Back to resultsModified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine 0.25% with epinephrine
Bupivacaine 0.25% with epinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists( ASA) I or II and scheduled for major breast cancer surgery( modified radical mastectomy or conservative mastectomy with axillary evacuation).
Exclusion Criteria:
- Local infection at the site of the block, coagulations abnormalities, allergy to local anesthetics or morphine, body mass index> 35, patient refusal, severe respiratory or cardiac disorders, pre-existing neurological deficits, hepatic or renal insufficiency, chronic pain syndrome, chronic analgesic use and psychiatric disorders.
Sites / Locations
- National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
modified pectoral nerves block
serratus plane block
Arm Description
Modified pectoral nerves block with general anesthesia. Using the ultrasound, 10 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis major and minor muscles. And another 20 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis minor and the serratus anterior muscles.
Serratus plane block with general anesthesia. Using the ultrasound, 0.4 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the serratus anterior muscle and the underlying ribs.
Outcomes
Primary Outcome Measures
Fentanyl consumption
Total morphine consumption
Visual analogue scale score at rest and during shoulder movement
Secondary Outcome Measures
Mean arterial blood pressure
Hemodynamics
Heart rate
Hemodynamics
Time to first requirement of rescue analgesia
Sedation score
as a side effect of morphine
Respiratory rate
respiratory depression defined as respiratory rate <12 breaths per minute
Nausea and vomiting
as a side effect of morphine
Patient satisfaction with postoperative analgesia
using numerical rating scale from 0 to 10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02946294
Brief Title
Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery
Official Title
A Comparative Study for Evaluation of the Analgesic Profile of Ultrasound-Guided Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
December 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the analgesic profile of modified pectoral nerves block and serratus plane block in patients undergoing mastectomy.
Detailed Description
This study includes three groups. The first group will receive ultrasound-guided modified pectoral nerves block prior to induction of general anesthesia. The second one will receive ultrasound-guided serratus plane block prior to induction of general anesthesia. The third one will not receive any block preoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
modified pectoral nerves block
Arm Type
Active Comparator
Arm Description
Modified pectoral nerves block with general anesthesia. Using the ultrasound, 10 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis major and minor muscles. And another 20 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis minor and the serratus anterior muscles.
Arm Title
serratus plane block
Arm Type
Active Comparator
Arm Description
Serratus plane block with general anesthesia. Using the ultrasound, 0.4 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the serratus anterior muscle and the underlying ribs.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% with epinephrine
Other Intervention Name(s)
Markyrene
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% with epinephrine
Other Intervention Name(s)
Markyrene
Primary Outcome Measure Information:
Title
Fentanyl consumption
Time Frame
Intraoperative
Title
Total morphine consumption
Time Frame
The first 24 hours postoperative
Title
Visual analogue scale score at rest and during shoulder movement
Time Frame
The first 24 hours postoperative
Secondary Outcome Measure Information:
Title
Mean arterial blood pressure
Description
Hemodynamics
Time Frame
Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative
Title
Heart rate
Description
Hemodynamics
Time Frame
Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative
Title
Time to first requirement of rescue analgesia
Time Frame
The first 24 hours postoperative
Title
Sedation score
Description
as a side effect of morphine
Time Frame
Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative
Title
Respiratory rate
Description
respiratory depression defined as respiratory rate <12 breaths per minute
Time Frame
Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative
Title
Nausea and vomiting
Description
as a side effect of morphine
Time Frame
The first 24 hours postoperative
Title
Patient satisfaction with postoperative analgesia
Description
using numerical rating scale from 0 to 10
Time Frame
One week after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists( ASA) I or II and scheduled for major breast cancer surgery( modified radical mastectomy or conservative mastectomy with axillary evacuation).
Exclusion Criteria:
Local infection at the site of the block, coagulations abnormalities, allergy to local anesthetics or morphine, body mass index> 35, patient refusal, severe respiratory or cardiac disorders, pre-existing neurological deficits, hepatic or renal insufficiency, chronic pain syndrome, chronic analgesic use and psychiatric disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman A Ghoneim, MD
Organizational Affiliation
National Cancer Institute, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmad H Aboul Soud, MD
Organizational Affiliation
National Cancer Institute, Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Khaled M Salem, Master
Organizational Affiliation
National Cancer Institute, Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed E Hassan, MD
Organizational Affiliation
National Cancer Institute, Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmad H Mohamed, MD
Organizational Affiliation
National Cancer Institute, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
State/Province
Misr Al Qadimah
ZIP/Postal Code
11796
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27687427
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
27413485
Citation
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Citation
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Citation
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Citation
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Citation
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Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery
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