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Clinical Trials in Brazil / NCT02647385
Active, not recruiting Not applicable

Pain Control in Breast Surgery: Analgesia, Opioid Consumption and Inflammatory Response Evaluation

NCT02647385 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2015-12
Last updated
2024-10-08

Condition(s) studied

Breast CancerAnesthesia

Investigational drug(s) / intervention(s)

Block with lidocaine for SAM and PEC I block

Block with lidocaine for SAM and PEC I block: Patients could be submitted to general anesthesia or general anesthesia associated with SAM and PEC I block with lidocaine before mastectomy. Interventions: include pain assessment, inflammatory response and opioid consumption.

Study summary

The serratus anterior muscle plane (SAM) block associated with pectoral nerve block type I (PEC I) may be a safe and effective alternative for the intraoperative of breast surgery, since there is evidence of pain reduction. However, correlation between regional anesthesia, postoperative pain and inflammatory response in breast surgery has not been demonstrated. The aim of this study is to compare the standard intravenous analgesia versus systemic analgesia associated with the SAM block and PEC I during breath cancer surgery. The following parameters will be evaluated: consumption of opioid intra and post-operative; post-operative pain and release of plasma inflammatory cytokines. It is a clinical prospective, randomized and controlled study. 50 individuals will be randomly divided into two groups. A group of patients receive general anesthesia during surgery and intravenous analgesia after the surgery and another group will receive general anesthesia associated with SAM and PEC I block during intraoperative and postoperative systemic analgesia. The postoperative pain will be assessed using the Visual Analogue Scale pain in the recovery room and 24 hours after surgery. Blood sample will be collected for determination of serum cytokines before surgery and 24 hours after the surgery. Also, it will be evaluated the development of chronic neuropathic pain 12 months after mastectomy, the use of analgesic medication, quality of life, depressive symptoms, and the levels of interleukin (IL)-1 beta, IL-6, and IL-10 as predictors of pain and depression.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * American Society Anesthesiology (ASA) Scale I and II patients * Patients submitted to breast cancer * informed consent signature Exclusion Criteria: * Patients with chronic pain * Local anesthesia reaction/allergy

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Sírio-Libanês São Paulo Brazil

More Hospital Sirio-Libanes trials in Brazil

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02647385 on ClinicalTrials.gov ↗ ← All trials in Brazil