NCT02198547

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

6.3 years

First QC Date

March 17, 2014

Last Update Submit

August 22, 2024

Conditions

Hallux Valgus

Keywords

Local anesthetic adjuvant,Magnesium solfatus,Sciatic block

Outcome Measures

Primary Outcomes (1)

  • 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

    Till 24 hours

Secondary Outcomes (5)

  • Post-operative pain

    3 hours

  • Post-operative analgesic consumption

    till 24 hours

  • Post-operative pain

    6 hours

  • post-operative pain

    12 hours

  • Post-operative pain

    24 hours

Other Outcomes (1)

  • Patients' approval

    At 24 hours

Study Arms (2)

Ropivacaine Magnesium sulfate

EXPERIMENTAL

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

Ropivacaine

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Interventions

Magnesium SulfateDRUG

Mg used with ropivacaine for sciatic nerve blick

Ropivacaine Magnesium sulfate
RopivacaineDRUG

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

Ropivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • given consent
  • allux valgus correction surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Bio-Medico

Rome, 00128, Italy

Location

Related Publications (5)

  • 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.

    PMID: 22012543BACKGROUND

  • 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.

    PMID: 22696144BACKGROUND

  • 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.

    PMID: 23094900BACKGROUND

  • 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.

    PMID: 23138572BACKGROUND

  • 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.

    PMID: 24534592BACKGROUND

MeSH Terms

Conditions

Hallux Valgus

Interventions

Magnesium SulfateRopivacaine

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Massimiliano Carassiti, MD

    Campus Bio Medico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 17, 2014

First Posted

July 23, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2020

Study Completion

September 1, 2022

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations

IT(1)