An interventional study of Group A (DT): Dexmedetomidine group and Group B (MG): Magnesium group in Upper Limb Surgery and Brachial Plexus Blockade, sponsored by Al-Azhar University. Active, not recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
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.
Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
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 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.
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.
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.
-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.
Time frame: Over 24 hours post operative starting from transeferring the patient to the recovery area.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Over 48 hours post operative starting from transeferring to the recovery area.
Plan to share: Undecided
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Al-Azhar University