- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Cairo, Egypt
- Al-Azhar University Hospital (Neurosurgery Department)
-
Giza, Egypt
- Misr University for Science and Technology Hospital (Orthopedic Surgery Department)
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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."
|
"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."
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intraoperative Pain (VAS)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Infiltration Pain (VAS)
Tidsramme: Perioperative " During local anesthetic injection, assessed immediately after infiltration."
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"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."
|
|
Tourniquet Pain (VAS) - LA-T Group Only
Tidsramme: 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
Tidsramme: Intraoperative (from first skin incision to final skin closure).
|
"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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Mohammed S.K. Hamza, MD, PhD, Faculty of Medicine, Misr University for Science and Technology, Giza, Egypt
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
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- Torniketter
Andre studie-ID-numre
- WALANTvsLAT-CTD-RCT-01
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