Effect of Infusion of Lidocaine, Magnesium and Remifentanil Perioperatively in Patients Undergoing Mastectomy

NCT02309879 | Completed Phase 4

• 1 other identifier: LidovsMgvsRemi
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the quality of perioperative analgesia of lidocaine, magnesium sulphate and remifentanil in patients undergoing mastectomy

Conditions

Postoperative Pain

Keywords

Intravenous lidocaine; Magnesium sulphate; Mastectomy; Pain

Outcome Measures

Primary Outcomes (1)

• Analgesics consumption in post-operative

  Qualification of pain assessed by the amount of analgesics required postoperatively and the time to request them

  Within the first 24 hours after surgery

Secondary Outcomes (5)

• Pain Scores on the Visual Analog Scale

  Within the first 24 hours after surgery

• Pain Scores on the Verbal Rating Scale

  Within the first 24 hours after surgery

• Anesthetic consumption during surgery

  During the surgery

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  During the surgery

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Within the first 24 hours after surgery

Study Arms (4)

Remifentanil group

ACTIVE COMPARATOR

Patients in remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.

Drug: Remifentanil infusion; Drug: Lidocaine infusion; Drug: Magnesium sulphate infusion; Drug: Magnesium sulphate and Lidocaine infusion

Lidocaine group

ACTIVE COMPARATOR

Patients in lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.

Drug: Remifentanil infusion; Drug: Lidocaine infusion; Drug: Magnesium sulphate infusion; Drug: Magnesium sulphate and Lidocaine infusion

Magnesium group

ACTIVE COMPARATOR

Patients in lidocaine group received an intravenous bolus injection of 50 mg/kg magnesium sulphate followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr.

Drug: Remifentanil infusion; Drug: Lidocaine infusion; Drug: Magnesium sulphate infusion; Drug: Magnesium sulphate and Lidocaine infusion

Magnesium and Lidocaine group

ACTIVE COMPARATOR

Patients received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate

Drug: Remifentanil infusion; Drug: Lidocaine infusion; Drug: Magnesium sulphate infusion; Drug: Magnesium sulphate and Lidocaine infusion

Interventions

Remifentanil infusion DRUG

Patients in Remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.

Also known as: Remifentanil hydrochloride

Lidocaine group; Magnesium and Lidocaine group; Magnesium group; Remifentanil group

Lidocaine infusion DRUG

Patients in Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.

Also known as: Lidocaine hydrochloride

Lidocaine group; Magnesium and Lidocaine group; Magnesium group; Remifentanil group

Magnesium sulphate infusion DRUG

Patients in Magnesium group received an intravenous bolus injection of 50 mg/kg magnesium sulphate plus an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr.

Also known as: Magnesium sulphate

Lidocaine group; Magnesium and Lidocaine group; Magnesium group; Remifentanil group

Magnesium sulphate and Lidocaine infusion DRUG

Patients in Magnesium and Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate

Also known as: Magnesium sulphate, Lidocaine hydrochloride

Lidocaine group; Magnesium and Lidocaine group; Magnesium group; Remifentanil group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients scheduled for elective surgery performed mastectomy;
• Physical Status P1 and P2 of the American Society of Anesthesiology (ASA);

You may not qualify if:

• Patients with less than 18 years and above 75 years of age;
• Patients who are allergic to morphine and / or lidocaine and / or remifentanil and / or magnesium sulphate;
• Patients with chronic pain;
• Patients with severe hepatic disease;
• Patients with severe renal disease;
• Patients with neurological disorders;
• Patients included in other clinical currently or within the past three months under general anesthesia studies;
• Patients who refuse to participate in the study;
• Any other condition that in the opinion of the investigator, may pose a risk to the patient or interfere with the study objectives;

Sponsors & Collaborators

• Hospital de Base: lead

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70680250, Brazil

Location

Related Publications (3)

• De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.

  PMID: 23669270 BACKGROUND

• Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.

  PMID: 21061107 BACKGROUND

• Mendonca FT, Pellizzaro D, Grossi BJ, Calvano LA, de Carvalho LSF, Sposito AC. Synergistic effect of the association between lidocaine and magnesium sulfate on peri-operative pain after mastectomy: A randomised, double-blind trial. Eur J Anaesthesiol. 2020 Mar;37(3):224-234. doi: 10.1097/EJA.0000000000001153.

  PMID: 31977625 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Remifentanil; Lidocaine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Fabricio T Mendonca, MD, TSA

  Hospital de Base do Distrito Federal, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, TSA

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: December 5, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

BR (1)