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NCT Number: NCT02647385

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Agnosia Anesthesia Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sírio-Libanês

São Paulo, 01308050, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Block with lidocaine for SAM and PEC I block

Drug

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.

Other names: Neuropathic pain

Primary outcomes

  1. Patient´s Pain assessment

    Time frame: 24 hours

    The postoperative pain will be assessed using the Visual Analogue Scale pain in the recovery room and 24 hours after surgery.

Secondary outcomes

  1. Opioid consumption

    Time frame: 24 hours

    The opioid consumption will be evaluated during and 24h after breast surgery

  2. Cytokines

    Time frame: 24 hours

    Blood sample will be collected for determination of serum cytokines before surgery and 24 hours after the surgery.

  3. Development of chronic pain

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hospital Sirio-Libanes

Other

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2026
First posted
Jan 6, 2016
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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