Back to resultsTPVB, PECSB, ESPB for Postmastectmy Pain (RCT)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound guided block
IV morphine
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- ASA physical status classification class I or II
- Age group 18 - 60 years of the female gender
- Patients undergoing breast cancer surgeries
Exclusion Criteria:
- Patient refusal
- History of hypersensitivity to local anesthetics
- Bleeding disorders or patients receiving anticoagulants
- Spine or chest wall deformities
- Pregnancy
- Local infection at the site of injection.
Sites / Locations
- Faculty of Medicine Menofia University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control Group (D)
Paravertebral block Group (A)
Pectoral block Group (B)
Erector spinae block Group (C)
Arm Description
Patient will receive opioid only for management of their perioperative pain
Will receive thoracic paravertebral block
Will receive pectoral 1 and 2 block
Will receive erector spinae block
Outcomes
Primary Outcome Measures
The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).
minutes
Secondary Outcome Measures
Postoperative pain
assessed by VAS score (0-10) where 0=no pain and 10=worst pain
Total morphine consumption
recorded postoperatively in mg
Postoperative nausea and vomiting (PONV)
4 points score of PONV (0-3) where 0=no PONV and 3=vomiting more than once
Full Information
NCT ID
NCT05076773
First Posted
September 14, 2021
Last Updated
September 29, 2021
Sponsor
Menoufia University
1. Study Identification
Unique Protocol Identification Number
NCT05076773
Brief Title
TPVB, PECSB, ESPB for Postmastectmy Pain
Acronym
RCT
Official Title
A Comparative Study Between Ultrasound-guided Thoracic Paravertebral Block, Pectoral Nerves Block, and Erector Spinae Block for Pain Management in Cancer Breast Surgeries. A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group (D)
Arm Type
Placebo Comparator
Arm Description
Patient will receive opioid only for management of their perioperative pain
Arm Title
Paravertebral block Group (A)
Arm Type
Active Comparator
Arm Description
Will receive thoracic paravertebral block
Arm Title
Pectoral block Group (B)
Arm Type
Active Comparator
Arm Description
Will receive pectoral 1 and 2 block
Arm Title
Erector spinae block Group (C)
Arm Type
Active Comparator
Arm Description
Will receive erector spinae block
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided block
Other Intervention Name(s)
Us guided paravertebral block, Us guided erector spinae block, Us guided PECs 1 and 2
Intervention Description
Giving one regional block
Intervention Type
Drug
Intervention Name(s)
IV morphine
Intervention Description
given when VAS>3
Primary Outcome Measure Information:
Title
The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).
Description
minutes
Time Frame
0-24o minutess
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
assessed by VAS score (0-10) where 0=no pain and 10=worst pain
Time Frame
48 hours
Title
Total morphine consumption
Description
recorded postoperatively in mg
Time Frame
48 hours
Title
Postoperative nausea and vomiting (PONV)
Description
4 points score of PONV (0-3) where 0=no PONV and 3=vomiting more than once
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA physical status classification class I or II
Age group 18 - 60 years of the female gender
Patients undergoing breast cancer surgeries
Exclusion Criteria:
Patient refusal
History of hypersensitivity to local anesthetics
Bleeding disorders or patients receiving anticoagulants
Spine or chest wall deformities
Pregnancy
Local infection at the site of injection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kareem M mikhimer, m.sc
Organizational Affiliation
assistant fellow, Ahmed Maher Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Menofia University
City
Shibīn Al Kawm
State/Province
Menofia
ZIP/Postal Code
32511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Title only
Learn more about this trial
TPVB, PECSB, ESPB for Postmastectmy Pain
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