The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain.
Stephan A Schug, Patricia Lavand'homme, Antonia Barke...
https://pubmed.ncbi.nlm.nih.gov/30586070Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID05494502
Impact of Erector Spinae Plane Block With Adjuvant Dexmedetomidine on Chronic Postsurgical Pain in Breast Cancer Patients: a Two-center Randomized Controlled Trial
Led by Peking University First Hospital · Updated on 2025-07-31
1206
Participants Needed
2
Research Sites
86 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic postsurgical pain (CPSP) occurs in nearly half of patients after breast cancer surgery and can seriously impact physical and emotional health as well as quality of life. Acute pain after surgery is a key factor that increases the risk of developing CPSP. Researchers are studying the effect of a nerve block technique called erector spinae plane block (ESPB) combined with the drug dexmedetomidine on reducing CPSP in breast cancer patients undergoing mastectomy. They will also look at how ESPB affects long-term survival outcomes. The study compares two groups of breast cancer patients having mastectomy: one group receives ultrasound-guided ESPB using 0.5% ropivacaine with dexmedetomidine at specific spine levels before general anesthesia, while the other group receives general anesthesia alone. The nerve block is expected to provide pain relief by targeting nerves in the chest and may reduce persistent pain after surgery. The study is randomized and double-blinded to fairly assess the treatments. Participants will be followed for up to three years after surgery. Researchers will check for chronic postsurgical pain at 3, 6, and 12 months, as well as neuropathic pain and quality of life over time. They will also monitor progression-free survival, overall survival, and event-free survival as long-term outcomes. Assessments include pain evaluation and health status questionnaires to capture the impact of treatments on recovery and well-being.
CONDITIONS
Brief Title
Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age of 18 years or over, but less than 85 years
- Scheduled to undergo mastectomy for primary unilateral breast cancer
You will not qualify if you...
- Previous breast cancer surgery with an incision of >2 cm
- Chronic opioid dependence or long-term intake of analgesic medicines (>3 months)
- 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
- Inability to communicate in the preoperative period because of profound dementia, deafness, language barriers, or end-stage disease
- History of malignant tumor in other organs, or a current combination of malignant tumor of other organs
- 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
- Allergy to ropivacaine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of surgery day
Participants receive either an erector spinae plane block with adjuvant dexmedetomidine prior to general anesthesia or general anesthesia alone during mastectomy surgery.
1 visit (in-person on surgery day)
Long-term Monitoring
Duration - Up to 3 years after surgery
Participants are followed to assess chronic postsurgical pain and long-term outcomes including progression-free survival, overall survival, event-free survival, and quality of life.
Visits at 3, 6, 12 months, and annually up to 3 years after surgery
Trial Site Locations
Total: 2 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
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Research Team
Q
Qiongfang Wu, M.D.
D
Dong-Xin Wang, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Prevalence and intensity of persistent post-surgical pain following breast cancer surgery: a systematic review and meta-analysis of observational studies.
Li Wang, Jared C Cohen, Niveditha Devasenapathy...
https://pubmed.ncbi.nlm.nih.gov/32611524Persistent 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.
Andrea Saporito, José Aguirre, Alain Borgeat...
https://pubmed.ncbi.nlm.nih.gov/31114301Important considerations with respect to reducing the transition from acute to persistent postoperative pain.
Katarina Kojic, Hance Clarke
https://pubmed.ncbi.nlm.nih.gov/33634743A Conceptual Model of Biopsychosocial Mechanisms of Transition from Acute to Chronic Postsurgical Pain in Children and Adolescents.
Jennifer A Rabbitts, Tonya M Palermo, Emily A Lang
https://pubmed.ncbi.nlm.nih.gov/33262642The progression from acute to chronic pain.
Patricia Lavand'homme
https://pubmed.ncbi.nlm.nih.gov/21772141Mechanisms of action of the erector spinae plane (ESP) block: a narrative review.
Ki Jinn Chin, Kariem El-Boghdadly
https://pubmed.ncbi.nlm.nih.gov/33403545Erector spinae plane block: A narrative review with systematic analysis of the evidence pertaining to clinical indications and alternative truncal blocks.
Mohammed Saadawi, Sebastián Layera, Julián Aliste...
https://pubmed.ncbi.nlm.nih.gov/33032124Analgesic efficacy and safety of erector spinae plane block in breast cancer surgery: a systematic review and meta-analysis.
Ying Zhang, Tieshuai Liu, Youfa Zhou...
https://pubmed.ncbi.nlm.nih.gov/33610172Dexmedetomidine Combined with General Anesthesia Provides Similar Intraoperative Stress Response Reduction When Compared with a Combined General and Epidural Anesthetic Technique.
Yun Li, Bin Wang, Li-Li Zhang...
https://pubmed.ncbi.nlm.nih.gov/26991622