Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients
Recruiting · NCT05494502 · Interventional (participants receive a specific treatment) · Lead sponsor: Peking University First Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age of 18 years or over, but less than 85 years;
- Scheduled to undergo mastectomy for primary unilateral breast cancer.
Exclusion criteria
- 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.
Where it is running
2 locations listed.
- Peking University First Hospital - Beijing, Beijing Municipality, China
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China