Trial Outcomes & Findings for Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures (NCT NCT02604589)
NCT ID: NCT02604589
Last Updated: 2017-05-12
Results Overview
Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
3 days or hospital length of stay, if less than 3 days
Results posted on
2017-05-12
Participant Flow
Participant milestones
| Measure |
PCA Only
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
2
|
|
Overall Study
COMPLETED
|
3
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
PCA Only
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Overall Study
catheter dislodgement
|
0
|
0
|
1
|
Baseline Characteristics
Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures
Baseline characteristics by cohort
| Measure |
PCA Only
n=3 Participants
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
n=5 Participants
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
n=2 Participants
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
61.67 years
STANDARD_DEVIATION 16.56 • n=5 Participants
|
60.40 years
STANDARD_DEVIATION 24.93 • n=7 Participants
|
63.50 years
STANDARD_DEVIATION 6.36 • n=5 Participants
|
61.40 years
STANDARD_DEVIATION 18.52 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Number of Ribs Fractured
|
4.7 ribs
STANDARD_DEVIATION 2.5 • n=5 Participants
|
6.6 ribs
STANDARD_DEVIATION 3.7 • n=7 Participants
|
5.0 ribs
STANDARD_DEVIATION 1.4 • n=5 Participants
|
5.7 ribs
STANDARD_DEVIATION 2.9 • n=4 Participants
|
|
Admission Incentive Spirometry (IS) Volume
|
978 cc
STANDARD_DEVIATION 563 • n=5 Participants
|
783 cc
STANDARD_DEVIATION 630 • n=7 Participants
|
1567 cc
STANDARD_DEVIATION 818 • n=5 Participants
|
998 cc
STANDARD_DEVIATION 696 • n=4 Participants
|
|
Admission Pain Score
|
8 units on a scale
n=5 Participants
|
8 units on a scale
n=7 Participants
|
7 units on a scale
n=5 Participants
|
8 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 days or hospital length of stay, if less than 3 daysPopulation: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group
Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours.
Outcome measures
| Measure |
PCA Only
n=3 Participants
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
n=5 Participants
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
n=1 Participants
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Narcotic Use
|
3.7 mg/24 hours over days 1-3
Standard Deviation 3.5
|
8.2 mg/24 hours over days 1-3
Standard Deviation 5.16
|
2.5 mg/24 hours over days 1-3
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 3 days or hospital length of stay, if less than 3 daysPopulation: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one member to analyze; therefore standard deviation = 0.
Determine the impact of catheter-infused medications on maximal inspiratory lung volume measured by incentive spirometer (IS) as a change from baseline at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group). Endpoint will be the time to improvement of vital capacity to greater than 1.4 liters (or 15 mL/kg).
Outcome measures
| Measure |
PCA Only
n=3 Participants
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
n=5 Participants
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
n=1 Participants
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Time to Improvement in Pulmonary Function
|
1.7 days
Standard Deviation 1.5
|
1.8 days
Standard Deviation 1.6
|
1.0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 3 days or hospital length of stay, if less than 3 daysPopulation: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. Only one subject remains to be analyzed in that group so standard deviation = 0
Determine the impact of catheter-infused medications on self-reported pain intensity reported as a change from baseline (admission) at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group) on a 0-10 point Likert scale, with 0=no pain, and 10= the worst pain ever. Response will be defined as time to a decrease of at least two points on the scale.
Outcome measures
| Measure |
PCA Only
n=3 Participants
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
n=5 Participants
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
n=1 Participants
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Time to Improvement in Pain Intensity
|
2.0 days
Standard Deviation 0
|
3.0 days
Standard Deviation 0
|
1.0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 3 days or hospital length of stay, whichever is longerPopulation: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group
Collection of complications observed at any point during the hospital admission that included randomization, including pneumothorax, hemothorax, acute respiratory distress syndrome, pneumonia, empyema, need for tracheostomy, need for mechanical ventilation, length of time on mechanical ventilation, and an assessment of the degree of association of each event with the catheter insertion procedure or with underlying trauma. Each of these outcomes will be scored as yes/no.
Outcome measures
| Measure |
PCA Only
n=3 Participants
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
n=5 Participants
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
n=1 Participants
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Morbidity
|
0 number of complications
|
0 number of complications
|
0 number of complications
|
SECONDARY outcome
Timeframe: 30 daysPopulation: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group
All cause death, death associated with infusion catheter, within 30 days from date of randomization. This outcome will be scored as yes/no and cause of death will be collected.
Outcome measures
| Measure |
PCA Only
n=3 Participants
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
n=5 Participants
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
n=1 Participants
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from randomization to discharge, usually within the range of 5-15 daysPopulation: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one subject to analyze, so standard deviation =0
Integer days of inpatient admission in the hospital stay that included randomization.
Outcome measures
| Measure |
PCA Only
n=3 Participants
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
n=5 Participants
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
n=1 Participants
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Hospital Length of Stay
|
5.0 days
Standard Deviation 2.1
|
11.1 days
Standard Deviation 8.6
|
3.6 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care UnitPopulation: Only patients analyzed who had surgical intensive care unit admission.
Integer days of admission to the surgical intensive care unit. For patients not requiring admission to surgical intensive care, patient is not analyzed. Usual range is 3-5 days.
Outcome measures
| Measure |
PCA Only
n=1 Participants
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
n=3 Participants
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Surgical Intensive Care Unit (SICU) Length of Stay
|
2.3 days
Standard Deviation 0
|
5.1 days
Standard Deviation 3.4
|
—
|
Adverse Events
PCA Only
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Bupivicaine 0.25% (LOW DOSE)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Bupivicaine 0.5% (HIGH DOSE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PCA Only
n=3 participants at risk
Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
|
Bupivicaine 0.25% (LOW DOSE)
n=5 participants at risk
bupivicaine 0.25%: Low Dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter.
|
Bupivicaine 0.5% (HIGH DOSE)
n=1 participants at risk
bupivicaine 0.5%: High dose analgesia
Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter.
|
|---|---|---|---|
|
Renal and urinary disorders
Low urine output
|
0.00%
0/3 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
0.00%
0/1 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
0.00%
0/1 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
|
Renal and urinary disorders
Urinary Retention
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
0.00%
0/5 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
0.00%
0/1 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
0.00%
0/1 • Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place