An interventional study of Magnesium Sulfate and Ropivacaine in Hallux Valgus, sponsored by Campus Bio-Medico University. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Campus Bio-Medico University · Not applicable, Interventional, and Other
The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time and can enhance offset time.
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.
149 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 111 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Campus Bio-Medico University is the lead sponsor of 84 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Locoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg. Sciatic block at popliteal level.
Drug: Magnesium Sulfate
Patients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG
Drug: Ropivacaine
Mg used with ropivacaine for sciatic nerve blick
Ropivacaine 7,5 mg/ml used for sciatic nerve block
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
Time frame: Till 24 hours
Post-operative pain
We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale
Time frame: 3 hours
Post-operative analgesic consumption
We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.
Time frame: till 24 hours
Post-operative pain
Evaluation of pain with NRS scale
Time frame: 6 hours
post-operative pain
Evaluation of pain with NRS scale
Time frame: 12 hours
Post-operative pain
Evaluation of pain with NRS scale
Time frame: 24 hours
Patients' approval
We evaluate the grade of approval of patients with a questionnaire
Time frame: At 24 hours
Ran from Mar 2014 to primary completion in Jul 2020, 76 months.
Of 49 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's 76 months is above that.
Counting every sponsor, half of 54 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate
Campus Bio-Medico University