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

October 7, 2024 updated by: Raquel Chacon Ruiz Martinez, Hospital Sirio-Libanes
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01308050
        • Hospital Sirio-Libanes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: General Anesthesia
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.

Other Names:
  • Neuropathic pain
Experimental: General Anesthesia 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.

Other Names:
  • Neuropathic pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 24 hours
The opioid consumption will be evaluated during and 24h after breast surgery
24 hours
Cytokines
Time Frame: 24 hours
Blood sample will be collected for determination of serum cytokines before surgery and 24 hours after the surgery.
24 hours
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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Investigators

  • Study Director: Luiz Fernando Reis, PhD, Hospital Sirio-Libanes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimated)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSL 2015-90

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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