Articaine Plus Dexmedetomidine in Supraclavicular Block

NCT06423859 | Recruiting

• 1 other identifier: RC 19-1-2024
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• onset time of sensory block

  15 minutes after block

• onset time for motor block

  15 minutes after block

• motor duration block

  24 hours post block

• Analgesia time

  24 hours postoperative

Study Arms (2)

Articaine alone

ACTIVE COMPARATOR

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

Articaine and Dexmedetomidine

EXPERIMENTAL

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; Drug: Dexmedetomidine

Interventions

Articaine DRUG

supraclavicular brachial plexus block with articaine 2%

Articaine alone; Articaine and Dexmedetomidine

Dexmedetomidine DRUG

supraclavicular brachial plexus block with articaine 2% in addition with Dexmedetomidine

Articaine and Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Carticaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Central Study Contacts

Samar R Amin, MD

CONTACT

+201287793991; samar.rafik@gmail.com

Elsayed M abdelzaam, MD

CONTACT

0133227518; sayedzim12@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anaesthesia and intensive care

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 20, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

EG (1)