Efficacy of Different Medications as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries

NCT ID: NCT06949488

Last Updated: 2025-04-29

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-07-30

Brief Summary

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This study is to evaluate whether addition of dexmedetomidine, dexamethasone and magnesium sulfate as adjuvants to bupivacaine in supraclavicular Brachial Plexus Blockade (BPB) for pain management assessed by VAS score.

Detailed Description

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This is a randomized controlled study involving 105 participants divided into three groups to assess the efficacy of adding dexmedetomidine, dexamethasone, and magnesium sulfate as adjuvants to bupivacaine in supraclavicular brachial plexus blockade during upper limb surgeries. The primary outcome is the postoperative Visual Analog Scale (VAS) score. The secondary outcomes are assessment of onset and duration of the block, patient satisfaction, and adverse effects.

Conditions

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Upper Limb Surgery Brachial Plexus Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A (DT): Dexmedetomidine group

A group of 35 participants will receive 18 ml of bupivacaine 0.5% plus dexmedetomidine 100 µg for the supraclavicular block.

Group Type EXPERIMENTAL

Group A (DT): Dexmedetomidine group

Intervention Type PROCEDURE

The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 100 µg Dexmeditomidine and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

Group B (MG): Magnesium group

A group of 35 participants will receive 18 ml of bupivacaine 0.5% plus magnesium sulfate 150 mg in 2 ml of normal saline for the same block.

Group Type EXPERIMENTAL

Group B (MG): Magnesium group

Intervention Type PROCEDURE

The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 150 mg of magnesium sulfate and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

Group C (DM): Dexamethasone group

A group of 35 participants will receive 18 ml of bupivacaine 0.5% plus dexamethasone 8 mg for the same block.

Group Type ACTIVE_COMPARATOR

Group C (DM): Dexamethasone group

Intervention Type PROCEDURE

The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 8 mg dexamethasone and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

Interventions

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Group A (DT): Dexmedetomidine group

The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 100 µg Dexmeditomidine and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

Intervention Type PROCEDURE

Group B (MG): Magnesium group

The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 150 mg of magnesium sulfate and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

Intervention Type PROCEDURE

Group C (DM): Dexamethasone group

The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized. The first rib appears as a hyperechoic line with the lung pleura deeper to this bony border. Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed near the main neural cluster of the brachial plexus. After negative aspiration, local anesthetic, including 8 mg dexamethasone and normal saline, with a total volume of 20 mL, is injected. Subsequently, smaller aliquots of local anesthetic are deposited near the surrounding satellite neural clusters.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) status of I and II
* undergoing forearm surgeries

Exclusion Criteria

* coagulopathies
* Local skin lesions
* Pregnancy
* Has a history of significant neurological, psychiatric, or neuromuscular disorders
* Patients refusing participation
* BMI \> 40
* Patient with COPD. hypersensitivity or allergies to local anesthesia
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Gaber Saad

Lecturer of anesthesia, Intensive care and pain management.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hend Mostafa Abosaifa, MD

Role: STUDY_DIRECTOR

Al-Azhar University

Fatma Alzahraa Roshdy Elkemary, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar Unversity

Noha Mohamed Elsai, MD

Role: STUDY_CHAIR

Al-Azhar Unversity

Ain ELmarwa Abdelmonem Abdallah, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar Unversity

Nashwa Mohammed Ibrahiem, MD

Role: STUDY_CHAIR

Al-Azhar Unversity

Wafaa Abd Ali Elhadi, MD

Role: STUDY_CHAIR

Al-Azhar Unversity

Hanaa Said Rashed, MD

Role: PRINCIPAL_INVESTIGATOR

National liver institute Menofia University

Locations

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Faculity of medicine - Al-Azhar University hospitals

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

References

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Begon S, Pickering G, Eschalier A, Dubray C. Magnesium increases morphine analgesic effect in different experimental models of pain. Anesthesiology. 2002 Mar;96(3):627-32. doi: 10.1097/00000542-200203000-00019.

Reference Type BACKGROUND
PMID: 11873038 (View on PubMed)

Kara H, Sahin N, Ulusan V, Aydogdu T. Magnesium infusion reduces perioperative pain. Eur J Anaesthesiol. 2002 Jan;19(1):52-6. doi: 10.1017/s026502150200008x.

Reference Type BACKGROUND
PMID: 11913804 (View on PubMed)

Herman J, Urits I, Eskander J, Kaye AD, Viswanath O. Correction: Adductor Canal Block Duration of Analgesia Successfully Prolonged With Perineural Dexmedetomidine and Dexamethasone in Addition to IPACK Block for Total Knee Arthroplasty. Cureus. 2020 Nov 16;12(11):c39. doi: 10.7759/cureus.c39.

Reference Type BACKGROUND
PMID: 33209562 (View on PubMed)

Zoratto D, Phelan R, Hopman WM, Wood GCA, Shyam V, DuMerton D, Shelley J, McQuaide S, Kanee L, Ho AM, McMullen M, Armstrong M, Mizubuti GB. Adductor canal block with or without added magnesium sulfate following total knee arthroplasty: a multi-arm randomized controlled trial. Can J Anaesth. 2021 Jul;68(7):1028-1037. doi: 10.1007/s12630-021-01985-5. Epub 2021 May 26.

Reference Type BACKGROUND
PMID: 34041719 (View on PubMed)

Bruce BG, Green A, Blaine TA, Wesner LV. Brachial plexus blocks for upper extremity orthopaedic surgery. J Am Acad Orthop Surg. 2012 Jan;20(1):38-47. doi: 10.5435/JAAOS-20-01-038.

Reference Type BACKGROUND
PMID: 22207517 (View on PubMed)

Other Identifiers

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RHDIRB2018122002

Identifier Type: -

Identifier Source: org_study_id

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