Clinical trial · Interventional
Effect of Continuous Erector Spinae Plane Block With Ropivacaine on Postoperative Pain and NF-κB Levels After Mastectomy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Postoperative Pain, Acute | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous Erector Spinae Plane Block | Procedure | — | UNRESOLVED |
| Ropivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Continuous Erector Spinae Plane Block With Ropivacaine
- description
- Participants will receive continuous erector spinae plane block using ropivacaine via catheter placement under ultrasound guidance, in addition to standard postoperative analgesia.
- interventionNames
- Procedure: Continuous Erector Spinae Plane Block
- Drug: Ropivacaine
- type
- NO_INTERVENTION
- label
- Standard Analgesia Without Block
- description
- 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.
Primary outcomes (1)
- measure
- Postoperative Pain Intensity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDBajpai 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
- BACKGROUNDForero 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
- BACKGROUNDZhang 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