RecruitingNot ApplicableNCT05494502

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

Sponsor

Peking University First Hospital

Enrollment

1,206 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a type of nerve block called an erector spinae plane block (ESP block) — given during mastectomy surgery — can reduce the risk of developing long-term chronic pain after breast cancer surgery. The ESP block numbs nerves in the back to control pain around the chest and surgery area. **You may be eligible if...** - You are between 18 and 85 years old - You are scheduled for a mastectomy for primary, one-sided breast cancer **You may NOT be eligible if...** - You have had previous breast cancer surgery with a significant incision - You have been taking opioid pain medications long-term (more than 3 months) - You have any contraindication to the block, such as infection at the injection site, serious spinal deformity, or history of spinal surgery - You have serious dementia, hearing difficulties, or a language barrier preventing communication - You have another active cancer - You have a history of coronary heart disease, prior heart attack, or heart procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREErector 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).

PROCEDUREControl group

General anesthesia alone.