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.
Age of 18 years or over, but less than 85 years;
Scheduled to undergo mastectomy for primary unilateral breast cancer.
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;
Parallel
Erector spinae plane block
Procedure/SurgeryPrior 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).
Control group
Procedure/SurgeryGeneral anesthesia alone.
Incidence of chronic postsurgical pain (CPSP) at 6 months after surgery
CPSP is defined as pain persisting for at least three months after surgery that was not present before surgery or that had different characteristics, and other possible causes of pain were excluded (e.g., cancer recurrence, infection).
Progression-free survival (long-term outcomes)
Progression-free survival is defined as the time from randomization to disease progression (recurrence or metastasis) or death from any cause.
Incidence of chronic postsurgical pain (CPSP) at 3 and 12 months after surgery
CPSP is defined as pain persisting for at least three months after surgery that was not present before surgery or that had different characteristics, and other possible causes of pain were excluded (e.g., cancer recurrence, infection).
Incidence of neuropathic pain at 3, 6, and 12 months after surgery
Neuropathic pain is defined as a score at or above 0 on the Neuropathic Pain Questionnaire Short-form. The questionnaire contains three items, i.e., tingling pain, numbness, and increased pain due to touch. Each item is scored from 0 (no pain) to 100 (worst pain imaginable), and multiplied by a discriminant function coefficient (tingling: 0.017, numbness: 0.015, increased pain to touch: 0.011). The total sum of these is added to a constant value (-1.302) to yield a final score ranging from -1.302 to 2.998, with a cutoff of ≥0 suggesting neuropathic pain.
Overall survival (long-term outcome)
Overall survival is defined as the time from randomization to death from any cause.
Event-free survival (long-term outcome)
Event-free survival is defined as the time from randomization to tumor recurrence/metastasis, re-hospitalization for any reason, or death from any cause.
Pain intensity within the first 3 postoperative days
Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain, both at rest and with movement.
Subjective sleep quality within the first 3 postoperative days
Subjective sleep quality is assessed with the numeric rating scale, an 11-point scale where 0=the best sleep quality and 10=the worst sleep quality.
Patient-reported quality of recovery
Patient-reported quality of recovery is assessed with the Quality of Recovery-15 scale (QoR-15 scale, a 15-item scale to assess the patients' postoperative recovery in physical comfort, emotional state, physical independence, psychological support and pain. For each item, the score ranges from 0 to 10. The total score ranges from 0 to 150, with higher score indicating better recovery).
Length of stay in hospital after surgery
Length of stay in hospital after surgery
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Peking University First Hospital
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
