Pain Control in Breast Surgery: Analgesia, Opioid Consumption and Inflammatory Response Evaluation
- Conditions
- AnesthesiaBreast Cancer
- Interventions
- Drug: Block with lidocaine for SAM and PEC I block
- Registration Number
- NCT02647385
- Lead Sponsor
- Hospital Sirio-Libanes
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- American Society Anesthesiology (ASA) Scale I and II patients
- Patients submitted to breast cancer
- informed consent signature
- Patients with chronic pain
- Local anesthesia reaction/allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description General Anesthesia Block with lidocaine for SAM and PEC I block Interventions: include pain assessment, inflammatory response and opioid consumption. General Anesthesia SAM and PEC I block Block with lidocaine for SAM and PEC I block Interventions: include pain assessment, inflammatory response and opioid consumption.
- Primary Outcome Measures
Name Time Method Patient´s Pain assessment 24 hours The postoperative pain will be assessed using the Visual Analogue Scale pain in the recovery room and 24 hours after surgery.
- Secondary Outcome Measures
Name Time Method Opioid consumption 24 hours The opioid consumption will be evaluated during and 24h after breast surgery
Cytokines 24 hours Blood sample will be collected for determination of serum cytokines before surgery and 24 hours after the surgery.
Development of chronic pain 1 year 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).
Trial Locations
- Locations (1)
Hospital Sírio-Libanês
🇧🇷Sao Paulo, Brazil