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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Erector Spinae Plane Block | Procedure | Ultrasound-guided placement of a catheter in the erector spinae plane for continuous regional analgesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nuclear Factor Kappa B Levels From Baseline | 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. | Baseline and 24 hours after surgery |
| Opioid Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aldy Aldy, MD | Contact | +6285221222111 | aldychen94@gmail.com | |
| I Gusti Ngurah Mahaalit Aribawa, MD | Contact | +62811396811 | mahaalit@unud.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Aldy Aldy, MD | Udayana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ngoerah Hospital | Denpasar | Bali | 80113 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37601522 | Background | 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. | |
| 27501016 | Background |
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Individual participant data (IPD) will not be shared due to the presence of sensitive patient information and to ensure the confidentiality and privacy of research subjects in accordance with ethical guidelines.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Participants will be randomly assigned to receive continuous erector spinae plane block with ropivacaine or standard analgesia without block in a parallel design
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Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers will not be blinded.
| Ropivacaine | Drug | Local anesthetic administered via continuous infusion through the erector spinae plane catheter for postoperative analgesia. |
|
Total opioid consumption within the first 24 hours after surgery, converted to morphine equivalent dose. |
| 24 hours after surgery |
| Quality of Recovery | Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, with higher scores indicating better recovery. | 24 hours after surgery |
| Postoperative Nausea and Vomiting | Incidence of postoperative nausea and vomiting within the first 24 hours after surgery. | 24 hours after surgery |
| 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. |
| 40584511 | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |