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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated October 8, 2024 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Study completion date: Feb 2025 to Feb 2026v6
  2. Notable Primary completion date: Dec 2017 to Dec 2024
    • Study completion date: Feb 2023 to Feb 2025
    v5
  3. Notable Primary endpoint revisedv4 Show 5 more changesShow less
    • Primary completion date: Mar 2018 to Dec 2017
    • Study completion date: Aug 2018 to Feb 2023
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 41 words
    • Publications: 4 to 5
  4. Notable Primary completion date: Aug 2016 to Mar 2018
    • Study completion date: Aug 2017 to Aug 2018
    v3
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Nov 2016 to Aug 2016
    • Site details revised
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT02647385
Lead Sponsor Hospital Sirio-Libanes
Conditions
(from sponsor)
Breast Cancer, Anesthesia
Related terms Agnosia, Breast Neoplasms, Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov