Trial Outcomes & Findings for Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial (NCT NCT03201809)
NCT ID: NCT03201809
Last Updated: 2021-10-15
Results Overview
amount of narcotic used
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
post operation up to 2 days
Results posted on
2021-10-15
Participant Flow
Participant milestones
| Measure |
On-Q Catheter
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).
On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
|
Ultrasound Guided Pectoral Nerve Block
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
Ultrasound guided pectoral nerve block: 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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
On-Q Catheter
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).
On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
|
Ultrasound Guided Pectoral Nerve Block
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
Ultrasound guided pectoral nerve block: 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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
On-Q Catheter
n=6 Participants
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).
On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
|
Ultrasound Guided Pectoral Nerve Block
n=6 Participants
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
Ultrasound guided pectoral nerve block: 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
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.8 years
n=6 Participants
|
50.7 years
n=6 Participants
|
48.1 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: post operation up to 2 daysamount of narcotic used
Outcome measures
| Measure |
On-Q Catheter
n=6 Participants
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).
On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
|
Ultrasound Guided Pectoral Nerve Block
n=6 Participants
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
Ultrasound guided pectoral nerve block: 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
|
|---|---|---|
|
Post-operative Narcotic Usage
|
23.95 mg
Standard Deviation 24.32
|
6.43 mg
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: post operation up to 2 daysnumber and amount of anti-emetic used
Outcome measures
| Measure |
On-Q Catheter
n=6 Participants
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).
On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
|
Ultrasound Guided Pectoral Nerve Block
n=6 Participants
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
Ultrasound guided pectoral nerve block: 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
|
|---|---|---|
|
Post-operative Anti-emetic Usage
|
3.11 mg
Standard Deviation 3.33
|
2.00 mg
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: post operation up to 2 daysPain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale.
Outcome measures
| Measure |
On-Q Catheter
n=6 Participants
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).
On-Q: 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
|
Ultrasound Guided Pectoral Nerve Block
n=6 Participants
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
Ultrasound guided pectoral nerve block: 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
|
|---|---|---|
|
Post-operative Self-reported Pain Scores
Pain Level in Breasts Overall at Rest (Postop 7 days)
|
20.50 score on a scale
Standard Deviation 19.09
|
24.33 score on a scale
Standard Deviation 12.66
|
|
Post-operative Self-reported Pain Scores
Pain Level in Breasts Overall with Activity (Postop 7 days)
|
38.00 score on a scale
Standard Deviation 33.94
|
56.33 score on a scale
Standard Deviation 19.43
|
|
Post-operative Self-reported Pain Scores
Pain Level in Left Breast at Rest (Postop 7 days)
|
36.00 score on a scale
Standard Deviation 36.77
|
17.00 score on a scale
Standard Deviation 4.36
|
|
Post-operative Self-reported Pain Scores
Pain Level in Left Breast with Activity (Postop 7 days)
|
37.00 score on a scale
Standard Deviation 31.11
|
31.67 score on a scale
Standard Deviation 15.04
|
|
Post-operative Self-reported Pain Scores
Pain Level in Right Breast at Rest (Postop 7 days):
|
24.50 score on a scale
Standard Deviation 21.92
|
30.67 score on a scale
Standard Deviation 17.67
|
|
Post-operative Self-reported Pain Scores
Pain Level in Right Breast with Activity (Postop 7 days)
|
32.50 score on a scale
Standard Deviation 26.16
|
56.00 score on a scale
Standard Deviation 20.30
|
Adverse Events
On-Q Catheter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound Guided Pectoral Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Granger Wong, Chief and Professor of Plastic Surgery
UC Davis
Phone: (916) 734-7289
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place