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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02647385
• Other study ID #: HSL 2015-90
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: February 2025

Study information

• Verified date: September 2023
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Sírio-Libanês	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View Citation

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. — View Citation

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 anest — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid consumption	The opioid consumption will be evaluated during and 24h after breast surgery	24 hours
Secondary	Cytokines	Blood sample will be collected for determination of serum cytokines before surgery and 24 hours after the surgery.	24 hours
Secondary	Development of chronic pain	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