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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculity of medicine - Al-Azhar University hospitals | Cairo | Cairo Governorate | 11884 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11873038 | Background | 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. | |
| 11913804 | 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. |
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| 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 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. |
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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. |
| 33209562 | 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. |
| 34041719 | 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. |
| 22207517 | 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. |