Erector Spinae Plane Block, Mammary Cancer, Postoperative Pain
Conditions
Keywords
Mammary Cancer, implant reconstruction, erector spinae plane block, Postoperative Pain
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
Interventions
PROCEDUREErector spinae plane block
In the ESPB group, the patients were placed in the lateral decubitus position. The ultrasound probe was located in longitudinal orientation at the level of the T4 spinous process and then placed 3 cm laterally from the midline to the side involved in the surgery. The ultrasound landmarks, T4 transverse process, and the overlying trapezius, rhomboideus, and erector spinae muscles, were identified. Under aseptic conditions, an 80-mm 21-gauge block needle was inserted in-plane at an angle of 30-40° in the cranial-to-caudal direction until the tip contacted the T4 transverse process.After the hydrodissection with 2-3 mL of isotonic saline solution confirmed the correct needle tip position, the intermixture was injected in the interfascial plane between rhomboideus major and erector spinae muscle. Local anesthetic spread in a fascial longitudinal pattern deep to the erector spinae muscle was visualized using ultrasound guidance.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative acute pain score at 6 hours | 6 hours After surgery | 11-point numerical rating scale(0=no pain, 10=worst pain) at 6th hour following the surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative acute pain score | 1h, 12h,24, 48h, 72h after the surgery, separately. | Pain scores at other time points except for the primary outcome. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with no pain and at the right-most end with worst pain imaginable. Pain levels below 4 are considered mild, 4-7 is moderate pain, and anything above 7 is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4. |
| Postoperative quality of recovery score | 24 to 72 hours after the surgery | The QoR-15 will be used to evaluate postoperative quality of recovery from 15 dimensions. The QoR-15 scale is a global measurement of postoperative recovery, consisting of 15 items with 10 points each, with a total score ranging from 0 (QoR very poor) to 150 (QoR very good). |
| Cumulative opioid consumption after surgery | 48 hours after the surgery | Cumulative opioid consumption after surgery |
| AUC of postoperative pain score | 72 hours after the surgery | Area under the curve(AUC) of pain score 72 hours after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| The number of patients receiving rescue analgesia. | 24 to 72 hours after the surgery | The number of patients receiving rescue analgesia. |
| Intraoperative hemodynamic data | During the whole surgery process. | Including mean blood pressure(mmHg), heart rate(beats/min) during the surgery. |
| Number of patients with nausea and vomiting | 24 to 72 hours after the surgery | Number of patients who experienced nausea and vomiting after surgery. |
Countries
China
Outcome results
None listed