Back to resultsErector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy
Primary Purpose
Breast Surgery, Thoracic Paravertebral Block, Post-operative Pain Control
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Thoracic paravertebral block
Erector spinae plane Block
Sponsored by
About this trial
This is an interventional treatment trial for Breast Surgery focused on measuring breast surgery, Thoracic paravertebral block, Erector spinae plane block, Mastectomy, post-operative pain control
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 18 and 85
- American Society of Anesthesiologists classification I - III
- Signature of consent to participate in the study
Exclusion Criteria:
- Coagulopathies and / or use of antiplatelet / anticoagulant drugs
- Infections and/or lesions at the puncture site,
- BMI ≥40
- allergies and / or contraindications to the administration of the drugs used in the study,
- use of chronic opioid therapy
Sites / Locations
- Domenico Pietro Santonastaso
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TPV Block
ESP Block
Arm Description
Thoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level.
Erector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level.
Outcomes
Primary Outcome Measures
Post-operative pain assessment
post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)
Secondary Outcome Measures
Length of hospital stay
The number of days of hospitalization after surgery will be assessed
Evaluate the incidence and severity of persistent pain 6 months after surgery
Evaluate the incidence and severity of persistent pain 6 months after surgery using Numeric rating scale (from 0, no pain, to 10, worst pain)
Opioid use
Intra and post-operative opioid use
Incidence of PONV
Incidence of post operative nausea and vomiting (PONV) in the first 36 hours
Assessment of patient satisfaction with the anesthesiological technique
Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates "entirely dissatisfied" and 5 indi- cates "very satisfied"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04457115
Brief Title
Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy
Official Title
Comparison of Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Intra and Postoperative Pain Control in Modified Radical Mastectomy: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AUSL Romagna Rimini
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block versus thoracic paravertebral (TPV) block in the post-operative pain control after radical mastectomy.
Detailed Description
Primary outcome of our study is to compare the effectiveness of two regional anesthesia techniques, ESP block and TPV block, in the post-operative pain-control after radical mastectomy.
We will also evaluate both intra and post-operative opioid consumption, the incidence of PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and the incidence of chronic pain 6 months after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Surgery, Thoracic Paravertebral Block, Post-operative Pain Control, Erector Spinae Plane Block, Opioid Use
Keywords
breast surgery, Thoracic paravertebral block, Erector spinae plane block, Mastectomy, post-operative pain control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TPV Block
Arm Type
Experimental
Arm Description
Thoracic paravertebral block performed at thoracic level T2-T3 and T4-T5 with administration of Ropivacaine 0.7% 8 ml for each level.
Arm Title
ESP Block
Arm Type
Experimental
Arm Description
Erector spinae plane block performed at thoracic level T2 and T5 with administration of Ropivacaine 0.5% 12 ml for each level.
Intervention Type
Procedure
Intervention Name(s)
Thoracic paravertebral block
Intervention Description
Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane Block
Intervention Description
Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level
Primary Outcome Measure Information:
Title
Post-operative pain assessment
Description
post-operative pain assessment using Numeric rating scale (from 0,no pain, to 10 ,worst pain)
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
The number of days of hospitalization after surgery will be assessed
Time Frame
3 days
Title
Evaluate the incidence and severity of persistent pain 6 months after surgery
Description
Evaluate the incidence and severity of persistent pain 6 months after surgery using Numeric rating scale (from 0, no pain, to 10, worst pain)
Time Frame
six months
Title
Opioid use
Description
Intra and post-operative opioid use
Time Frame
36 hours
Title
Incidence of PONV
Description
Incidence of post operative nausea and vomiting (PONV) in the first 36 hours
Time Frame
36 hours
Title
Assessment of patient satisfaction with the anesthesiological technique
Description
Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates "entirely dissatisfied" and 5 indi- cates "very satisfied"
Time Frame
36 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged between 18 and 85
American Society of Anesthesiologists classification I - III
Signature of consent to participate in the study
Exclusion Criteria:
Coagulopathies and / or use of antiplatelet / anticoagulant drugs
Infections and/or lesions at the puncture site,
BMI ≥40
allergies and / or contraindications to the administration of the drugs used in the study,
use of chronic opioid therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domenico P Santonastaso, MD
Organizational Affiliation
AUSL Romagna, M. Bufalini Hospital, Cesena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Domenico Pietro Santonastaso
City
Cesena
State/Province
Emilia Romagna
ZIP/Postal Code
47521
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy
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