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

• Register: ClinicalTrials.gov
• Last refreshed on: 31 August 2015
• Main ID: NCT02309879
• Date of registration: 28/11/2014
• Prospective Registration: No
• Primary sponsor: Hospital de Base
• Public title: Effect of Infusion of Lidocaine, Magnesium and Remifentanil Perioperatively in Patients Undergoing Mastectomy
• Scientific title: Effect of Intravenous Infusion of Lidocaine, Magnesium Sulphate and Remifentanil Perioperatively in Patients Undergoing Mastectomy: a Prospective, Randomized and Double-blind Study
• Date of first enrolment: August 2014
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02309879
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Brazil

Contacts

• Name: Fabricio T Mendonca, MD, TSA
• Affiliation: Hospital de Base do Distrito Federal, Brazil

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female patients scheduled for elective surgery performed mastectomy;

- Physical Status P1 and P2 of the American Society of Anesthesiology (ASA);

Exclusion Criteria:

- 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;



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Postoperative Pain

Intervention(s)

Drug: Magnesium sulphate and Lidocaine infusion

Drug: Magnesium sulphate infusion

Drug: Remifentanil infusion

Drug: Lidocaine infusion

Primary Outcome(s)

Analgesics consumption in post-operative [Time Frame: Within the first 24 hours after surgery]

Secondary Outcome(s)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: Within the first 24 hours after surgery]

Pain Scores on the Visual Analog Scale [Time Frame: Within the first 24 hours after surgery]

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: During the surgery]

Pain Scores on the Verbal Rating Scale [Time Frame: Within the first 24 hours after surgery]

Anesthetic consumption during surgery [Time Frame: During the surgery]

Secondary ID(s)

LidovsMgvsRemi

Source(s) of Monetary Support

Please refer to primary and secondary sponsors