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Articaine Plus Dexmedetomidine in Supraclavicular Block

B

Benha University

Status

Enrolling

Conditions

Post Operative Pain, Acute

Treatments

Drug: Dexmedetomidine
Drug: Articaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06423859
RC 19-1-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

66 participants in 2 patient groups

Articaine alone
Active Comparator group
Description:
supraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc isotonic saline)
Treatment:
Drug: Articaine
Articaine and Dexmedetomidine
Experimental group
Description:
supraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc volume of Dexmedetomidine 1 ug/kg)
Treatment:
Drug: Articaine
Drug: Dexmedetomidine

Trial contacts and locations

1

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Central trial contact

Samar R Amin, MD; Elsayed M abdelzaam, MD

Data sourced from clinicaltrials.gov

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