Magnesium as Adjuvant for Sciatic Block (Mg)

January 28, 2021 updated by: Massimiliano Carassiti, Campus Bio-Medico University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00128
        • Campus Bio-Medico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • given consent
  • allux valgus correction surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Till 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 hours
Post-operative analgesic consumption
Time Frame: till 24 hours
We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.
till 24 hours
Post-operative pain
Time Frame: 6 hours
Evaluation of pain with NRS scale
6 hours
post-operative pain
Time Frame: 12 hours
Evaluation of pain with NRS scale
12 hours
Post-operative pain
Time Frame: 24 hours
Evaluation of pain with NRS scale
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' approval
Time Frame: At 24 hours
We evaluate the grade of approval of patients with a questionnaire
At 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

July 1, 2020

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CarGalMg

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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