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Magnesium as Adjuvant for Sciatic Block (Mg)

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ClinicalTrials.gov Identifier: NCT02198547
Recruitment Status : Unknown
Verified March 2014 by Massimiliano Carassiti, Campus Bio-Medico University.
Recruitment status was:  Recruiting
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Massimiliano Carassiti, 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.

Condition or disease Intervention/treatment Phase
Hallux Valgus Drug: Magnesium Sulfate Drug: Ropivacaine Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Magnesium as Adjuvant to Ropivacaine for Sciatic Block at Popliteal Level.
Study Start Date : March 2014
Actual Primary Completion Date : March 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ropivacaine Magnesium sulfate

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
Mg used with ropivacaine for sciatic nerve blick

Active Comparator: Ropivacaine
Patients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG
Drug: Ropivacaine
Ropivacaine 7,5 mg/ml used for sciatic nerve block




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Post-operative pain [ Time Frame: 3 hours ]
    We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale

  2. Post-operative analgesic consumption [ Time Frame: till 24 hours ]
    We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.

  3. Post-operative pain [ Time Frame: 6 hours ]
    Evaluation of pain with NRS scale

  4. post-operative pain [ Time Frame: 12 hours ]
    Evaluation of pain with NRS scale

  5. Post-operative pain [ Time Frame: 24 hours ]
    Evaluation of pain with NRS scale


Other Outcome Measures:
  1. Patients' approval [ Time Frame: At 24 hours ]
    We evaluate the grade of approval of patients with a questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • given consent
  • allux valgus correction surgery

Exclusion Criteria:

  • allergy to local anesthetic
  • infection in the site of puncture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198547


Contacts
Contact: Massimiliano Carassiti, MD +3906225411181 m.carassiti@unicampus.it

Locations
Italy
Campus Bio-Medico Recruiting
Rome, Italy, 00128
Contact: Massimiliano Carassiti, MD    +3906225411181    m.carassiti@unicampus.it   
Principal Investigator: Massimiliano Carassiti, MD         
Sub-Investigator: Benedetta Galli, MD         
Sub-Investigator: Michelangelo Vitiello, MD         
Campus Bio-Medico Recruiting
Rome, Italy, 00128
Contact: Massimiliano Carassiti, MD    +3906225411181    m.carassiti@unicampus.it   
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
Principal Investigator: Massimiliano Carassiti, MD Campus Bio Medico

Publications:
Responsible Party: Massimiliano Carassiti, MD, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT02198547     History of Changes
Other Study ID Numbers: CarGalMg
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: March 2014

Keywords provided by Massimiliano Carassiti, Campus Bio-Medico University:
Local anesthetic adjuvant,
Magnesium solfatus,
Sciatic block

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Ropivacaine
Magnesium Sulfate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents