- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07617064
WALANT Versus Local Anesthesia With Tourniquet for Carpal Tunnel Decompression (WALANT vs LA-T)
Intraoperative Pain During Carpal Tunnel Release: Wide-Awake Local Anesthesia No Tourniquet Versus Local Anesthesia and Tourniquet - A Randomized Controlled Trial
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Cairo, Egypten
- Al-Azhar University Hospital (Neurosurgery Department)
-
Giza, Egypten
- Misr University for Science and Technology Hospital (Orthopedic Surgery Department)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Adults (≥18 years) with clinically and electrophysiologically confirmed carpal tunnel syndrome.
Candidate for surgical treatment with open carpal tunnel decompression.
American Society of Anesthesiologists (ASA) physical status I or II.
Able and willing to provide written informed consent.
Exclusion Criteria:
- Surgery-related anxiety requiring sedation or general anesthesia.
Known contraindication or allergy to lidocaine or epinephrine.
Active local or systemic infection at or near the surgical site.
ASA physical status III or higher.
Pregnancy or breastfeeding.
Any condition preventing reliable pain scoring or follow-up according to investigator judgment.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: WALANT (Wide-Awake Local Anesthesia No Tourniquet)
"Patients received wide-awake local anesthesia with epinephrine infiltration in the operative field, without arm tourniquet or routine sedation, for open carpal tunnel decompression."
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"Twenty milliliters of 1% lidocaine (200 mg) with epinephrine 1:100,000, buffered with 8.4% sodium bicarbonate at a 10:1 ratio, were infiltrated into the operative field approximately 20 minutes before incision.
No tourniquet was applied.
A mini-open CTD through a 2-3 cm incision was performed in a minor procedure room under full aseptic technique.
Hemostasis relied on epinephrine-mediated vasoconstriction and meticulous surgery."
|
|
Aktiv komparator: Local Anesthesia With Tourniquet (LA-T)
"Patients received buffered lidocaine without epinephrine and an upper-arm pneumatic tourniquet for open carpal tunnel decompression."
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"Twenty milliliters of 1% lidocaine (200 mg) buffered identically to the WALANT solution but without epinephrine were infiltrated approximately 5 minutes before incision in the operating room.
A blood pressure cuff tourniquet was placed above the elbow, inflated to 100 mmHg above systolic pressure after arm elevation and draping, and released after wound closure.
Mini-open CTD was performed through a 2-3 cm incision under standard aseptic conditions."
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intraoperative Pain (VAS)
Tidsram: Intraoperative.
|
"Overall intraoperative pain scored by the patient using a visual analog scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).
The patient rated the overall pain experienced during surgery on a standardized questionnaire administered by a blinded assessor."
|
Intraoperative.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Infiltration Pain (VAS)
Tidsram: Perioperative " During local anesthetic injection, assessed immediately after infiltration."
|
"Pain at the time of local anesthetic infiltration, scored on a VAS 0-10."
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Perioperative " During local anesthetic injection, assessed immediately after infiltration."
|
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Tourniquet Pain (VAS) - LA-T Group Only
Tidsram: Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
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"Tourniquet-specific pain in the LA-T group, scored on VAS 0-10, recorded separately from overall intraoperative pain."
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Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
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Operative Time
Tidsram: Intraoperative (from first skin incision to final skin closure).
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"Operative time in minutes, recorded from incision to completion of skin closure."
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Intraoperative (from first skin incision to final skin closure).
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Patient Satisfaction With Operating Room Experience
Tidsram: Day 1 Postoperative
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"Global patient satisfaction with the operating room experience, assessed using a numeric rating scale from 0 (not satisfied) to 10 (fully satisfied)."
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Day 1 Postoperative
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Intraoperative Complications
Tidsram: Baseline up to 30 days postoperatively.
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"Any deviation from the normal operative course, including bleeding requiring intervention, nerve injury, or other intraoperative adverse events, captured on the standardized operative record and postoperative questionnaire."
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Baseline up to 30 days postoperatively.
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Mohammed S.K. Hamza, MD, PhD, Faculty of Medicine, Misr University for Science and Technology, Giza, Egypt
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i nervsystemet
- Sår och skador
- Neuromuskulära sjukdomar
- Sjukdomar i det perifera nervsystemet
- Median neuropati
- Mononeuropatier
- Nervkompressionssyndrom
- Kumulativa traumastörningar
- Stukning och stammar
- Beteende
- Behandlingsefterlevnad och efterlevnad
- Hälsobeteende
- Karpaltunnelsyndrom
- Patientnöjdhet
- Utrustning och förnödenheter
- Anestesi och analgesi
- Anestesi, ledning
- Anestesi
- Anestesi, lokal
- Tourniquets
Andra studie-ID-nummer
- WALANTvsLAT-CTD-RCT-01
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