PainPhase 2MgNCT02752334
Magnesium Sulphate in the Ultrasound-guided Supraclavicular Brachial Plexus Block
A Phase 2 study testing Magnesium Sulphate in people with Pain, run by Magrabi Eye & Ear Hospital at 1 site in Egypt.
Trial summary
This study evaluated the motor and sensory block duration and the postoperative analgesic effects of adding Magnesium Sulphate to bupivacaine in the ultrasound-guided supraclavicular brachial plexus block Anesthesia. Motor and sensory block duration were considered as a primary endpoint. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Magnesium Sulphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - ASA physical status I to II,
- - Patients listed for elective forearm or hand surgery using supraclavicular brachial plexus block anesthesia
Who cannot join
- 1 - evidence of severe cardiovascular, renal, or hepatic diseases, preexisting neurological or psychiatric illnesses.
- 2- patients have allergy to the study drugs. 3 - patients who have any contraindications to brachial plexus block anesthesia.
- 4- pregnant or lactating women, or 5- if the BMI was > 35 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect on Outcome of Adding Magnesium Sulphate to Bupivacaine in the Ultrasound-guided Supraclavicular Brachial Plexus Block Anesthesia
This study evaluated the motor and sensory block duration and the postoperative analgesic effects of adding Magnesium Sulphate to bupivacaine in the ultrasound-guided supraclavicular brachial plexus block Anesthesia. Motor and sensory block duration were considered as a primary endpoint.
Read the detailed description
The supraclavicular approach to the brachial plexus provides more consistent and effective regional anesthesia to the upper extremity than other approaches to brachial plexus blockade. However, the fear of pneumothorax is often cited by anesthetists as a reason to avoid this approach. With increasing affirmation on patient safety and better patient outcomes, ultrasound guided regional anesthesia (UGRA) is becoming more widely popular. Ultrasound provides clinicians with a real time image suitable for visualizing anatomical structures, needle placement, and local anesthetic spread. Ultrasound-guidance to supraclavicular brachial plexus block has shown to increase success rates, reduce the volume of local anesthetic (LA) used and has the potential to minimize the risk of complications.
Although there are many treatment choices for postoperative pain, a gold standard has not been established. Prolonging the duration of peripheral nerve blocks using long-acting Local Anesthesia or perineural catheters can be used. However, perineural catheters are more time-consuming, costly, has possible higher complication rates (e.g. Infection), and needs more postoperative care.
Several adjuvants such as fentanyl, alpha-2 adrenergic agonists (clonidine or dexmedetomidine), tramadol, and magnesium have been used to extend the duration of peripheral nerve blocks. 5-7 Magnesium has antinociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells. Calcium influx leads to a sequence of central sensitization such as windup phenomenon and long term potentiation which are crucial mechanisms that determine the duration and intensity of post-operative pain. Magnesium prevents central sensitization triggered by peripheral nociceptive stimulation in response to painful stimuli.
The investigators designed this study to evaluate the effect of adding magnesium sulphate to bupivacaine in the ultrasound-guided supraclavicular brachial plexus block anesthesia. The sensory and motor block durations were evaluated as primary endpoints and the postoperative analgesic effects as a secondary endpoint.
- Conditions
- Pain
- Being tested
- Magnesium Sulphate
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulphateDrug
Also called Bupivacaine HCL 0.5%
Magnesium has antinociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells.
| Study group | Role | What they receive |
|---|---|---|
| group Bupivacaine | No intervention | patients will receive 23 mL of Bupivacaine HCL 0.5% (Marcaine, 5 mg per mL; Hospira, USA) in addition to 2 mL normal saline using Ultrasound-guided Supraclavicular Brachial Plexus Block |
| group Bupivacaine Magnesium | Active comparator | patients will receive 23 mL of Bupivacaine HCL 0.5% in addition to 2 mL (100 mg) Magnesium Sulphate (Magnesium Sulphate 50 %, 500 mg per mL; Hospira, USA) diluted with normal saline. using Ultrasound-guided Supraclavicular Brachial Plexus Block Receives: Drug: Magnesium Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensory block duration (the time interval between the end of local anesthetic administration and restoration of normal sensation) were evaluated as primary endpoint
extended
Measured: 12 hours
Secondary outcomes (1)
the postoperative analgesic effects (the time interval between the end of local anesthetic administration and the first analgesia given) as a secondary endpoint.
improved
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionFeb 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magrabi Eye & Ear Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf M Ghali, Magrabi Eye & Ear Hospital
- Investigators
- Ashraf M Ghali, Phd, Study chair, Magrabi Eye & Ear Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752334
- Sponsor's protocol ID
- MEEC-IRB-2016-1
- Acronym
- Mg
- Status last verified
- Mar 2019
- First submitted
- 3 Mar 2016
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: yes
Publications
Tran DQ, Russo G, Munoz L, Zaouter C, Finlayson RJ. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular, and axillary brachial plexus blocks. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):366-71. doi: 10.1097/AAP.0b013e3181ac7d18.
