Back to resultsComparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
Primary Purpose
Post-operative Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
On-Q
Ultrasound guided pectoral nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain
Eligibility Criteria
Inclusion Criteria:
- presenting for breast reconstruction w/ planned two-stage, sub muscular tissue expander placement.
Exclusion Criteria:
- pregnant, prisoners, cannot consent, history of chronic pain or pain medication use
Sites / Locations
- UC Davis Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
On-Q Catheter
Ultrasound Guided Pectoral Nerve Block
Arm Description
On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days).
Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection
Outcomes
Primary Outcome Measures
Post-operative Narcotic Usage
amount of narcotic used
Secondary Outcome Measures
Post-operative Anti-emetic Usage
number and amount of anti-emetic used
Post-operative Self-reported Pain Scores
Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale.
Full Information
NCT ID
NCT03201809
First Posted
June 21, 2017
Last Updated
October 14, 2021
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03201809
Brief Title
Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
Official Title
Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates the use of post-operative on-Q pain catheters for tissue expander based breast reconstruction, versus conventional ultrasound-guided blocks placed pre-operatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups, conventional treatment versus experimental treatment; blocked randomization scheme
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
On-Q Catheter
Arm Type
Experimental
Arm Description
On-Q catheters placed within the implant pocket; infusion of 0.2% Ropivacaine at 4 mL/h for a total of 400 mL (about 4 days).
Arm Title
Ultrasound Guided Pectoral Nerve Block
Arm Type
Active Comparator
Arm Description
Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the pecs 2 injection
Intervention Type
Device
Intervention Name(s)
On-Q
Intervention Description
0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
Intervention Type
Drug
Intervention Name(s)
Ultrasound guided pectoral nerve block
Intervention Description
Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection
Primary Outcome Measure Information:
Title
Post-operative Narcotic Usage
Description
amount of narcotic used
Time Frame
post operation up to 2 days
Secondary Outcome Measure Information:
Title
Post-operative Anti-emetic Usage
Description
number and amount of anti-emetic used
Time Frame
post operation up to 2 days
Title
Post-operative Self-reported Pain Scores
Description
Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale.
Time Frame
post operation up to 2 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
presenting for breast reconstruction w/ planned two-stage, sub muscular tissue expander placement.
Exclusion Criteria:
pregnant, prisoners, cannot consent, history of chronic pain or pain medication use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Wong, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
available only as aggregate / HIPAA non-identifiable data in published papers.
Learn more about this trial
Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial
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