Comparing the QoR of PECS Block and GA in Breast-conserving Surgery With Sentinel Lymph Node Biopsy

Breast Cancer Clinical Trial

Official title:

Comparing the Quality of Recovery(QoR) of Pectoral Nerves(PECS) Block and General Anesthesia(GA) in Breast-conserving Surgery(BCS) With Sentinel Lymph Node Biopsy(SLNB):A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120439
• Other study ID #: CSYDXSJLHLJSJ-1
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: Fudan University
• Contact: Jun Zhang, PhD
• Phone: 86-21-64175590
• Email: snapzhang[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled trial (RCT) is to assess the Quality of Recovery (QoR) in Breast-conserving Surgery (BCS) with Sentinel Lymph Node Biopsy (SLNB) using Pectoral Nerves (PECS) Block and General Anesthesia (GA). The primary objectives are as follows: First, to determine if the PECS group exhibits better QoR; Second, to investigate if the PECS group experiences less postoperative pain and complications; Third, to examine if the PECS group demonstrates more stable hemodynamics.

Description:

This study is a randomized controlled trial, with a 1:1 ratio for grouping. The experimental group is the T group, receiving Pecs II combined with intercostal nerve block, while the control group is the C group, receiving general anesthesia. The primary outcome measure is the QoR-15 score of the subjects 6 hours after surgery. Based on preliminary results, the control group had a QoR-15 score of 133±8 (n=6), and the experimental group needs to improve by at least 8 points (which is generally considered clinically significant, PMID:27159009). With a two-sided α=0.05 and a power of 99%, accounting for a 20% dropout rate, the final required sample size was calculated to be 96 cases, with 48 cases in each group.

If the proportion of dropout cases is less than 5% and considered "completely random missing," the missing records generated by the dropout cases will be directly excluded. Depending on the specific circumstances, either single imputation or multiple imputation methods will be used.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: April 30, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for breast-conserving surgery with sentinel lymph node biopsy.

• Age between 18 and 70 years.

• Body Mass Index (BMI) < 30 kg/m2.

• American Society of Anesthesiologists (ASA) classification grade I-III.

Exclusion Criteria:

• Contraindications to regional anesthesia: site infection at the puncture site, allergy to local anesthetics, coagulation disorders, or bleeding risks.

• Impaired liver or kidney function.

• Pregnancy, lactation, possibility of pregnancy, or planned pregnancy.

• Preoperative use of analgesic drugs, history of chronic pain, or history of opioid abuse.

• Mental illness.

• Patients who refuse to participate.

• Patients deemed unsuitable for the clinical trial by the researchers.

Related Conditions & MeSH terms

• Breast Cancer
• Breast-Conserving Surgery
• Sentinel Lymph Node Biopsy

Intervention

Combination Product:
• PECS II combined with intercostal nerve blockade;
The patient was in a supine position, and under ultrasound guidance, the needle tip was first placed in the plane between the pectoralis major and minor muscles, and 10ml of 0.3% ropivacaine was injected. The needle was then advanced into the space between the pectoralis minor and serratus anterior muscles, and 20ml of 0.3% ropivacaine was injected. Intercostal nerve blockade: The range of intercostal blockade was determined based on the location of the breast surgery. The needle was inserted into the intercostal space from the posterior axillary line, and 3ml of 0.3% ropivacaine was injected into each intercostal space.
• General anesthesia with laryngeal mask
The C Group underwent general anesthesia induction using TCI propofol 3-3.5µg/ml, TCI remifentanil 1-2ng/ml, sufentanil 0.3µg/kg iv, midazolam 0.05mg/kg iv, and rocuronium 0.6mg/kg iv after loss of consciousness. After muscle relaxation, the laryngeal mask was inserted, and mechanical ventilation was performed with a tidal volume of 6ml/kg. Anesthesia maintenance included propofol 3-4µg/ml and remifentanil 1-2ng/ml.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jun Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative QoR-15 at 2 hours	The 15-item quality of recovery(QoR-15) at 2 hours after the surgery.	2 hours after the surgery
Other	Postoperative QoR-15 at 24 hours	The 15-item quality of recovery(QoR-15) at 24 hours after the surgery.	24 hours after the surgery
Other	Postoperative NRS pain score at 2 hours	Postoperative numeric rating scales pain score at 2 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. 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.	2 hours after the surgery
Other	Postoperative NRS pain score at 24 hours	Postoperative numeric rating scales pain score at 24 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. 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.	24 hours after the surgery
Other	The number of patients requiring additional analgesics	The number of patients requiring additional analgesics for rescue analgesia after the surgery is completed.	24 hours after the surgery
Other	the number of patients who experience intraoperative hypotension.	A systolic blood pressure below 80mmHg is defined as hypotension. Record the number of patients who experience intraoperative hypotension.	24 hours after the surgery
Other	the number of patients who experience intraoperative Bradycardia.	During the surgery and anesthesia process, a heart rate below 45 bpm is defined as intraoperative Bradycardia. Record the number of patients who experience intraoperative Bradycardia.	From the beginning of anesthesia to the end of the surgery.
Other	the number of patients who experience intraoperative Bradycardia.	A heart rate below 45 bpm is defined as Bradycardia. Record the number of patients who experience Bradycardia.	24 hours after the surgery
Other	Proportion of patients experiencing postoperative nausea and vomiting	Proportion of patients experiencing postoperative nausea and vomiting at least once at 24 hours postoperatively.	24 hours after the surgery
Primary	Postoperative QoR-15 at 6 hours	The 15-item quality of recovery(QoR-15) at 6 hours after the surgery.	6 hours after the surgery
Secondary	Postoperative NRS pain score at 6 hours	Postoperative numeric rating scales pain score at 6 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. 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.	6 hours after the surgery
Secondary	the number of patients who experience intraoperative hypotension	During the surgery and anesthesia process, a systolic blood pressure below 80mmHg is defined as intraoperative hypotension. Record the number of patients who experience intraoperative hypotension.	From the beginning of anesthesia to the end of the surgery.
Secondary	Changes in hemodynamics (mean arterial pressure) after the surgical incision.	Monitor the magnitude of hemodynamic changes compared to baseline after the incision. The main comparison is the magnitude of changes in mean arterial pressure between the two groups.	From the beginning of anesthesia to three minutes after the surgical incision.
Secondary	Changes in hemodynamics (heart rate) after the surgical incision.	Monitor the magnitude of hemodynamic changes compared to baseline after the incision. The main comparison is the magnitude of changes in heart rate between the two groups.	From the beginning of anesthesia to three minutes after the surgical incision.