Impact of Erector Spinae Plane Block With Adjuvant Dexmedetomidine on Chronic Postsurgical Pain in Breast Cancer Patients: a Two-center Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Age of 18 years or over, but less than 85 years;

• Scheduled to undergo mastectomy for primary unilateral breast cancer.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Qiongfang Wu, M.D.
wuqf91@163.com
+8618310161109
Backup
Dong-Xin Wang, M.D., Ph.D.
wangdongxin@hotmail.com
+86 13910731903
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2027-07
Participants
Target number of participants: 1206
Treatments
Experimental: Erector spinae plane block group
Prior to general anesthesia, ultrasound guided erector spinae plane block (ESPB; performed with 0.5% ropivacaine 35 ml with dexmedetomidine 1microgram/kg) is performed at T2 level (15 ml) and T4 level (20 ml).
Sham_comparator: Control group
General anesthesia alone.
Sponsors
Collaborators: Peking University Cancer Hospital & Institute
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov