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

NCT06120439 | Completed

• 1 other identifier: CSYDXSJLHLJSJ-1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative NRS pain score at 6 hours

  6 hours after the surgery

• The number of patients who experience intraoperative hypotension

  From the beginning of anesthesia to the end of the surgery.

• Changes in hemodynamics (mean arterial pressure) after the surgical incision.

  From the beginning of anesthesia to three minutes after the surgical incision.

• Changes in hemodynamics (heart rate) after the surgical incision.

  From the beginning of anesthesia to three minutes after the surgical incision.

Other Outcomes (9)

• Postoperative QoR-15 at 2 hours

  2 hours after the surgery

• Postoperative QoR-15 at 24 hours

  24 hours after the surgery

• Postoperative NRS pain score at 2 hours

  2 hours after the surgery

Study Arms (2)

T Group

EXPERIMENTAL

The T Group received PECS II(PMID: 22939099) combined with intercostal nerve block

Combination Product: PECS II combined with intercostal nerve blockade;

C Group

ACTIVE COMPARATOR

C Group underwent laryngeal mask insertion after general anesthesia induction.

Combination Product: General anesthesia with laryngeal mask

Interventions

PECS II combined with intercostal nerve blockade; COMBINATION_PRODUCT

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.

T Group

General anesthesia with laryngeal mask COMBINATION_PRODUCT

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.

C Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jun Zhang: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anesthesia, General; Laryngeal Masks

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The follow-up personnel and data analysts are blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department of Anesthesiology, Fudan University Shanghai Cancer Center

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion: May 11, 2024
• Study Completion: May 15, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)