Clinical trial NCT06949488: Efficacy of Different Medications as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries
Official title: Efficacy of Dexmedetomidine, Dexamethasone, and Magnesium Sulphate as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Upper Limb Surgery
Brachial Plexus Blockade
Keywords: Brachial Plexus Blockade
Mangesuim sulphate
ultrasound
Dexamethasone
Dexmedetomidine
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 105
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: -Post operative Visual analogue scale VAS score
timeFrame: Over 24 hours post operative starting from transeferring the patient to the recovery area.
Secondary outcomes:
measure: Onst of sensory block
timeFrame: Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes
measure: Onset of motor block
timeFrame: Complete motor block will be assessed every 5 min up to a maximum of 30 minutes
measure: Duration of the sensory block
timeFrame: Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .
measure: duration of the motor block
timeFrame: 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
measure: Intraoperative mean arterial blood pressure
timeFrame: From positioning the patient to the block upto 90 minutes from removing the needle
measure: Intraoperative Pulse rate.
timeFrame: From positioning the patient to the block upto 90 minutes from removing the needle
measure: Post operative opioid consumption
timeFrame: Over 24 hours post operatively started form transferring the patient to the recovery area
measure: Post operative Nausea and vomiting
timeFrame: Over 24 hours post operative starting from transferring to the recovery area.
measure: Postoperative transient neurologic symptoms
timeFrame: Over 48 hours post operative starting from transeferring to the recovery area.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculity of medicine - Al-Azhar University hospitals
Study officials:
affiliation: Al-Azhar University
name: Hend Mostafa Abosaifa, MD
role: STUDY_DIRECTOR
affiliation: Al-Azhar Unversity
name: Fatma Alzahraa Roshdy Elkemary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar Unversity
name: Noha Mohamed Elsai, MD
role: STUDY_CHAIR
affiliation: Al-Azhar Unversity
name: Ain ELmarwa Abdelmonem Abdallah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar Unversity
name: Nashwa Mohammed Ibrahiem, MD
role: STUDY_CHAIR
affiliation: Al-Azhar Unversity
name: Wafaa Abd Ali Elhadi, MD
role: STUDY_CHAIR
affiliation: National liver institute Menofia University
name: Hanaa Said Rashed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.