PubMed 19574871
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Outcome of Adding Magnesium Sulphate to Bupivacaine in the Ultrasound-guided Supraclavicular Brachial Plexus Block Anesthesia
- ClinicalTrials.gov ID
- NCT02752334
- Acronym / sponsor ID
- Mg / MEEC-IRB-2016-1
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Magrabi Eye & Ear HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 26 Apr 2016 (estimated)
- 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 evaluated the motor and sensory block duration and the postoperative analgesic effects of adding Magnesium Sulphate to bupivacaine in the ultrasound-guided supraclavicular brachial plexus block Anesthesia. Motor and sensory block duration were considered as a primary endpoint.
Detailed description
The supraclavicular approach to the brachial plexus provides more consistent and effective regional anesthesia to the upper extremity than other approaches to brachial plexus blockade. However, the fear of pneumothorax is often cited by anesthetists as a reason to avoid this approach. With increasing affirmation on patient safety and better patient outcomes, ultrasound guided regional anesthesia (UGRA) is becoming more widely popular. Ultrasound provides clinicians with a real time image suitable for visualizing anatomical structures, needle placement, and local anesthetic spread. Ultrasound-guidance to supraclavicular brachial plexus block has shown to increase success rates, reduce the volume of local anesthetic (LA) used and has the potential to minimize the risk of complications.
Although there are many treatment choices for postoperative pain, a gold standard has not been established. Prolonging the duration of peripheral nerve blocks using long-acting Local Anesthesia or perineural catheters can be used. However, perineural catheters are more time-consuming, costly, has possible higher complication rates (e.g. Infection), and needs more postoperative care.
Several adjuvants such as fentanyl, alpha-2 adrenergic agonists (clonidine or dexmedetomidine), tramadol, and magnesium have been used to extend the duration of peripheral nerve blocks. 5-7 Magnesium has antinociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells. Calcium influx leads to a sequence of central sensitization such as windup phenomenon and long term potentiation which are crucial mechanisms that determine the duration and intensity of post-operative pain. Magnesium prevents central sensitization triggered by peripheral nociceptive stimulation in response to painful stimuli.
The investigators designed this study to evaluate the effect of adding magnesium sulphate to bupivacaine in the ultrasound-guided supraclavicular brachial plexus block anesthesia. The sensory and motor block durations were evaluated as primary endpoints and the postoperative analgesic effects as a secondary endpoint.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group Bupivacaine | No intervention | –patients will receive 23 mL of Bupivacaine HCL 0.5% (Marcaine, 5 mg per mL; Hospira, USA) in addition to 2 mL normal saline using Ultrasound-guided Supraclavicular Brachial Plexus Block |
| group Bupivacaine Magnesium | Active comparator | Drug: Magnesium Sulphatepatients will receive 23 mL of Bupivacaine HCL 0.5% in addition to 2 mL (100 mg) Magnesium Sulphate (Magnesium Sulphate 50 %, 500 mg per mL; Hospira, USA) diluted with normal saline. using Ultrasound-guided Supraclavicular Brachial Plexus Block |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- - ASA physical status I to II,
- - Patients listed for elective forearm or hand surgery using supraclavicular brachial plexus block anesthesia
Key exclusion criteria (3 listed)
- 1 - evidence of severe cardiovascular, renal, or hepatic diseases, preexisting neurological or psychiatric illnesses.
- 2- patients have allergy to the study drugs. 3 - patients who have any contraindications to brachial plexus block anesthesia.
- 4- pregnant or lactating women, or 5- if the BMI was > 35 kg/m2.
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 |
|---|---|---|
| Magnesium SulphateAlso: Bupivacaine HCL 0.5%Magnesium has antinociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells. | Drug | group Bupivacaine Magnesium |
Primary outcome
The sensory block duration (the time interval between the end of local anesthetic administration and restoration of normal sensation) were evaluated as primary endpoint
Time frame: 12 hours
extended
1 secondary outcome
the postoperative analgesic effects (the time interval between the end of local anesthetic administration and the first analgesia given) as a secondary endpoint.
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Background: PubMed 19574871Tran DQ, Russo G, Munoz L, Zaouter C, Finlayson RJ. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular, and axillary brachial plexus blocks. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):366-71. doi: 10.1097/AAP.0b013e3181ac7d18.
- Individual participant dataSharing planned: Undecided. yes
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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.
Ashraf M Ghali, Phd study chair
Magrabi Eye & Ear Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium Sulphate in people with Pain, run by Magrabi Eye & Ear Hospital 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 3 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: finished, as of the sponsor's last update on 8 Mar 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The sensory block duration (the time interval between the end of local anesthetic administration and restoration of normal sensation) were evaluated as primary endpoint (time frame: 12 hours). 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 NCT02752334, which also lists 1 linked publication.
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 8 Mar 2019.