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

NCT06949488 | Active Not Recruiting

• 1 other identifier: RHDIRB2018122002
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Limb Surgery; Brachial Plexus Blockade

Keywords

Brachial Plexus Blockade; Mangesuim sulphate; ultrasound; Dexamethasone; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• -Post operative Visual analogue scale VAS score

  Assess post-operative VAS score at: T0 (after transferring to the recovery area), at T1: at two hours, T3: at four hours, T4: at six hours, T5: at eight hours, T6: at 10 hours, T7: at 12 hours, T8: at 16 hours, T9: at 20 hours, and T10 at 24 hours postoperatively.

  Over 24 hours post operative starting from transeferring the patient to the recovery area.

Secondary Outcomes (9)

• Onst of sensory block

  Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes

• Onset of motor block

  Complete motor block will be assessed every 5 min up to a maximum of 30 minutes

• Duration of the sensory block

  Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .

• duration of the motor block

  Motor power will be assessed every 4 hours till return of normal sensation up to maximum 24 hourswill be assessed every 4 hours till return of normal sensation up to maximum 24 hours

• Intraoperative mean arterial blood pressure

  From positioning the patient to the block upto 90 minutes from removing the needle

Study Arms (3)

Group A (DT): Dexmedetomidine group

EXPERIMENTAL

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

Procedure: Group A (DT): Dexmedetomidine group

Group B (MG): Magnesium group

EXPERIMENTAL

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.

Procedure: Group B (MG): Magnesium group

Group C (DM): Dexamethasone group

ACTIVE COMPARATOR

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

Procedure: Group C (DM): Dexamethasone group

Interventions

Group A (DT): Dexmedetomidine group 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 A (DT): Dexmedetomidine group

Group B (MG): Magnesium group 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 B (MG): Magnesium group

Group C (DM): Dexamethasone group 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.

Group C (DM): Dexamethasone group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculity of medicine - Al-Azhar University hospitals

Cairo, Cairo Governorate, 11884, Egypt

Location

Related Publications (5)

• 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.

  PMID: 11873038 BACKGROUND

• 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.

  PMID: 11913804 BACKGROUND

• 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.

  PMID: 33209562 BACKGROUND

• 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.

  PMID: 34041719 BACKGROUND

• 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.

  PMID: 22207517 BACKGROUND

Study Officials

• Hend Mostafa Abosaifa, MD

  Al-Azhar University

  STUDY DIRECTOR

• Fatma Alzahraa Roshdy Elkemary, MD

  Al-Azhar Unversity

  PRINCIPAL INVESTIGATOR

• Noha Mohamed Elsai, MD

  Al-Azhar Unversity

  STUDY CHAIR

• Ain ELmarwa Abdelmonem Abdallah, MD

  Al-Azhar Unversity

  PRINCIPAL INVESTIGATOR

• Nashwa Mohammed Ibrahiem, MD

  Al-Azhar Unversity

  STUDY CHAIR

• Wafaa Abd Ali Elhadi, MD

  Al-Azhar Unversity

  STUDY CHAIR

• Hanaa Said Rashed, MD

  National liver institute Menofia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, Intensive care and pain management.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: December 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

EG (1)