An interventional study of PECS II combined with intercostal nerve blockade; and General anesthesia with laryngeal mask in Breast Cancer, Pectoral Nerves Block and Breast-Conserving Surgery, sponsored by Jun Zhang. Completed at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Jun Zhang · Not applicable, Interventional, and Treatment
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 96 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Jun Zhang is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The T Group received PECS II(PMID: 22939099) combined with intercostal nerve block
Combination Product: PECS II combined with intercostal nerve blockade;
C Group underwent laryngeal mask insertion after general anesthesia induction.
Combination Product: General anesthesia with laryngeal mask
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.
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.
Postoperative QoR-15 at 6 hours
The 15-item quality of recovery(QoR-15) at 6 hours after the surgery.
Time frame: 6 hours after the surgery
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.
Time frame: 6 hours after the surgery
The number of patients who experience intraoperative hypotension
During the surgery and anesthesia process, MAP ≤ 65 mmHg is defined as intraoperative hypotension. Record the number of patients who experience intraoperative hypotension.
Time frame: From the beginning of anesthesia to the end of the surgery.
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.
Time frame: From the beginning of anesthesia to three minutes after the surgical incision.
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.
Time frame: From the beginning of anesthesia to three minutes after the surgical incision.
Postoperative QoR-15 at 2 hours
The 15-item quality of recovery(QoR-15) at 2 hours after the surgery.
Time frame: 2 hours after the surgery
Postoperative QoR-15 at 24 hours
The 15-item quality of recovery(QoR-15) at 24 hours after the surgery.
Time frame: 24 hours after the surgery
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.
Time frame: 2 hours after the surgery
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.
Time frame: 24 hours after the surgery
The number of patients requiring additional analgesics
The number of patients requiring additional analgesics for rescue analgesia after the surgery is completed.
Time frame: 24 hours after the surgery
the number of patients who experience post-operative hypotension.
MAP ≤ 65 mmHg is defined as hypotension. Record the number of patients who experience intraoperative hypotension.
Time frame: 24 hours after the surgery
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.
Time frame: From the beginning of anesthesia to the end of the surgery.
the number of patients who experience post-operative Bradycardia.
A heart rate below 45 bpm is defined as Bradycardia. Record the number of patients who experience Bradycardia.
Time frame: 24 hours after the surgery
Proportion of patients experiencing postoperative nausea and vomiting
Proportion of patients experiencing postoperative nausea and vomiting at least once at 24 hours postoperatively.
Time frame: 24 hours after the surgery
Plan to share: No
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Jun Zhang