The Effects of Perioperative PECS Block During Robotic Breast Surgery and Breast Reconstruction
NCT ID: NCT04440995
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-07-08
2021-10-10
Brief Summary
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Detailed Description
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A Patient -controlled analgesia(PCA) device provides fentanyl for postoperative pain control.
The Primary outcome measures total dose of fentanyl consumption during the postoperative 24 hours, and secondary outcome measures pain scores at rest and movement.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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PECS block(P) group
PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.
pectoral nerve block
Patients received standardized general anesthesia. PECS block were applied under vision using blunted tip cannula(27G, 30mm) after surgical resection of breast by operator. 0.25% ropivacaine 10ml was injected into fascia between pectoralis major and minor muscles. 0.25% ropivacaine 20ml was injected into fascia between pectoralis minor and serratus anterior muscles at the level of the third rib. Breast reconstruction is performed after PECS block
Control(c) group
only received general anesthesia
No interventions assigned to this group
Interventions
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pectoral nerve block
Patients received standardized general anesthesia. PECS block were applied under vision using blunted tip cannula(27G, 30mm) after surgical resection of breast by operator. 0.25% ropivacaine 10ml was injected into fascia between pectoralis major and minor muscles. 0.25% ropivacaine 20ml was injected into fascia between pectoralis minor and serratus anterior muscles at the level of the third rib. Breast reconstruction is performed after PECS block
Eligibility Criteria
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Inclusion Criteria
2. Scheduled for robot-assisted nipple-sparing mastectomy with immediate gel implant or tissue expander breast reconstruction
3. American Society of Anesthesiologists(ASA) physical status I and III
Exclusion Criteria
2. Reoperation
3. Patients with local anesthetic allergy
4. Patients with coagulopathy
5. Patients on anticoagulants
6. Patients who cannot use patient controlled analgesia(PCA)
7. Patients with morbid obesity \[body mass index (BMI) \>35 kg/m2\]
8. Patients with history of uncontrolled hypertension (diastolic BP \>110mmHg) or DM
9. Patients with history of heart failure (unstable angina, congestive heart failure)
10. Patients with history of liver failure, renal failure, allergic to medicine
11. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
12. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
13. Patients who cannot read the consent form (examples: Illiterate, foreigner)
14. Patients who withdraw the consent
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Sun Jun Bai, Ph.D
Role: STUDY_DIRECTOR
Severance Hospital
Locations
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Yonsei Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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4-2020-0430
Identifier Type: -
Identifier Source: org_study_id