Breast CancerNCT06120439
Comparing the QoR of PECS Block and GA in Breast-conserving Surgery With Sentinel Lymph Node Biopsy
A study testing PECS II combined with intercostal nerve blockade; and General anesthesia with laryngeal mask in people with Breast Cancer and Pectoral Nerves Block, run by Jun Zhang at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Pectoral Nerves Block, Breast-Conserving Surgery
- What is being tested?
- PECS II combined with intercostal nerve blockade; and General anesthesia with laryngeal mask
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Pectoral Nerves Block, Breast-Conserving Surgery, Sentinel Lymph Node Biopsy
- Being tested
- PECS II combined with intercostal nerve blockade;, General anesthesia with laryngeal mask
- Keywords
- Pectoral nerves block II, intercostal nerve block, dexmedetomidine, breast-conserving surgery, sentinel lymph node biopsy, quality of recovery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 maskCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| T Group | Experimental | The T Group received PECS II(PMID: 22939099) combined with intercostal nerve block Receives: Combination Product: PECS II combined with intercostal nerve blockade; |
| C Group | Active comparator | C Group underwent laryngeal mask insertion after general anesthesia induction. Receives: Combination Product: General anesthesia with laryngeal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative QoR-15 at 6 hours
The 15-item quality of recovery(QoR-15) at 6 hours after the surgery.
Measured: 6 hours after the surgery
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the beginning of anesthesia to three minutes after the surgical incision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Dec 2023
- Primary completion11 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120439
- Sponsor's protocol ID
- CSYDXSJLHLJSJ-1
- Status last verified
- Nov 2025
- First submitted
- 1 Nov 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06120439
- Acronym / sponsor ID
- CSYDXSJLHLJSJ-1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| T Group | Experimental | Combination Product: PECS II combined with intercostal nerve blockade;The T Group received PECS II(PMID: 22939099) combined with intercostal nerve block |
| C Group | Active comparator | Combination Product: General anesthesia with laryngeal maskC Group underwent laryngeal mask insertion after general anesthesia induction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | T Group |
| General anesthesia with laryngeal maskThe 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. | Combination product | C Group |
Primary outcome
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.
4 secondary outcomes
Postoperative NRS pain score at 6 hours
Time frame: 6 hours after the surgery
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.
Time frame: From the beginning of anesthesia to three minutes after the surgical incision.
Changes in hemodynamics (heart rate) after the surgical incision.
Time frame: From the beginning of anesthesia to three minutes after the surgical incision.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECS II combined with intercostal nerve blockade; and General anesthesia with laryngeal mask in people with Breast Cancer and Pectoral Nerves Block, run by Jun Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative QoR-15 at 6 hours (time frame: 6 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.