Back to resultsThe Effects of Perioperative PECS Block During Robotic Breast Surgery and Breast Reconstruction
Primary Purpose
Breast Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pectoral nerve block
Sponsored by
About this trial
This is an interventional prevention trial for Breast Neoplasm focused on measuring breast neoplasms
Eligibility Criteria
Inclusion Criteria:
- 20years or older
- Scheduled for robot-assisted nipple-sparing mastectomy with immediate gel implant or tissue expander breast reconstruction
- American Society of Anesthesiologists(ASA) physical status I and III
Exclusion Criteria:
- Emergency operation
- Reoperation
- Patients with local anesthetic allergy
- Patients with coagulopathy
- Patients on anticoagulants
- Patients who cannot use patient controlled analgesia(PCA)
- Patients with morbid obesity [body mass index (BMI) >35 kg/m2]
- Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM
- Patients with history of heart failure (unstable angina, congestive heart failure)
- Patients with history of liver failure, renal failure, allergic to medicine
- Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
- Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
- Patients who cannot read the consent form (examples: Illiterate, foreigner)
- Patients who withdraw the consent
Sites / Locations
- Yonsei Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PECS block(P) group
Control(c) group
Arm Description
PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.
only received general anesthesia
Outcomes
Primary Outcome Measures
Total dose of fentanyl consumption during the postoperative 24h
To evaluate the effect of PECS block undergoing robot-assisted nipple-sparing mastectomy (RANSM) with immediate breast reconstruction (IBR), total cumulative dose of fentanyl was measured for the first postoperative 24h
Secondary Outcome Measures
a numeric rating score at rest
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at rest
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at rest
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at rest
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at rest
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at rest
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at rest
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at rest
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at rest
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
a numeric rating score at movement
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04440995
Brief Title
The Effects of Perioperative PECS Block During Robotic Breast Surgery and Breast Reconstruction
Official Title
The Effects of Perioperative PECS Block on Postoperative Pain Control During Robotic Breast Surgery and Breast Reconstruction - Double Blind Randomized Controlled Trial -
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
October 10, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pectoral nerve blocks (PECS blok) are used in postoperative analgesia after breast surgery in nowadays. Many studies shows that pectoral nerve blocks is effective for reducing pain and postoperative opioid consumption undergoing mastectomy. This study was planned to evaluate the efficacy of intraoperative PECS block for postoperative analgesia after robot breast surgery and immediate breast reconstruction.
Detailed Description
Sixty patients were randomly allocated into two groups by computerised process, each including 30 patients. PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator. Control group(C) only received general anesthesia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
Keywords
breast neoplasms
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PECS block(P) group
Arm Type
Experimental
Arm Description
PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.
Arm Title
Control(c) group
Arm Type
No Intervention
Arm Description
only received general anesthesia
Intervention Type
Procedure
Intervention Name(s)
pectoral nerve block
Intervention Description
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
Primary Outcome Measure Information:
Title
Total dose of fentanyl consumption during the postoperative 24h
Description
To evaluate the effect of PECS block undergoing robot-assisted nipple-sparing mastectomy (RANSM) with immediate breast reconstruction (IBR), total cumulative dose of fentanyl was measured for the first postoperative 24h
Time Frame
after 24 hours postoperative period
Secondary Outcome Measure Information:
Title
a numeric rating score at rest
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
0 hour after surgery
Title
a numeric rating score at rest
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
0.5 hour after surgery
Title
a numeric rating score at rest
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
1 hour after surgery
Title
a numeric rating score at rest
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
2 hours after surgery
Title
a numeric rating score at rest
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
4 hours after surgery
Title
a numeric rating score at rest
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
6 hours after surgery
Title
a numeric rating score at rest
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
8 hours after surgery
Title
a numeric rating score at rest
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
12 hours after surgery
Title
a numeric rating score at rest
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
24 hours after surgery
Title
a numeric rating score at movement
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
0 hour after surgery
Title
a numeric rating score at movement
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
0.5 hour after surgery
Title
a numeric rating score at movement
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
1 hour after surgery
Title
a numeric rating score at movement
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
2 hours after surgery
Title
a numeric rating score at movement
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
4 hours after surgery
Title
a numeric rating score at movement
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
6 hours after surgery
Title
a numeric rating score at movement
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
8 hours after surgery
Title
a numeric rating score at movement
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
12 hours after surgery
Title
a numeric rating score at movement
Description
Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20years or older
Scheduled for robot-assisted nipple-sparing mastectomy with immediate gel implant or tissue expander breast reconstruction
American Society of Anesthesiologists(ASA) physical status I and III
Exclusion Criteria:
Emergency operation
Reoperation
Patients with local anesthetic allergy
Patients with coagulopathy
Patients on anticoagulants
Patients who cannot use patient controlled analgesia(PCA)
Patients with morbid obesity [body mass index (BMI) >35 kg/m2]
Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM
Patients with history of heart failure (unstable angina, congestive heart failure)
Patients with history of liver failure, renal failure, allergic to medicine
Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
Patients who cannot read the consent form (examples: Illiterate, foreigner)
Patients who withdraw the consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Jun Bai, Ph.D
Organizational Affiliation
Severance Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Yonsei Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Perioperative PECS Block During Robotic Breast Surgery and Breast Reconstruction
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