Clinical trial NCT06423859: Articaine Plus Dexmedetomidine in Supraclavicular Block
Official title: A Comparative Study Between Articaine Alone Versus Articaine Plus Dexmedetomidine for Ambulatory Orthopedic Surgery Under Supraclavicular Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain, Acute
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Articaine has emerged as a local anesthetic (LA) that produces sensory and motor blockade shorter than bupivacaine and lower in neurotoxicity than lidocaine.

Studies have shown that adding dexmedetomidine to LA produces prolongation of sensory and motor bock duration.

Early regain of motor power with adequate analgesia is needed in ambulatory surgery, for early start of physiotherapy. This study was designed to test efficacy of adding dexmedetomidine to articaine on the duration of sensory and motor block.

Detailed description: Articaine is an amide LA produced in the 1960s and first used in clinical trials in 1974. Although it is an amide that is similar to prilocaine in chemical structure, it contains a thiophene ring rather than a benzene ring. Articaine is a rapid and short acting LA, which has low neurotoxicity and appears to diffuse through tissues more readily than other commonly used LA agents. It is metabolized by nonspecific plasma esterases both in blood and tissues, leading to its rapid clearance.

α2-adrenergic receptor agonists have been the focus of interest for their sedative, analgesic, perioperative sympatholytic, and cardiovascular stabilizing effects along with providing reduction in anesthetic requirements. Dexmedetomidine may act on supraspinal (locus coeruleus) or spinal level or peripheral α2-adrenoreceptor to reduce nociceptive transmission, leading to analgesia.

Previous trials focused on adding dexmedetomidine to either levobupivacaine and bupivacaine, found augmentation of both sensory and motor block along with prolonged duration of effective analgesia. However, there remains limited knowledge of the analgesic efficacy and clinical utility of adding dexmedetomidine to articaine during peripheral nerve block in humans.

Eligibility criteria: Inclusion Criteria:

* aged 18-60 years planned for upper limb surgery below the midhumerus with an expected time of less than 90 min usually under tourniquet.

Exclusion Criteria:

* allergies to local anesthetic,
* those with ASA III and IV,
* patients who refuse to participate,
* uncooperative patients,
* patients who have infection at the site of injection,
* patients who have bleeding disorder, and patients on anticoagulant drugs.

Primary outcomes:
measure: Sensory block duration
timeFrame: 24 hours post block
Secondary outcomes:
measure: onset time of sensory block
timeFrame: 15 minutes after block
measure: onset time for motor block
timeFrame: 15 minutes after block
measure: motor duration block
timeFrame: 24 hours post block
measure: Analgesia time
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Samar Rafik Mohamed Amin
state: Qalubia
Study officials:
References: