## Protocol Section
### Identification Module
**NCT ID:** NCT06423859

**Brief Title:** 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

#### Organization Study ID Info
**ID:** RC 19-1-2024
#### Organization
**Class:** OTHER
**Full Name:** Benha University
### Status Module
#### Completion Date
**Date:** 2024-08-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Benha University

#### Responsible Party

**Investigator Affiliation:** Benha University

**Investigator Full Name:** Samar Rafik Mohamed Amin

**Investigator Title:** Assistant professor of anaesthesia and intensive care

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Post Operative Pain, Acute

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 66

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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)

**Intervention Names:**

- Drug: Articaine

**Label:** Articaine alone

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**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)

**Intervention Names:**

- Drug: Articaine

- Drug: Dexmedetomidine

**Label:** Articaine and Dexmedetomidine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Articaine alone

- Articaine and Dexmedetomidine

**Description:** supraclavicular brachial plexus block with articaine 2%

**Name:** Articaine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Articaine and Dexmedetomidine

**Description:** supraclavicular brachial plexus block with articaine 2% in addition with Dexmedetomidine

**Name:** Dexmedetomidine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** the time between the onset of sensory block to the complete resolution of anesthesia on all nerves distribution.

**Measure:** Sensory block duration

**Time Frame:** 24 hours post block

#### Secondary Outcomes

**Description:** 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

**Measure:** onset time of sensory block

**Time Frame:** 15 minutes after block

**Description:** the time between the end of the drug injection and Grade 1 motor block

**Measure:** onset time for motor block

**Time Frame:** 15 minutes after block

**Description:** the time interval between the onset time of motor block and the recovery of complete motor function of that limb

**Measure:** motor duration block

**Time Frame:** 24 hours post block

**Description:** time interval between the administration of local anesthesia solution and onset of pain at surgical site

**Measure:** Analgesia time

**Time Frame:** 24 hours postoperative

### Eligibility Module

**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.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** samar.rafik@gmail.com

**Name:** Samar R Amin, MD

**Phone:** +201287793991

**Role:** CONTACT

**Contact 2:**

**Email:** sayedzim12@yahoo.com

**Name:** Elsayed M abdelzaam, MD

**Phone:** 0133227518

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Banhā

**Contacts:**

***Contact 1:***

- **Email:** samar.rafik@gmail.com

- **Name:** Samar R. Amin, lecturer

- **Phone:** 01287793991

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Samar Rafik Mohamed Amin

**State:** Qalubia

**Status:** RECRUITING

**Zip:** 13511

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Post Operative Pain, Acute

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Twice daily

- ID: M5609

- Name: Carticaine

- Relevance: HIGH

- As Found: Earlier

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000020927

- Term: Dexmedetomidine

- ID: D000002355

- Term: Carticaine

### Misc Info Module

- Version Holder: 2024-05-31
