Breast Cancer, Postoperative Pain, Acute
Conditions
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
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.
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
Ultrasound-guided placement of a catheter in the erector spinae plane for continuous regional analgesia.
DRUGRopivacaine
Local anesthetic administered via continuous infusion through the erector spinae plane catheter for postoperative analgesia.
Sponsors
Aldy Aldy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers will not be blinded.
Intervention model description
Participants will be randomly assigned to receive continuous erector spinae plane block with ropivacaine or standard analgesia without block in a parallel design
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Nuclear Factor Kappa B Levels From Baseline | 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. |
| Opioid Consumption | 24 hours after surgery | Total opioid consumption within the first 24 hours after surgery, converted to morphine equivalent dose. |
| Quality of Recovery | 24 hours after surgery | Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, with higher scores indicating better recovery. |
| Postoperative Nausea and Vomiting | 24 hours after surgery | Incidence of postoperative nausea and vomiting within the first 24 hours after surgery. |
Countries
Indonesia
Contacts
CONTACTAldy Aldy, MD
CONTACTI Gusti Ngurah Mahaalit Aribawa, MD
PRINCIPAL_INVESTIGATORAldy Aldy, MD
Udayana University
Outcome results
None listed