Clinical trial · Interventional
Pain Control in Breast Surgery: Analgesia, Opioid Consumption and Inflammatory Response Evaluation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Block with lidocaine for SAM and PEC I block | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- General Anesthesia
- description
- Interventions: include pain assessment, inflammatory response and opioid consumption.
- interventionNames
- Drug: Block with lidocaine for SAM and PEC I block
- type
- EXPERIMENTAL
- label
- General Anesthesia SAM and PEC I block
- description
- Interventions: include pain assessment, inflammatory response and opioid consumption.
- interventionNames
- Drug: Block with lidocaine for SAM and PEC I block
Primary outcomes (1)
- measure
- Patient´s Pain assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDBuckley 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
- BACKGROUNDMunoz 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
- BACKGROUNDBlanco 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
- RESULTMatsumoto 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
- DERIVEDFlores 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