Ngoerah Hospital
Denpasar, Bali, 80113, Indonesia
NCT Number: NCT07562945
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.
Trial opening soon.
Get Notified30 year–65 year
Female
Interventional
Not applicable
Denpasar, Bali, 80113, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided placement of a catheter in the erector spinae plane for continuous regional analgesia.
Local anesthetic administered via continuous infusion through the erector spinae plane catheter for postoperative analgesia.
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.
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.
Time frame: 24 hours after surgery
Total opioid consumption within the first 24 hours after surgery, converted to morphine equivalent dose.
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.
Time frame: 24 hours after surgery
Incidence of postoperative nausea and vomiting within the first 24 hours after surgery.
Contact information is provided by the study sponsor or research team.
Aldy Aldy, MD
CONTACT
I Gusti Ngurah Mahaalit Aribawa, MD
CONTACT
Aldy Aldy
Other
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
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