Clinical trial NCT06143020: Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
Official title: Effect of Erector Spinae Plane Block on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mammary Cancer
Erector Spinae Plane Block
Postoperative Pain
Keywords: Mammary Cancer
implant reconstruction
erector spinae plane block
Postoperative Pain
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast reconstruction are becoming more and more popular.But the reconstruction caused greater trauma and more severe postoperative pain.ESPB is a new nerve block method which thought to reduce pain after thoracic and breast surgery.However, there are few studies on radical mastectomy combined breast reconstruction. So, this randomized controlled study is conducted to explore its impact on postoperative pain and thus provide more data guidance for clinical.

Detailed description: Patients: 100 breast cancer patients who are planned radical mastectomy combined breast reconstruction Intervention: General anesthesia + erector spinae plane block Control ： General anesthesia Outcome: NRS(Numerical rating scale) of postoperative pain at the sixth hour Study:RCT

Eligibility criteria: Inclusion Criteria:

* patients scheduled for an radical mastectomy and implant reconstruction surgery
* Patients with American Society of Anesthesiologists (ASA) physical status I-II,
* aged 18-70 years

Exclusion Criteria:

* coagulation disorders,
* known allergy to study drugs,
* obesity (body mass index \> 35 kg/m2),
* infection at the injection site,
* chronic opioid consumption, and an inability to use patient-controlled analgesia (PCA) device,
* patient refuse

Primary outcomes:
measure: Post-operative acute pain score at 6 hours
timeFrame: 6 hours After surgery
Secondary outcomes:
measure: Postoperative quality of recovery score
timeFrame: 24 to 72 hours after the surgery
measure: Post-operative acute pain score
timeFrame: 1h, 12h,24, 48h, 72h after the surgery, separately.
measure: Cumulative opioid consumption after surgery
timeFrame: 48 hours after the surgery
measure: AUC of postoperative pain score
timeFrame: 72 hours after the surgery
Other outcomes:
measure: Number of patients with nausea and vomiting
timeFrame: 24 to 72 hours after the surgery
measure: Intraoperative hemodynamic data
timeFrame: During the whole surgery process.
measure: The number of patients receiving rescue analgesia.
timeFrame: 24 to 72 hours after the surgery
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: