An interventional study of Block with lidocaine for SAM and PEC I block in Breast Cancer and Anesthesia, sponsored by Hospital Sirio-Libanes. Active, not recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Hospital Sirio-Libanes · Not applicable, Interventional, and Treatment
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.
In breast surgery, regional anesthesia associated with general anesthesia during surgery has shown great results for the post-operative pain management, prevention of tumor recurrence and development of neuropathic pain. It has been shown that regional anesthesia attenuates the inflammatory response and systemic changes postoperatively during breast surgeries. Thus, it is important to include an additional analgesic intervention in breast surgery in order to decrease the local inflammatory response and the postoperative pain. Thus, 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. 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. 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.
Hospital Sirio-Libanes is the lead sponsor of 44 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Interventions: include pain assessment, inflammatory response and opioid consumption.
Drug: Block with lidocaine for SAM and PEC I block
Interventions: include pain assessment, inflammatory response and opioid consumption.
Drug: 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.
Also known as: Neuropathic pain
Patient´s Pain assessment
The postoperative pain will be assessed using the Visual Analogue Scale pain in the recovery room and 24 hours after surgery.
Time frame: 24 hours
Opioid consumption
The opioid consumption will be evaluated during and 24h after breast surgery
Time frame: 24 hours
Cytokines
Blood sample will be collected for determination of serum cytokines before surgery and 24 hours after the surgery.
Time frame: 24 hours
Development of chronic pain
The development of chronic pain 12 months after mastectomy will be evaluated using the following scales: Douleur Neuropathique-4 - DN-4 (scores 4 or more indicates neuropathic character), Numeric Rating Scale - NRS ranging from 0 (no pain) -10 (worst pain) and Short-Form Health Survey (SF-36) ranging from zero (worst) to 100 (best score).
Time frame: 1 year
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Hospital Sirio-Libanes