Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction

Postoperative Pain Clinical Trial

Official title:

Effect of Erector Spinae Plane Block on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06143020
• Other study ID #: ESPB of BCIR 2.0
• Status: Completed
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: March 5, 2024

Study information

• Verified date: January 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 5, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Erector Spinae Plane Block
• Mammary Cancer
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Erector 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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with nausea and vomiting	Number of patients who experienced nausea and vomiting after surgery.	24 to 72 hours after the surgery
Other	Intraoperative hemodynamic data	Including mean blood pressure(mmHg), heart rate(beats/min) during the surgery.	During the whole surgery process.
Other	The number of patients receiving rescue analgesia.	The number of patients receiving rescue analgesia.	24 to 72 hours after the surgery
Primary	Post-operative acute pain score at 6 hours	11-point numerical rating scale(0=no pain, 10=worst pain) at 6th hour following the surgery	6 hours After surgery
Secondary	Postoperative quality of recovery score	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).	24 to 72 hours after the surgery
Secondary	Post-operative acute pain score	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.	1h, 12h,24, 48h, 72h after the surgery, separately.
Secondary	Cumulative opioid consumption after surgery	Cumulative opioid consumption after surgery	48 hours after the surgery
Secondary	AUC of postoperative pain score	Area under the curve(AUC) of pain score 72 hours after surgery	72 hours after the surgery