Hallux ValgusMgNCT02198547
Magnesium as Adjuvant for Sciatic Block
A study testing Magnesium Sulfate and Ropivacaine in people with Hallux Valgus, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time and can enhance offset time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Magnesium Sulfate and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to 1 Sep 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- given consent
- allux valgus correction surgery
Who cannot join
- allergy to local anesthetic
- infection in the site of puncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Magnesium as Adjuvant to Ropivacaine for Sciatic Block at Popliteal Level.
The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time and can enhance offset time.
Read the detailed description
Patients are randomly divided into two groups: group "M" (Ropivacaina 7,5 mg/ml with Mg 4 mg/Kg)and group"C" (without Mg).
Standard monitoring is applied to each patient in perioperative period. An indipendent observer collect data: time to perform block, sensitivity onset,motor onset, pain during surgery and complication.
In the post-operative period till 24 hours for each patient is evaluated off-set time, pain and analgesic consumption.
- Conditions
- Hallux Valgus
- Being tested
- Magnesium Sulfate, Ropivacaine
- Keywords
- Local anesthetic adjuvant,, Magnesium solfatus,, Sciatic block
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Mg used with ropivacaine for sciatic nerve blick
RopivacaineDrug
Ropivacaine 7,5 mg/ml used for sciatic nerve block
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine Magnesium sulfate | Experimental | Locoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg.
Sciatic block at popliteal level. Receives: Drug: Magnesium Sulfate |
| Ropivacaine | Active comparator | Patients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Mg as adjuvant to local anesthetic
We evaluate if Mg affects onset and offset time of ropivacaine 7,5 mg/ml in sciatic block at popliteal level
Measured: Till 24 hours
Secondary outcomes (5)
Post-operative pain
We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale
Measured: 3 hours
Post-operative analgesic consumption
We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.
Measured: till 24 hours
Post-operative pain
Evaluation of pain with NRS scale
Measured: 6 hours
post-operative pain
Evaluation of pain with NRS scale
Measured: 12 hours
Post-operative pain
Evaluation of pain with NRS scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startMar 2014
- Primary completion1 Jul 2020
- Study completion1 Sep 2022
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 Hallux ValgusStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano Carassiti, Campus Bio-Medico University
- Investigators
- Massimiliano Carassiti, MD, Principal investigator, Campus Bio Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198547
- Sponsor's protocol ID
- CarGalMg
- Acronym
- Mg
- Status last verified
- Aug 2024
- First submitted
- 17 Mar 2014
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.
PubMed 22012543Ekmekci P, Bengisun ZK, Akan B, Kazbek BK, Ozkan KS, Suer AH. The effect of magnesium added to levobupivacaine for femoral nerve block on postoperative analgesia in patients undergoing ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1119-24. doi: 10.1007/s00167-012-2093-4. Epub 2012 Jun 14.
PubMed 22696144Dogru K, Yildirim D, Ulgey A, Aksu R, Bicer C, Boyaci A. Adding magnesium to levobupivacaine for axillary brachial plexus block in arteriovenous fistule surgery. Bratisl Lek Listy. 2012;113(10):607-9. doi: 10.4149/bll_2012_136.
PubMed 23094900Vastani N, Seifert B, Spahn DR, Maurer K. Sensitivities of rat primary sensory afferent nerves to magnesium: implications for differential nerve blocks. Eur J Anaesthesiol. 2013 Jan;30(1):21-8. doi: 10.1097/EJA.0b013e32835949ab.
PubMed 23138572Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.
PubMed 24534592
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Magnesium as Adjuvant to Ropivacaine for Sciatic Block at Popliteal Level.
- ClinicalTrials.gov ID
- NCT02198547
- Acronym / sponsor ID
- Mg / CarGalMg
- Conditions
- Hallux Valgus
- Keywords
- Local anesthetic adjuvant,, Magnesium solfatus,, Sciatic block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 Jul 2014 (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.
The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time and can enhance offset time.
Detailed description
Patients are randomly divided into two groups: group "M" (Ropivacaina 7,5 mg/ml with Mg 4 mg/Kg)and group"C" (without Mg).
Standard monitoring is applied to each patient in perioperative period. An indipendent observer collect data: time to perform block, sensitivity onset,motor onset, pain during surgery and complication.
In the post-operative period till 24 hours for each patient is evaluated off-set time, pain and analgesic consumption.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine Magnesium sulfate | Experimental | Drug: Magnesium SulfateLocoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg. Sciatic block at popliteal level. |
| Ropivacaine | Active comparator | Drug: RopivacainePatients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- given consent
- allux valgus correction surgery
Key exclusion criteria (2 listed)
- allergy to local anesthetic
- infection in the site of puncture
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 SulfateMg used with ropivacaine for sciatic nerve blick | Drug | Ropivacaine Magnesium sulfate |
| RopivacaineRopivacaine 7,5 mg/ml used for sciatic nerve block | Drug | Ropivacaine |
Primary outcome
Evaluation of Mg as adjuvant to local anesthetic
Time frame: Till 24 hours
We evaluate if Mg affects onset and offset time of ropivacaine 7,5 mg/ml in sciatic block at popliteal level
5 secondary outcomes
Post-operative pain
Time frame: 3 hours
Post-operative analgesic consumption
Time frame: till 24 hours
Post-operative pain
Time frame: 6 hours
post-operative pain
Time frame: 12 hours
Post-operative pain
Time frame: 24 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 26 Aug 2024.
- Background: PubMed 22012543Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.
- Background: PubMed 22696144Ekmekci P, Bengisun ZK, Akan B, Kazbek BK, Ozkan KS, Suer AH. The effect of magnesium added to levobupivacaine for femoral nerve block on postoperative analgesia in patients undergoing ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1119-24. doi: 10.1007/s00167-012-2093-4. Epub 2012 Jun 14.
- Background: PubMed 23094900Dogru K, Yildirim D, Ulgey A, Aksu R, Bicer C, Boyaci A. Adding magnesium to levobupivacaine for axillary brachial plexus block in arteriovenous fistule surgery. Bratisl Lek Listy. 2012;113(10):607-9. doi: 10.4149/bll_2012_136.
- Background: PubMed 23138572Vastani N, Seifert B, Spahn DR, Maurer K. Sensitivities of rat primary sensory afferent nerves to magnesium: implications for differential nerve blocks. Eur J Anaesthesiol. 2013 Jan;30(1):21-8. doi: 10.1097/EJA.0b013e32835949ab.
- Background: PubMed 24534592Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.
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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.
Massimiliano Carassiti, MD principal investigator
Campus Bio Medico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and Ropivacaine in people with Hallux Valgus, run by Campus Bio-Medico University at 1 site in Italy.
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 2 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 26 Aug 2024. 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 Italy. 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?
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?
Evaluation of Mg as adjuvant to local anesthetic (time frame: Till 24 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 NCT02198547, 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 26 Aug 2024.