Breast Cancer Clinical Trial
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.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 28, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Jun Zhang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Postoperative QoR-15 at 2 hours | The 15-item quality of recovery(QoR-15) at 2 hours after the surgery. | 2 hours after the surgery | |
Other | Postoperative QoR-15 at 24 hours | The 15-item quality of recovery(QoR-15) at 24 hours after the surgery. | 24 hours after the surgery | |
Other | 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. | 2 hours after the surgery | |
Other | 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. | 24 hours after the surgery | |
Other | The number of patients requiring additional analgesics | The number of patients requiring additional analgesics for rescue analgesia after the surgery is completed. | 24 hours after the surgery | |
Other | the number of patients who experience intraoperative hypotension. | A systolic blood pressure below 80mmHg is defined as hypotension. Record the number of patients who experience intraoperative hypotension. | 24 hours after the surgery | |
Other | 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. | From the beginning of anesthesia to the end of the surgery. | |
Other | the number of patients who experience intraoperative Bradycardia. | A heart rate below 45 bpm is defined as Bradycardia. Record the number of patients who experience Bradycardia. | 24 hours after the surgery | |
Other | Proportion of patients experiencing postoperative nausea and vomiting | Proportion of patients experiencing postoperative nausea and vomiting at least once at 24 hours postoperatively. | 24 hours after the surgery | |
Primary | 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 | 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. | 6 hours after the surgery | |
Secondary | the number of patients who experience intraoperative hypotension | During the surgery and anesthesia process, a systolic blood pressure below 80mmHg is defined as intraoperative hypotension. Record the number of patients who experience intraoperative hypotension. | From the beginning of anesthesia to the end of the surgery. | |
Secondary | 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. | From the beginning of anesthesia to three minutes after the surgical incision. | |
Secondary | 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. | From the beginning of anesthesia to three minutes after the surgical incision. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |