Upper Limb SurgeryNCT06949488
Efficacy of Different Medications as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries
A study testing Group A (DT): Dexmedetomidine group, Group B (MG): Magnesium group and Group C (DM): Dexamethasone group in people with Upper Limb Surgery and Brachial Plexus Blockade, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Upper Limb Surgery, Brachial Plexus Blockade
- What is being tested?
- Group A (DT): Dexmedetomidine group, Group B (MG): Magnesium group and Group C (DM): Dexamethasone group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) status of I and II
- undergoing forearm surgeries
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculity of medicine - Al-Azhar University hospitals
Cairo, Cairo Governorate, 11884
About this study
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
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.
Read the 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.
- Conditions
- Upper Limb Surgery, Brachial Plexus Blockade
- Being tested
- Group A (DT): Dexmedetomidine group, Group B (MG): Magnesium group, Group C (DM): Dexamethasone group
- Keywords
- Brachial Plexus Blockade, Mangesuim sulphate, ultrasound, Dexamethasone, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (DT): Dexmedetomidine groupProcedure or surgery
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 B (MG): Magnesium groupProcedure or surgery
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 groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Group C (DM): Dexamethasone group |
What is being measured
The primary outcome is the main question the study is designed to answer.
-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.
Measured: Over 24 hours post operative starting from transeferring the patient to the recovery area.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Over 48 hours post operative starting from transeferring to the recovery area.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Upper Limb SurgeryStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Gaber Saad, Al-Azhar University
- Investigators
- Hend Mostafa Abosaifa, MD, Study director, Al-Azhar UniversityFatma Alzahraa Roshdy Elkemary, MD, Principal investigator, Al-Azhar UnversityNoha Mohamed Elsai, MD, Study chair, Al-Azhar UnversityAin ELmarwa Abdelmonem Abdallah, MD, Principal investigator, Al-Azhar UnversityNashwa Mohammed Ibrahiem, MD, Study chair, Al-Azhar UnversityWafaa Abd Ali Elhadi, MD, Study chair, Al-Azhar UnversityHanaa Said Rashed, MD, Principal investigator, National liver institute Menofia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949488
- Sponsor's protocol ID
- RHDIRB2018122002
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 11873038Kara 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.
PubMed 11913804Herman 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.
PubMed 33209562Zoratto 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.
PubMed 34041719Bruce 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.
PubMed 22207517
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06949488
- Acronym / sponsor ID
- RHDIRB2018122002
- Conditions
- Upper Limb Surgery, Brachial Plexus Blockade
- Keywords
- Brachial Plexus Blockade, Mangesuim sulphate, ultrasound, Dexamethasone, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (DT): Dexmedetomidine group | Experimental | Procedure: Group A (DT): Dexmedetomidine groupA group of 35 participants will receive 18 ml of bupivacaine 0.5% plus dexmedetomidine 100 µg for the supraclavicular block. |
| Group B (MG): Magnesium group | Experimental | Procedure: Group B (MG): Magnesium groupA 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. |
| Group C (DM): Dexamethasone group | Active comparator | Procedure: Group C (DM): Dexamethasone groupA group of 35 participants will receive 18 ml of bupivacaine 0.5% plus dexamethasone 8 mg for the same block. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) status of I and II
- undergoing forearm surgeries
Key exclusion criteria (7 listed)
- coagulopathies
- Local skin lesions
- Pregnancy
- Has a history of significant neurological, psychiatric, or neuromuscular disorders
- Patients refusing participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A (DT): Dexmedetomidine groupThe 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. | Procedure or surgery | Group A (DT): Dexmedetomidine group |
| Group B (MG): Magnesium groupThe 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. | Procedure or surgery | Group B (MG): Magnesium group |
| Group C (DM): Dexamethasone groupThe 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. | Procedure or surgery | Group C (DM): Dexamethasone group |
Primary outcome
-Post operative Visual analogue scale VAS score
Time frame: Over 24 hours post operative starting from transeferring the patient to the recovery area.
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.
9 secondary outcomes
Onst of sensory block
Time frame: Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes
Onset of motor block
Time frame: Complete motor block will be assessed every 5 min up to a maximum of 30 minutes
Duration of the sensory block
Time frame: Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .
duration of the motor block
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
Time frame: From positioning the patient to the block upto 90 minutes from removing the needle
Intraoperative Pulse rate.
Time frame: From positioning the patient to the block upto 90 minutes from removing the needle
Post operative opioid consumption
Time frame: Over 24 hours post operatively started form transferring the patient to the recovery area
Post operative Nausea and vomiting
Time frame: Over 24 hours post operative starting from transferring to the recovery area.
Postoperative transient neurologic symptoms
Time frame: Over 48 hours post operative starting from transeferring to the recovery area.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Background: PubMed 11873038Begon 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.
- Background: PubMed 11913804Kara 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.
- Background: PubMed 33209562Herman 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.
- Background: PubMed 34041719Zoratto 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.
- Background: PubMed 22207517Bruce 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hend Mostafa Abosaifa, MD study director
Al-Azhar University
Fatma Alzahraa Roshdy Elkemary, MD principal investigator
Al-Azhar Unversity
Noha Mohamed Elsai, MD study chair
Al-Azhar Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A (DT): Dexmedetomidine group, Group B (MG): Magnesium group and Group C (DM): Dexamethasone group in people with Upper Limb Surgery and Brachial Plexus Blockade, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Post operative Visual analogue scale VAS score (time frame: Over 24 hours post operative starting from transeferring the patient to the recovery area.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06949488, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.