Recruiting

Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients

ClinicalTrials.gov IDNCT05494502

PhaseNA

Enrollment1206

SponsorPeking University First Hospital

Age18 Years

SexALL

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Conditions studied

Breast Neoplasms, Mastectomy, Nerve Block, Dexmedetomidine, Pain, Postoperative, Chronic Pain, Prognosis

About this study

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.

Interventions

Procedure: Erector spinae plane block — Prior to general anesthesia, ultrasound guided erector spinae plane block (ESPB; performed with 0.5% ropivacaine 35 ml with dexmedetomidine 1 microgram/kg) is performed at T2 level (15 ml) and T4 level (20 ml).
Procedure: Control group — General anesthesia alone.

Primary outcomes

Incidence of chronic postsurgical pain (CPSP) at 6 months after surgery (At 6 months after surgery)
Progression-free survival (long-term outcomes) (Up to 3 years after surgery)

Eligibility information

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.

Study locations

Peking University First Hospital, Beijing, Beijing Municipality 100034 China
Beijing Cancer Hospital, Beijing, Beijing Municipality 100142 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.