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

Efficacy of Dexmedetomidine, Dexamethasone, and Magnesium Sulphate as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries - A Randomized Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Upper Limb Surgery; Brachial Plexus Blockade
• Intervention / Treatment: Procedure: Group A (DT): Dexmedetomidine group; Procedure: Group B (MG): Magnesium group; Procedure: Group C (DM): Dexamethasone group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11884
    • Faculity of medicine - Al-Azhar University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
-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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onst of sensory block	Time in minutes from completing the block to complete sensory loss to sensation of a cold cotton pad relative to the contralateral limb.	Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes
Onset of motor block	Time in minutes from completing the block up to the time when the patient is unable to overcome gravity relative to the contralateral arm.	Complete motor block will be assessed every 5 min up to a maximum of 30 minutes
Duration of the sensory block	Complete return of the sensation in the blocked limb relative to the contralateral arm.	Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .
duration of the motor block	Complete return of the motor power in the blocked limb	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	Mean arterial blood pressure in mmHg will be assessed at T0: baseline before patient positing for the block, at T1: just after removing the needle, at T2: at 30 minutes, T3: at 60 Minutes , and T4: at 90 minutes intraoperatively	From positioning the patient to the block upto 90 minutes from removing the needle
Intraoperative Pulse rate.	pulse rate per minute will be assessed at T0: baseline before patient positing for the block, at T1: just after removing the needle, at T2: at 30 minutes, T3: at 60 Minutes, and T4: at 90 minutes intraoperatively	From positioning the patient to the block upto 90 minutes from removing the needle
Post operative opioid consumption	Postoperative total doses of pethidine in milligrams will be counted. For patients with a VAS score of more than 4, pethidine 50mg will be given intramuscularly.	Over 24 hours post operatively started form transferring the patient to the recovery area
Post operative Nausea and vomiting	Nausea and vomiting attacks will be recorded over 24 hours postoperatively.	Over 24 hours post operative starting from transferring to the recovery area.
Postoperative transient neurologic symptoms	Dysesthesia will be assessed every 12 hours postoperatively and reported	Over 48 hours post operative starting from transeferring to the recovery area.

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Hend Mostafa Abosaifa, MD, Al-Azhar University; Principal Investigator: Fatma Alzahraa Roshdy Elkemary, MD, Al-Azhar Unversity; Study Chair: Noha Mohamed Elsai, MD, Al-Azhar Unversity; Principal Investigator: Ain ELmarwa Abdelmonem Abdallah, MD, Al-Azhar Unversity; Study Chair: Nashwa Mohammed Ibrahiem, MD, Al-Azhar Unversity; Study Chair: Wafaa Abd Ali Elhadi, MD, Al-Azhar Unversity; Principal Investigator: Hanaa Said Rashed, MD, National liver institute Menofia University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; Dexmedetomidine; Dexamethasone; Brachial Plexus Blockade; Mangesuim sulphate
• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexamethasone; Dexmedetomidine
• Other Study ID Numbers: RHDIRB2018122002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No