Trial Radar KI
Die klinische Studie NCT07249827 für Analgesie, Akuter Schmerz, Upper Extremity Surgery, Nervenblockade ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
Eine Studie entspricht den Filterkriterien
Kartenansicht

A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guided Infraclavicular Block Phase 2 69 Randomisiert

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07249827 untersucht Supportivtherapie im Zusammenhang mit Analgesie, Akuter Schmerz, Upper Extremity Surgery, Nervenblockade. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 28. Dezember 2025. Es ist geplant, 69 Teilnehmer aufzunehmen. Durchgeführt von McGill-Universität wird der Abschluss für 30. Juni 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 7. Januar 2026 aktualisiert.
Kurzbeschreibung
This study will compare three different doses of perineural dexmedetomidine 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). Our research hypothesis is that 1.33 mcg/kg will provide a 15%-longer duration than 1mcg/kg, which in turn will provide a 15%-longer duration than 0.67 mcg/kg. Since analgesic duration and sensory durat...Mehr anzeigen
Ausführliche Beschreibung
With the approval of Ethics Committee of the McGill University Health Centre, a total of 69 patients undergoing upper extremity surgery (elbow and below) will be recruited. Recruitment will be carried out by an investigator not involved in patient care one day before surgery

All ICBs will be supervised by the coauthors and conducted preoperatively in an induction room.

After skin disinfection and draping, the ICB w...

Mehr anzeigen
Offizieller Titel

A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guided Infraclavicular Block

Erkrankungen
AnalgesieAkuter SchmerzUpper Extremity SurgeryNervenblockade
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • 2025-11084
NCT-Nummer
Studienbeginn (tatsächlich)
2025-12-28
Zuletzt aktualisiert
2026-01-07
Studienende (vorauss.)
2026-06-30
Geplante Rekrutierung
69
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
Analgesia
Acute pain
Brachial plexus
Brachial plexus block
Postoperative pain
Nerve block
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Experimentell0.67 mcg/kg
Addition of dexmedetomidine 0.67 mcg/kg to local anesthetics in infraclavicular brachial plexus block
dexmedetomidine (perineural) 0.67 mcg/kg
Perineural dexmedetomidine 0.67 mcg/kg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.
Experimentell1 mcg/kg
Addition of dexmedetomidine 1 mcg/kg to local anesthetics in infraclavicular brachial plexus block
dexmedetomidine (perineural) 1 mcg/kg
Perineural dexmedetomidine 1 mcg/kg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.
Experimentell1.33 mcg/kg
Addition of dexmedetomidine 1.33 mcg/kg to local anesthetics in infraclavicular brachial plexus block
dexmedetomidine (perineural) 1.33 mcg/kg
Perineural dexmedetomidine 1.33 mcg/kg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Motor block duration
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement
24-48 hours after block
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Sensory block duration
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the return of hand and fingers sensation
24-48 hours after block
Analgesic block duration
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the first sensation of pain in the surgical area
24-48 hours after block
Block performance time
Sum of: 1- the acquisition time of the ultrasonographic image. and 2- the time to perform the block itself (from the skin anesthesia to the end of local anesthetic injection)
1 hour before surgery
Intensity of pain during block procedure
Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported.
1 hour before surgery
Block onset time
Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points. The sensorimotor score is described in outcome 7.
1 hour before surgery
Sensory and motor block score
The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, medium, radial, and ulnar nerves. Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch. The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16.
30 minutes after the ending time of local anesthetic injection
Incidence of complete block
Percentage of blocks with a minimal sensorimotor composite score of 14 points out of a maximum of 16 points at 30 minutes after the injection
30 minutes after the ending time of local anesthetic injection
Incidence of surgical anesthesia
Ability to proceed with surgery without the need for intravenous narcotics, general anesthesia, rescue blocks or local anesthesia infiltration by the surgeon
30-60 minutes after the ending time of local anesthetic injection
Incidence of nerve block side effects
Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, Horner syndrome, hoarseness, or pneumothorax after the block.
0 minutes after skin disinfection to 30 minutes after the nerve block
Respiratory depression
Presence of low respiratory rates (lower than 8 breaths per minute) or persistent oxygen requirements (pulse oximetry lower than 90% without supplementary oxygen). The respiratory rate and pulse oximetry are continuously measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached
30 minutes after the nerve block to 2 hours after surgery
Bradycardia
Defined as a heart rate lower than 50 beats per minute. The heart rate is continuously measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached
30 minutes after the nerve block to 2 hours after surgery
Hypotension
Mean arterial pressure lower than 60 mmHg. The blood pressure is measured intra- and post-operatively (in the post-anesthetic care unit) as a standard of care with a multiparameter monitor. Alarms are set to alert when predetermined levels are reached
30 minutes after the nerve block to 2 hours after surgery
Postoperative persistent sedation
Persistent sedation after surgery using Ramsay sedation scale. The scale has 6 points from 1 to 6. A higher score represents a more sedated patient. 1= anxious, agitated or restless; 2= co-operative, oriented and tranquil; 3= responds to command only; 4= brisk response to light pain or loud auditory stimulus; 5= sluggish response to light pain or loud auditory stimulus; 6= no response.
2 hours after surgery
Persistent neurologic deficit
Presence of persistent sensory or motor postoperative deficit. The patients will be contacted by telephone and inquired about any sensory or motor deficit in the operated extremity.
7 days after surgery
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • patients undergoing upper limb surgery at or below the elbow
  • age between 18 and 75 years
  • American Society of Anesthesiologists classification 1-3
  • body mass index between 18 and 35 kg/m2

  • adults who are unable to give their own consent
  • allergy or contraindication to dexmedetomidine
  • exposure to dexmedetomidine during the previous 48 hrs
  • pre-existing neuropathy (assessed by history and physical examination)
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood workup i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work-up i.e. creatinine. eGFR < 90)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work-up i.e. transaminases ≥ 100)
  • allergy to LA
  • pregnancy (as institutional policy, female patients with childbearing potential undergoing non urgent surgery are tested preoperatively for pregnancy with blood tests)
  • breast feeding
  • prior surgery in the infraclavicular region
  • chronic pain syndromes requiring opioid intake at home
McGill University Health Centre/Research Institute of the McGill University Health Centre logoMcGill-Universität
Verantwortliche Partei
Julián Aliste, Hauptprüfer, Associate Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
Zentrale Studienkontakte
Kontakt: Julián Aliste, MD, 514-934-1934, [email protected]
1 Studienstandorte in 1 Ländern

Quebec

McGill University Health Centre, Montreal, Quebec, H3G 1A4, Canada
Samita Pirotesak, M.D., Kontakt, 4384067337, [email protected]
Offene Rekrutierung