Articaine Plus Dexmedetomidine in Supraclavicular Block

A Comparative Study Between Articaine Alone Versus Articaine Plus Dexmedetomidine for Ambulatory Orthopedic Surgery Under Supraclavicular Block

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain, Acute
• Intervention / Treatment: Drug: Articaine; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elsayed M abdelzaam, MD; Phone Number: 0133227518; Email: sayedzim12@yahoo.com
• Study Contact Backup: Name: Samar R Amin, MD; Phone Number: +201287793991; Email: samar.rafik@gmail.com

Study Locations

• Egypt
  • Qalubia
    • Banhā, Qalubia, Egypt, 13511
      • Recruiting
      • Samar Rafik Mohamed Amin
      • Contact: Samar R. Amin, lecturer; Phone Number: 01287793991; Email: samar.rafik@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Articaine alone; 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)	Drug: Articaine; supraclavicular brachial plexus block with articaine 2%
Experimental: Articaine and Dexmedetomidine; 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)	Drug: Articaine; supraclavicular brachial plexus block with articaine 2%; Drug: Dexmedetomidine; supraclavicular brachial plexus block with articaine 2% in addition with Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory block duration	the time between the onset of sensory block to the complete resolution of anesthesia on all nerves distribution.	24 hours post block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
onset time of sensory block	The time between the end of the drug injection and the total abolition of pinprick sensation along the distribution of any of nerves - median, ulnar, radial, or musculocutaneous	15 minutes after block
onset time for motor block	the time between the end of the drug injection and Grade 1 motor block	15 minutes after block
motor duration block	the time interval between the onset time of motor block and the recovery of complete motor function of that limb	24 hours post block
Analgesia time	time interval between the administration of local anesthesia solution and onset of pain at surgical site	24 hours postoperative

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Carticaine
• Other Study ID Numbers: RC 19-1-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No