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Poor enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On-Q Catheter | Experimental | 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). |
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| Ultrasound Guided Pectoral Nerve Block | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| On-Q | Device | 0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Narcotic Usage | amount of narcotic used | post operation up to 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Anti-emetic Usage | number and amount of anti-emetic used | post operation up to 2 days |
| Post-operative Self-reported Pain Scores | Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Wong, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
available only as aggregate / HIPAA non-identifiable data in published papers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Ultrasound Guided Pectoral Nerve Block |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2018 |
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Two groups, conventional treatment versus experimental treatment; blocked randomization scheme
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| Ultrasound guided pectoral nerve block |
| Drug |
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 operation up to 2 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 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Narcotic Usage | amount of narcotic used | Posted | Mean | Standard Deviation | mg | post operation up to 2 days |
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| Secondary | Post-operative Anti-emetic Usage | number and amount of anti-emetic used | Posted | Mean | Standard Deviation | mg | post operation up to 2 days |
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| ||||||||||||||||||||||||||||||
| Secondary | Post-operative Self-reported Pain Scores | Pain scores overall and by breast: 0 (no pain) - 100 (extreme pain) analog scale. | Posted | Mean | Standard Deviation | score on a scale | post operation up to 2 days |
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Up to 10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
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Due to 2 patients being lost to follow up and the small total number of subjects, the study findings were limited. Because of the nominal number of breast reconstruction patients at our institution meeting inclusion criteria for this trial, there was low enrollment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Granger Wong, Chief and Professor of Plastic Surgery | UC Davis | (916) 734-7289 | gwong@ucdavis.edu |
| Jul 8, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2018 | Jul 8, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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