Articaine Plus Dexmedetomidine in Supraclavicular Block

NCT ID: NCT06423859

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-08-20

Brief Summary

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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

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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.

Conditions

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Post Operative Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Articaine

Intervention Type DRUG

supraclavicular brachial plexus block with articaine 2%

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)

Group Type EXPERIMENTAL

Articaine

Intervention Type DRUG

supraclavicular brachial plexus block with articaine 2%

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Articaine

supraclavicular brachial plexus block with articaine 2%

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Samar Rafik Mohamed Amin

Assistant professor of anaesthesia and intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Samar R Amin, MD

Role: CONTACT

+201287793991

Elsayed M abdelzaam, MD

Role: CONTACT

0133227518

Facility Contacts

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Samar R. Amin, lecturer

Role: primary

01287793991

Other Identifiers

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RC 19-1-2024

Identifier Type: -

Identifier Source: org_study_id

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