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Completed

NCT Number: NCT06120439

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast-conserving Surgery Neoplasms Neoplasms by Site Pectoral Nerves Block Sentinel Lymph Node Biopsy Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative QoR-15 at 6 hours

    Time frame: 6 hours after the surgery

    The 15-item quality of recovery(QoR-15) at 6 hours after the surgery.

Secondary outcomes

  1. Postoperative NRS pain score at 6 hours

    Time frame: 6 hours after the surgery

    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.

  2. The number of patients who experience intraoperative hypotension

    Time frame: From the beginning of anesthesia to the end of the surgery.

    During the surgery and anesthesia process, MAP ≤ 65 mmHg is defined as intraoperative hypotension. Record the number of patients who experience intraoperative hypotension.

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

    Time frame: From the beginning of anesthesia to three minutes 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.

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

    Time frame: From the beginning of anesthesia to three minutes 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.

Other outcomes

  1. Postoperative QoR-15 at 2 hours

    Time frame: 2 hours after the surgery

    The 15-item quality of recovery(QoR-15) at 2 hours after the surgery.

  2. Postoperative QoR-15 at 24 hours

    Time frame: 24 hours after the surgery

    The 15-item quality of recovery(QoR-15) at 24 hours after the surgery.

  3. Postoperative NRS pain score at 2 hours

    Time frame: 2 hours after the surgery

    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.

  4. Postoperative NRS pain score at 24 hours

    Time frame: 24 hours after the surgery

    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.

  5. The number of patients requiring additional analgesics

    Time frame: 24 hours after the surgery

    The number of patients requiring additional analgesics for rescue analgesia after the surgery is completed.

  6. the number of patients who experience post-operative hypotension.

    Time frame: 24 hours after the surgery

    MAP ≤ 65 mmHg is defined as hypotension. Record the number of patients who experience intraoperative hypotension.

  7. the number of patients who experience intraoperative Bradycardia.

    Time frame: From the beginning of anesthesia to the end of the surgery.

    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.

  8. the number of patients who experience post-operative Bradycardia.

    Time frame: 24 hours after the surgery

    A heart rate below 45 bpm is defined as Bradycardia. Record the number of patients who experience Bradycardia.

  9. Proportion of patients experiencing postoperative nausea and vomiting

    Time frame: 24 hours after the surgery

    Proportion of patients experiencing postoperative nausea and vomiting at least once at 24 hours postoperatively.

Sponsors and collaborators

Lead sponsor

Jun Zhang

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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