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NCT Number: NCT07562945

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

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Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous erector spinae plane block

Procedure

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

Ropivacaine

Drug

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

Primary outcomes

  1. Postoperative Pain Intensity

    Time frame: 24 hours after surgery

    Postoperative pain intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where higher scores indicate greater pain.

Secondary outcomes

  1. Change in Nuclear Factor Kappa B Levels From Baseline

    Time frame: Baseline and 24 hours after surgery

    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.

  2. Opioid Consumption

    Time frame: 24 hours after surgery

    Total opioid consumption within the first 24 hours after surgery, converted to morphine equivalent dose.

  3. Quality of Recovery

    Time frame: 24 hours after surgery

    Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, with higher scores indicating better recovery.

  4. Postoperative Nausea and Vomiting

    Time frame: 24 hours after surgery

    Incidence of postoperative nausea and vomiting within the first 24 hours after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Aldy Aldy, MD

CONTACT

[email protected]

+6285221222111

I Gusti Ngurah Mahaalit Aribawa, MD

CONTACT

[email protected]

+62811396811

Sponsors and collaborators

Lead sponsor

Aldy Aldy

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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