Clinical trial

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

Name
HSL 2015-90
Description
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.
Trial arms
Trial start
2015-12-01
Estimated PCD
2024-12-01
Trial end
2025-02-01
Status
Active (not recruiting)
Treatment
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.
Arms:
General Anesthesia, General Anesthesia SAM and PEC I block
Other names:
Neuropathic pain
Size
50
Primary endpoint
Patient´s Pain assessment
24 hours
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-09-29

1 organization

1 product

2 indications

Indication
Breast Cancer
Indication
Anesthesia