Magnesium as Adjuvant for Sciatic Block

NCT ID: NCT02198547

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2022-09-01

Brief Summary

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The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time and can enhance offset time.

Detailed Description

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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.

Conditions

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Hallux Valgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Mg used with ropivacaine for sciatic nerve blick

Ropivacaine

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Ropivacaine 7,5 mg/ml used for sciatic nerve block

Interventions

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Magnesium Sulfate

Mg used with ropivacaine for sciatic nerve blick

Intervention Type DRUG

Ropivacaine

Ropivacaine 7,5 mg/ml used for sciatic nerve block

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* given consent
* allux valgus correction surgery

Exclusion Criteria

* allergy to local anesthetic
* infection in the site of puncture
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Massimiliano Carassiti

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Massimiliano Carassiti, MD

Role: PRINCIPAL_INVESTIGATOR

Campus Bio Medico

Locations

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Campus Bio-Medico

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 22012543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22696144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23094900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23138572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24534592 (View on PubMed)

Other Identifiers

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CarGalMg

Identifier Type: -

Identifier Source: org_study_id

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