Erector spinae plane block for managing pain after breast cancer surgery
Impact of Erector Spinae Plane Block With Adjuvant Dexmedetomidine on Chronic Postsurgical Pain in Breast Cancer Patients: a Two-center Randomized Controlled Trial
This study is testing if a special nerve block combined with a medication can help reduce pain and improve recovery for women after breast cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1206 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT05494502 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the erector spinae plane block (ESPB) combined with dexmedetomidine in reducing chronic postsurgical pain (CPSP) in breast cancer patients undergoing mastectomy. The study aims to determine if this nerve block technique can improve pain management and enhance the quality of life for patients post-surgery. Participants will be randomly assigned to receive either the ESPB intervention or standard care, with outcomes measured over time to assess pain levels and overall recovery. The trial builds on previous findings that suggest regional anesthesia may help prevent CPSP and improve long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 scheduled for unilateral mastectomy due to primary breast cancer.
Not a fit: Patients with previous breast surgeries, chronic opioid dependence, or contraindications to the erector spinae plane block will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of chronic pain in breast cancer patients after surgery, improving their quality of life.
How similar studies have performed: Previous studies have shown promising results with similar nerve block techniques in reducing chronic pain after breast surgery, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Dong-Xin Wang, M.D., Ph.D. — Peking University First Hospital
- Study coordinator: Qiongfang Wu, M.D.
- Email: wuqf91@163.com
- Phone: +8618310161109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.