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

NCT02647385 | Active Not Recruiting DMC

• 1 other identifier: HSL 2015-90
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Anesthesia

Keywords

serratus anterior plane block; pectoral nerve block; breast surgery; cancer; analgesia; inflammatory cytokines

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (3)

• Opioid consumption

  24 hours

• Cytokines

  24 hours

• Development of chronic pain

  1 year

Study Arms (2)

General Anesthesia

EXPERIMENTAL

Interventions: include pain assessment, inflammatory response and opioid consumption.

Drug: Block with lidocaine for SAM and PEC I block

General Anesthesia SAM and PEC I block

EXPERIMENTAL

Interventions: include pain assessment, inflammatory response and opioid consumption.

Drug: Block with lidocaine for SAM and PEC I block

Interventions

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.

Also known as: Neuropathic pain

General Anesthesia; General Anesthesia SAM and PEC I block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society Anesthesiology (ASA) Scale I and II patients
• Patients submitted to breast cancer
• informed consent signature

You may not qualify if:

• Patients with chronic pain
• Local anesthesia reaction/allergy

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Sírio-Libanês

São Paulo, 01308050, Brazil

Location

Related Publications (5)

• Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.

  PMID: 25009196 BACKGROUND

• Munoz M, Rosso M, Casinello F, Covenas R. Paravertebral anesthesia: how substance P and the NK-1 receptor could be involved in regional block and breast cancer recurrence. Breast Cancer Res Treat. 2010 Jul;122(2):601-3. doi: 10.1007/s10549-010-0850-y. Epub 2010 Mar 24. No abstract available.

  PMID: 20333544 BACKGROUND

• Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

  PMID: 23923989 BACKGROUND

• Matsumoto M, Flores EM, Kimachi PP, Gouveia FV, Kuroki MA, Barros ACSD, Sampaio MMC, Andrade FEM, Valverde J, Abrantes EF, Simoes CM, Pagano RL, Martinez RCR. Benefits in radical mastectomy protocol: a randomized trial evaluating the use of regional anesthesia. Sci Rep. 2018 May 18;8(1):7815. doi: 10.1038/s41598-018-26273-z.

  PMID: 29777144 RESULT

• Flores EM, Gouveia FV, Matsumoto M, Bonacif THFS, Kuroki MA, Antunes GF, Campos ACP, Kimachi PP, Campos DO, Simoes CM, Sampaio MMC, Andrade FEM, Valverde J, Barros ACSD, Pagano RL, Martinez RCR. One year follow-up on a randomized study investigating serratus anterior muscle and pectoral nerves type I block to reduced neuropathic pain descriptors after mastectomy. Sci Rep. 2023 Mar 21;13(1):4591. doi: 10.1038/s41598-023-31589-6.

  PMID: 36944694 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Agnosia

Interventions

Dental Occlusion; Lidocaine; S-Adenosylmethionine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Luiz Fernando Reis, PhD

  Hospital Sirio-Libanes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS, PhD

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 6, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

BR (1)