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

NCT ID: NCT02647385

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2026-02-28

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.

Conditions

Breast Cancer; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

General Anesthesia

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

Group Type: EXPERIMENTAL

Block with lidocaine for SAM and PEC I block

Intervention Type: 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.

General Anesthesia SAM and PEC I block

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

Group Type: EXPERIMENTAL

Block with lidocaine for SAM and PEC I block

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Neuropathic pain

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sirio-Libanes

OTHER

Sponsor Role: lead

Responsible Party

Raquel Chacon Ruiz Martinez

MS, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luiz Fernando Reis, PhD

Role: STUDY_DIRECTOR

Hospital Sirio-Libanes

Locations

Hospital Sírio-Libanês

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 25009196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20333544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23923989 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29777144 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36944694 (View on PubMed)

Other Identifiers

HSL 2015-90

Identifier Type: -

Identifier Source: org_study_id