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Magnesium as Adjuvant for Sciatic Block (Mg)

Primary Purpose

Hallux Valgus

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Magnesium Sulfate
Ropivacaine
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hallux Valgus focused on measuring Local anesthetic adjuvant,, Magnesium solfatus,, Sciatic block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • given consent
  • allux valgus correction surgery

Exclusion Criteria:

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

Sites / Locations

  • Campus Bio-Medico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ropivacaine Magnesium sulfate

Ropivacaine

Arm Description

Locoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg. Sciatic block at popliteal level.

Patients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Post-operative pain
We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale
Post-operative analgesic consumption
We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.
Post-operative pain
Evaluation of pain with NRS scale
post-operative pain
Evaluation of pain with NRS scale
Post-operative pain
Evaluation of pain with NRS scale

Full Information

First Posted
March 17, 2014
Last Updated
January 28, 2021
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT02198547
Brief Title
Magnesium as Adjuvant for Sciatic Block
Acronym
Mg
Official Title
Evaluation of Magnesium as Adjuvant to Ropivacaine for Sciatic Block at Popliteal Level.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Local anesthetic adjuvant,, Magnesium solfatus,, Sciatic block

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine Magnesium sulfate
Arm Type
Experimental
Arm Description
Locoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg. Sciatic block at popliteal level.
Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
Patients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
Mg used with ropivacaine for sciatic nerve blick
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Ropivacaine 7,5 mg/ml used for sciatic nerve block
Primary Outcome Measure Information:
Title
Evaluation of Mg as adjuvant to local anesthetic
Description
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
Secondary Outcome Measure Information:
Title
Post-operative pain
Description
We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale
Time Frame
3 hours
Title
Post-operative analgesic consumption
Description
We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.
Time Frame
till 24 hours
Title
Post-operative pain
Description
Evaluation of pain with NRS scale
Time Frame
6 hours
Title
post-operative pain
Description
Evaluation of pain with NRS scale
Time Frame
12 hours
Title
Post-operative pain
Description
Evaluation of pain with NRS scale
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Patients' approval
Description
We evaluate the grade of approval of patients with a questionnaire
Time Frame
At 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: given consent allux valgus correction surgery Exclusion Criteria: allergy to local anesthetic infection in the site of puncture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimiliano Carassiti, MD
Organizational Affiliation
Campus Bio Medico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campus Bio-Medico
City
Rome
ZIP/Postal Code
00128
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22012543
Citation
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.
Results Reference
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PubMed Identifier
22696144
Citation
Ekmekci 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.
Results Reference
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PubMed Identifier
23094900
Citation
Dogru 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.
Results Reference
background
PubMed Identifier
23138572
Citation
Vastani 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.
Results Reference
background
PubMed Identifier
24534592
Citation
Bailard 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.
Results Reference
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Magnesium as Adjuvant for Sciatic Block

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