Effect of Continuous Erector Spinae Plane Block With Ropivacaine on Postoperative Pain and NF-κB Levels After Mastectomy

Comparison of Continuous Erector Spinae Plane Block With Ropivacaine Versus No Block on Postoperative Pain, NF-κB Levels, Opioid Consumption, and Quality of Recovery in Patients Undergoing Elective Mastectomy

This study aims to evaluate the effect of continuous erector spinae plane block (CESPB) using ropivacaine on postoperative pain in patients undergoing elective mastectomy. In addition to pain control, this study investigates the impact of CESPB on systemic inflammatory response as measured by nuclear factor kappa B (NF-κB) levels, opioid consumption, and quality of recovery. Patients will be randomly assigned to receive CESPB or standard analgesia without block. Outcomes will be assessed within the first 24 hours after surgery. The findings are expected to provide evidence on the clinical and biological benefits of CESPB as part of multimodal analgesia in breast surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Postoperative Pain, Acute
• Intervention / Treatment: Procedure: Continuous Erector Spinae Plane Block; Drug: Ropivacaine

Detailed Description

Breast cancer is one of the most common malignancies worldwide and frequently requires surgical management in the form of mastectomy. Postoperative pain following mastectomy remains a significant clinical problem, with a substantial proportion of patients experiencing moderate to severe pain. Inadequate pain control is associated with increased opioid consumption, delayed recovery, and a higher risk of developing chronic pain.

The inflammatory response plays an important role in postoperative pain, particularly through the activation of nuclear factor kappa B (NF-κB), a key transcription factor that regulates pro-inflammatory mediators. Increased NF-κB activity has been associated with enhanced nociception and poorer recovery outcomes. Therefore, perioperative strategies that can reduce both pain and inflammatory response are of clinical importance.

Continuous erector spinae plane block (CESPB) is a regional anesthesia technique that provides multidermatomal analgesia by delivering local anesthetic into the fascial plane adjacent to the erector spinae muscle. Compared to single-shot techniques, CESPB using a catheter allows prolonged and stable analgesia. Ropivacaine is commonly used due to its favorable safety profile and potential anti-inflammatory effects.

This study is designed as a randomized controlled trial to compare CESPB using ropivacaine with standard analgesia without block in patients undergoing elective mastectomy. The primary outcome is postoperative pain intensity within 24 hours after surgery. Secondary outcomes include NF-κB levels, opioid consumption, incidence of postoperative nausea and vomiting, and quality of recovery measured using the QoR-15 questionnaire.

By integrating clinical and biomolecular outcomes, this study aims to provide comprehensive evidence regarding the effectiveness of CESPB not only in pain control but also in modulating the inflammatory response and improving postoperative recovery.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aldy Aldy, MD; Phone Number: +6285221222111; Email: aldychen94@gmail.com
• Study Contact Backup: Name: I Gusti Ngurah Mahaalit Aribawa, MD; Phone Number: +62811396811; Email: mahaalit@unud.ac.id

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80113
      • Ngoerah Hospital
      • Contact: Aldy Aldy, MD; Phone Number: +6285221222111; Email: aldychen94@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patients aged 18 to 65 years
• Diagnosed with breast cancer
• Scheduled for elective mastectomy under general anesthesia
• American Society of Anesthesiologists (ASA) physical status I-III
• Able to understand and provide written informed consent
• Body mass index (BMI) 18-29 kg/m²

Exclusion Criteria:

• Contraindications to regional anesthesia
• Contraindications or allergy to ropivacaine or local anesthetics
• Inability to use a visual analog scale (VAS) for pain assessment
• Inability to understand or operate patient-controlled analgesia (PCA)
• History of chronic pain or ongoing infection requiring treatment
• History of chronic analgesic use
• History of autoimmune disease
• Uncontrolled systemic disease

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Erector Spinae Plane Block With Ropivacaine; Participants will receive continuous erector spinae plane block using ropivacaine via catheter placement under ultrasound guidance, in addition to standard postoperative analgesia.	Procedure: Continuous Erector Spinae Plane Block; Ultrasound-guided placement of a catheter in the erector spinae plane for continuous regional analgesia.; Drug: Ropivacaine; Local anesthetic administered via continuous infusion through the erector spinae plane catheter for postoperative analgesia.
No Intervention: Standard Analgesia Without Block; Participants will receive standard postoperative analgesia according to institutional protocol, including oral paracetamol, intravenous ketorolac and opioid-based analgesia (patient-controlled analgesia with morphine), without erector spinae plane block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity	Postoperative pain intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where higher scores indicate greater pain.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Nuclear Factor Kappa B Levels From Baseline	Change in nuclear factor kappa B (NF-κB) levels from baseline to 24 hours after surgery, measured in blood samples to assess systemic inflammatory response.	Baseline and 24 hours after surgery
Opioid Consumption	Total opioid consumption within the first 24 hours after surgery, converted to morphine equivalent dose.	24 hours after surgery
Quality of Recovery	Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, with higher scores indicating better recovery.	24 hours after surgery
Postoperative Nausea and Vomiting	Incidence of postoperative nausea and vomiting within the first 24 hours after surgery.	24 hours after surgery

Collaborators and Investigators

• Sponsor: Aldy Aldy
• Investigators: Principal Investigator: Aldy Aldy, MD, Udayana University

Publications and helpful links

General Publications

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
• Bajpai S, Kumar KS, Patibandla S, Giridhar CM. Ultrasound-guided continuous erector spinae plane block for perioperative opioid sparing analgesia in breast cancer surgery: A randomized controlled trial. Saudi J Anaesth. 2023 Jul-Sep;17(3):327-333. doi: 10.4103/sja.sja_760_22. Epub 2023 Jun 22.
• Zhang X, Xiang GR, Wang ZX, Peng MQ, Li M. Effect of dexmedetomidine-ropivacaine transversus abdominis plane block on analgesia and cognitive impairment risk in colorectal cancer surgery. World J Gastrointest Surg. 2025 Jun 27;17(6):102907. doi: 10.4240/wjgs.v17.i6.102907.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Regional Anesthesia; Quality of Recovery; Ropivacaine; Mastectomy; Opioid Consumption; Erector Spinae Plane Block; Multimodal Analgesia; Continuous Erector Spinae Plane Block; Nuclear Factor Kappa B
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pain, Postoperative; Breast Neoplasms; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine
• Other Study ID Numbers: CESPB-ALD-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to the presence of sensitive patient information and to ensure the confidentiality and privacy of research subjects in accordance with ethical guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No