Clinical trial NCT06120439: Comparing the QoR of PECS Block and GA in Breast-conserving Surgery With Sentinel Lymph Node Biopsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Pectoral Nerves Block
Breast-Conserving Surgery
Sentinel Lymph Node Biopsy
Keywords: Pectoral nerves block II
intercostal nerve block
dexmedetomidine
breast-conserving surgery
sentinel lymph node biopsy
quality of recovery
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The nerve block group was named the test group (T Group), and the laryngeal mask general anesthesia group was named the control group (C Group). The T Group received PECS II combined with intercostal nerve blockade, while the C Group underwent laryngeal mask insertion after general anesthesia induction.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative QoR-15 at 6 hours
timeFrame: 6 hours after the surgery
Secondary outcomes:
measure: Postoperative NRS pain score at 6 hours
timeFrame: 6 hours after the surgery
measure: The number of patients who experience intraoperative hypotension
timeFrame: From the beginning of anesthesia to the end of the surgery.
measure: Changes in hemodynamics (mean arterial pressure) after the surgical incision.
timeFrame: From the beginning of anesthesia to three minutes after the surgical incision.
measure: Changes in hemodynamics (heart rate) after the surgical incision.
timeFrame: From the beginning of anesthesia to three minutes after the surgical incision.
Other outcomes:
measure: Postoperative QoR-15 at 2 hours
timeFrame: 2 hours after the surgery
measure: Postoperative QoR-15 at 24 hours
timeFrame: 24 hours after the surgery
measure: Postoperative NRS pain score at 2 hours
timeFrame: 2 hours after the surgery
measure: Postoperative NRS pain score at 24 hours
timeFrame: 24 hours after the surgery
measure: The number of patients requiring additional analgesics
timeFrame: 24 hours after the surgery
measure: the number of patients who experience post-operative hypotension.
timeFrame: 24 hours after the surgery
measure: the number of patients who experience intraoperative Bradycardia.
timeFrame: From the beginning of anesthesia to the end of the surgery.
measure: the number of patients who experience post-operative Bradycardia.
timeFrame: 24 hours after the surgery
measure: Proportion of patients experiencing postoperative nausea and vomiting
timeFrame: 24 hours after the surgery
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: