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

NCT07562945 | Not Yet Recruiting

• 1 other identifier: CESPB-ALD-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain, Acute; Breast Cancer

Keywords

Erector Spinae Plane Block; Continuous Erector Spinae Plane Block; Ropivacaine; Postoperative Pain; Mastectomy; Nuclear Factor Kappa B; Opioid Consumption; Quality of Recovery; Regional Anesthesia; Multimodal Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Nuclear Factor Kappa B Levels From Baseline

  Baseline and 24 hours after surgery

• Opioid Consumption

  24 hours after surgery

• Quality of Recovery

  24 hours after surgery

• Postoperative Nausea and Vomiting

  24 hours after surgery

Study Arms (2)

Continuous Erector Spinae Plane Block With Ropivacaine

EXPERIMENTAL

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; Drug: Ropivacaine

Standard Analgesia Without Block

NO INTERVENTION

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.

Interventions

Continuous Erector Spinae Plane Block PROCEDURE

Ultrasound-guided placement of a catheter in the erector spinae plane for continuous regional analgesia.

Continuous Erector Spinae Plane Block With Ropivacaine

Ropivacaine DRUG

Local anesthetic administered via continuous infusion through the erector spinae plane catheter for postoperative analgesia.

Continuous Erector Spinae Plane Block With Ropivacaine

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aldy Aldy: lead

Study Sites (1)

Ngoerah Hospital

Denpasar, Bali, 80113, Indonesia

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Aldy Aldy, MD

  Udayana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldy Aldy, MD

CONTACT

+6285221222111; aldychen94@gmail.com

I Gusti Ngurah Mahaalit Aribawa, MD

CONTACT

+62811396811; mahaalit@unud.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to receive continuous erector spinae plane block with ropivacaine or standard analgesia without block in a parallel design

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)