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Magnesium as Adjuvant for Sciatic Block

Not Applicable
Completed
Conditions
Hallux Valgus
Interventions
Registration Number
NCT02198547
Lead Sponsor
Campus Bio-Medico University
Brief Summary

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • given consent
  • allux valgus correction surgery
Exclusion Criteria
  • allergy to local anesthetic
  • infection in the site of puncture

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
RopivacaineRopivacainePatients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG
Ropivacaine Magnesium sulfateMagnesium SulfateLocoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg. Sciatic block at popliteal level.
Primary Outcome Measures
NameTimeMethod
Evaluation of Mg as adjuvant to local anestheticTill 24 hours

We evaluate if Mg affects onset and offset time of ropivacaine 7,5 mg/ml in sciatic block at popliteal level

Secondary Outcome Measures
NameTimeMethod
Post-operative pain24 hours

Evaluation of pain with NRS scale

post-operative pain12 hours

Evaluation of pain with NRS scale

Post-operative analgesic consumptiontill 24 hours

We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.

Trial Locations

Locations (1)

Campus Bio-Medico

🇮🇹

Rome, Italy

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