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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Postoperative Pain Intensity [Time frame: 24 hours after surgery]

Secondary outcome measures (4)

• Change in Nuclear Factor Kappa B Levels From Baseline [Time frame: Baseline and 24 hours after surgery]
• Opioid Consumption [Time frame: 24 hours after surgery]
• Quality of Recovery [Time frame: 24 hours after surgery]
• Postoperative Nausea and Vomiting [Time frame: 24 hours after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Indonesia · 1 center

• Ngoerah Hospital — Denpasar

Publications

• 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. PMID 37601522
• 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. PMID 27501016
• 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. PMID 40584511

Identifiers

NCT: NCT07562945 · CESPB-ALD-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