesia in carpal tunnel release (Procedure), Local infiltration anaesthesia in…
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: 9 to 12
    • Site contact updated
    • Publications: 21 to 23
    • Study title shortened, about 2 words
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Notable Primary endpoint revised
    • Secondary endpoints: 8 to 9
    v5
  5. 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
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Study sites: 0 to 1
    • Secondary endpoints: details revised at 3 of 8 entries
    v3
  2. Minor Secondary endpoints revised (8)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Carpal tunnel syndrome (CTS) is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and operative methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. Surgery can be performed under axillary or intravenous block, or general anaesthesia. There are no prior randomised controlled trials (RCT) comparing local infiltration anaesthesia to local infiltration anaesthesia augmented with a distal median nerve block in CTR. The aim of this trial is to investigate whether adding a distal median nerve block to local anaesthesia reduces the patient's perceived pain level for up to 72 hours after CTR, compared to using only local anaesthesia, i.e., an anaesthesia mixture injected solely in and around the planned incision and nerve release. The null hypothesis is that the use of distal median nerve block with local anaesthesia does not reduce pain after CTR compared to pure local anaesthesia. PERSONNEL (carPal tunnEl ReleaSe lOcal iNfiltratioN mEdian bLockade) is a double-blinded, i.e., patient and investigators, RCT in patients with CTS. Patients will be randomly divided into two parallel trial groups, 1:1 in size to each other. Fifty-nine patients will be needed for each group to have adequate power. The primary outcome is the pain level perceived by the patient after the procedure during the first 72 hours using the Visual Analogue Scale (VAS). Secondary outcomes include patient-rated outcome measures, safety, the entire consumption of pain killers after the surgery during the first 72 hours postoperatively, pain of performing the anaesthesia, and pain during and after the operation. No trial comparing local anaesthesia to local anaesthesia augmented with distal median nerve block has been published before. There is also no trial noting individual tolerance to pain. The quality of the median nerve block at the wrist has been achieved by using sensory or sensory-motor nerve stimulation and has been proven effective. This increases trust in the effectiveness of the treatment method, but it still needs to be adequately proven which is the goal of this trial.
Trial Details
NCT Number NCT05372393
Lead Sponsor Kuopio University Hospital
Collaborators: University of Eastern Finland
Conditions
(from sponsor)
Carpal Tunnel Syndrome
Related terms Carpal Tunnel Syndrome
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov