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The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduces the opioid consumption during the surgery and postoperative pain after breast cancer surgery.
Forty adult female participants scheduled for elective breast cancer surgery under general anesthesia are randomly allocated to receive either general anesthesia plus Pecs block(Pecs group, n=20) or general anesthesia alone (control group, n=20).
After arrived in the operating room，all patients undergo operation under total intravenous anesthesia (TIVA) with or without pectoral nerves blocks(PECS) . After anesthesia induction，the participants in the Pecs group receive an ultrasound-guided Pecs block before the start of the operation.
Pecs block technology：After cleaning the infraclavicular and axillary regions , the linear probe is placed below the lateral third of the clavicle. After recognition of the appropriate anatomical structures, then the block is performed . The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .
During operation the remifentanil administration in each group is guided using the surgical pleth index( SPI). the SPI target range was 20 to 50 Anesthetic depth is maintained and continuously adjusted with propofol to achieve Bispectral Index (BIS) between 40 and 60.
primary outcome intraoperative remifentanil consumption secondaty outcome postoperative pain score and rescue analgesic requirement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pecs group | Experimental | Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle . |
|
| control group | No Intervention | There is no block. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pecs II block | Procedure | After identifying the axillary vein and artery, the ultrasound probe was positioned inferio-laterally, between the 3rd and 4th ribs, and then the pectoralis major and minor, and serratus anterior muscles were confirmed. The needle was advanced in a medio-lateral direction in-plane view of the ultrasound. For the Pecs II block, a total 30 mL of 0.5% ropivacaine was injected. First, the needle tip was advanced into the fascia between the pectoralis major and minor muscles and 10 mL of 0.5% ropivacaine was injected. Thereafter, the needle tip was advanced into the tissue plane between the pectoralis minor and serratus anterior muscles, and 20 mL of 0.5% ropivacaine was injected in a similar manner. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Remifentanil Consumption | Intraoperative remifentanil consumption during surgery(whole intraoperative period) | whole intraoperative period |
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Inclusion Criteria:
American Society of Anesthesiologists( ASA) I or II Scheduled for breast cancer surgery
Exclusion Criteria:
Sensitivity to local anesthetic, Bleeding disorders , Receiving anticoagulant, Body mass index (BMI) > 35/kg/m2 , Spine or chest wall deformity , Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Kyung Cheon Lee | Gachon University Gil Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Cheon Lee | Incheon | 22241 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pecs Group | Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle . |
| FG001 | Control Group | There is no block. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pecs Group | Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative Remifentanil Consumption | Intraoperative remifentanil consumption during surgery(whole intraoperative period) | Posted | Mean | Standard Deviation | μg/kg/h | whole intraoperative period |
|
3days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pecs Group | Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle . |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Junju Choi | Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University | 82-32-460-3636 | jjchoi2@gilhospital.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2019 | Oct 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Patients either received the Pecs II block (Pecs group) or did not receive it (control group).
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One anesthesiologist (JJC) performed all blocks in the Pecs group enrolled patients. After the intervention, the participants and the investigator responsible for the study outcome assessment were blinded.
|
| BG001 | Control Group | There is no block. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| weight | Mean | Standard Deviation | kg |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Control Group | There is no block. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D017437 |
| Skin and Connective Tissue Diseases |