Clinical trial · Interventional
Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients
Impact of Erector Spinae Plane Block With Adjuvant Dexmedetomidine on Chronic Postsurgical Pain in Breast Cancer Patients: a Two-center Randomized Controlled Trial
- 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)
Chronic postsurgical pain (CPSP) has an incidence of 46% in patients after breast cancer surgery, which seriously affects patients' physiological and psychological function, as well as quality of life. Acute pain is an independent risk factor for persistent pain after surgery. Erector spinae plane block (ESPB) provided excellent perioperative analgesia in patients undergoing breast surgery. Dexmedetomidine as an adjuvant of local anesthetics prolongs the duration of peripheral nerve block and decreases the requirements of postoperative analgesia. The investigators hypothesize that, for breast cancer patients undergoing mastectomy, ESPB (with a combination of 0.5% ropivacaine 35 ml and dexmedetomidine 1 microgram/kg) can reduce the occurrence of CPSP. The purpose of this randomized controlled trial is to investigate the impact of ESPB with adjuvant dexmedetomidine on the incidence of CPSP in breast cancer patients after mastectomy. We will also observe the impact of ESPB on long-term survival in these patients.
Conditions
Conditions (7)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Chronic Pain | — | UNRESOLVED | — |
| Dexmedetomidine | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
| Nerve Block | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
| Prognosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Procedure | — | UNRESOLVED |
| Erector spinae plane block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erector spinae plane block group
- description
- Prior to general anesthesia, ultrasound guided erector spinae plane block (ESPB; performed with 0.5% ropivacaine 35 ml with dexmedetomidine 1microgram/kg) is performed at T2 level (15 ml) and T4 level (20 ml).
- interventionNames
- Procedure: Erector spinae plane block
- type
- SHAM_COMPARATOR
- label
- Control group
- description
- General anesthesia alone.
- interventionNames
- Procedure: Control group
Primary outcomes (2)
- measure
- Incidence of chronic postsurgical pain (CPSP) at 6 months after surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age of 18 years or over, but less than 85 years; 2. Scheduled to undergo mastectomy for primary unilateral breast cancer. Exclusion Criteria: 1. Previous breast cancer surgery with an incision of \>2 cm; 2. Chronic opioid dependence or long-term intake of analgesic medicines (\>3 months); 3. Any contraindication to erector spinae plane block, including intrathoracic infection, infection at the puncture site, cancer invasion of the puncture site, severe spinal deformity, history of spinal surgery, and severe coagulopathy; 4. Inability to communicate in the preoperative period because of profound dementia, deafness, language barriers, or end-stage disease; 5. History of malignant tumor in other organs, or a current combination of malignant tumor of other organs; 6. History of coronary heart disease (diagnosed coronary stenosis, previous myocardial infarction, previous percutaneous coronary intervention or coronary artery bypass grafting); preoperative hepatic or renal impairment (alanine transaminase and/or aspartate transaminase ≥2 times of upper limit of normal, or serum creatinine\>133 µmol/L); history of peptic ulcer or hemorrhage; ASA classification IV or above; 7. Allergy to ropivacaine.
References
Publications (16)
- BACKGROUNDSchug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413. PMID 30586070
- BACKGROUNDWang L, Cohen JC, Devasenapathy N, Hong BY, Kheyson S, Lu D, Oparin Y, Kennedy SA, Romerosa B, Arora N, Kwon HY, Jackson K, Prasad M, Jayasekera D, Li A, Guarna G, Natalwalla S, Couban RJ, Reid S, Khan JS, McGillion M, Busse JW. Prevalence and intensity of persistent post-surgical pain following breast cancer surgery: a systematic review and meta-analysis of observational studies. Br J Anaesth. 2020 Sep;125(3):346-357. doi: 10.1016/j.bja.2020.04.088. Epub 2020 Jun 28. PMID 32611524
- BACKGROUNDSaporito A, Aguirre J, Borgeat A, Perren A, Anselmi L, Poggi R, Minotti B, Cafarotti S, La Regina D, Ceruti S. Persistent postdischarge pain and chronic postoperative pain after breast cancer surgery under general anesthesia and single-shot paravertebral block: incidence, characteristics and impact on quality of life and healthcare costs. J Pain Res. 2019 Apr 16;12:1193-1199. doi: 10.2147/JPR.S195702. eCollection 2019. PMID 31114301
- BACKGROUNDKojic K, Clarke H. Important considerations with respect to reducing the transition from acute to persistent postoperative pain. Expert Opin Pharmacother. 2021 May;22(7):779-782. doi: 10.1080/14656566.2021.1892073. Epub 2021 Feb 26. No abstract available. PMID 33634743
- BACKGROUNDRabbitts JA, Palermo TM, Lang EA. A Conceptual Model of Biopsychosocial Mechanisms of Transition from Acute to Chronic Postsurgical Pain in Children and Adolescents. J Pain Res. 2020 Nov 24;13:3071-3080. doi: 10.2147/JPR.S239320. eCollection 2020. PMID 33262642
- BACKGROUNDLavand'homme P. The progression from acute to chronic pain. Curr Opin Anaesthesiol. 2011 Oct;24(5):545-50. doi: 10.1097/ACO.0b013e32834a4f74.