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Completed

NCT Number: NCT02198547

Magnesium as Adjuvant for Sciatic Block

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

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Bio-Medico

Rome, 00128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • given consent
  • allux valgus correction surgery

Exclusion criteria

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

Treatment and study plan

Magnesium sulfate

Drug

Mg used with ropivacaine for sciatic nerve blick

Ropivacaine

Drug

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

Primary outcomes

  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 outcomes

  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 outcomes

  1. Patients' approval

    Time frame: At 24 hours

    We evaluate the grade of approval of patients with a questionnaire

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Evaluation of Magnesium as Adjuvant to Ropivacaine for Sciatic Block at Popliteal Level.

Acronym: Mg

Important dates

Study start
2014
Primary completion
2020
Study completion
2022
First posted
Jul 23, 2014
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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