Post-operative Pain
Conditions
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.
Interventions
DEVICEOn-Q
0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
DRUGUltrasound 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
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two groups, conventional treatment versus experimental treatment; blocked randomization scheme
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Narcotic Usage | post operation up to 2 days | amount of narcotic used |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Anti-emetic Usage | post operation up to 2 days | number and amount of anti-emetic used |
| Post-operative Self-reported Pain Scores | post operation up to 2 days | Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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 | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | On-Q Catheter | Total | Ultrasound Guided Pectoral Nerve Block |
|---|---|---|---|
| Age, Continuous | 42.8 years | 48.1 years | 50.7 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Post-operative Narcotic Usage
amount of narcotic used
Time frame: post operation up to 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| On-Q Catheter | Post-operative Narcotic Usage | 23.95 mg | Standard Deviation 24.32 |
| Ultrasound Guided Pectoral Nerve Block | Post-operative Narcotic Usage | 6.43 mg | Standard Deviation 5.95 |
Secondary
Post-operative Anti-emetic Usage
number and amount of anti-emetic used
Time frame: post operation up to 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| On-Q Catheter | Post-operative Anti-emetic Usage | 3.11 mg | Standard Deviation 3.33 |
| Ultrasound Guided Pectoral Nerve Block | Post-operative Anti-emetic Usage | 2.00 mg | Standard Deviation 2.31 |
Secondary
Post-operative Self-reported Pain Scores
Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale.
Time frame: post operation up to 2 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| On-Q Catheter | 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 |
| On-Q Catheter | 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 |
| On-Q Catheter | 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 |
| On-Q Catheter | 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 |
| On-Q Catheter | 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 |
| On-Q Catheter | 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 |
| Ultrasound Guided Pectoral Nerve Block | Post-operative Self-reported Pain Scores | Pain Level in Right Breast at Rest (Postop 7 days): | 30.67 score on a scale | Standard Deviation 17.67 |
| Ultrasound Guided Pectoral Nerve Block | Post-operative Self-reported Pain Scores | Pain Level in Breasts Overall at Rest (Postop 7 days) | 24.33 score on a scale | Standard Deviation 12.66 |
| Ultrasound Guided Pectoral Nerve Block | Post-operative Self-reported Pain Scores | Pain Level in Left Breast with Activity (Postop 7 days) | 31.67 score on a scale | Standard Deviation 15.04 |
| Ultrasound Guided Pectoral Nerve Block | Post-operative Self-reported Pain Scores | Pain Level in Breasts Overall with Activity (Postop 7 days) | 56.33 score on a scale | Standard Deviation 19.43 |
| Ultrasound Guided Pectoral Nerve Block | Post-operative Self-reported Pain Scores | Pain Level in Right Breast with Activity (Postop 7 days) | 56.00 score on a scale | Standard Deviation 20.3 |
| Ultrasound Guided Pectoral Nerve Block | Post-operative Self-reported Pain Scores | Pain Level in Left Breast at Rest (Postop 7 days) | 17.00 score on a scale | Standard Deviation 4.36 |