Trial · NCT02604589
Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures
NCT02604589, Not applicable, Terminated, Anthony Iacco; results first posted 2017-05-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures. Trials, record NCT02604589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02604589
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures
- NCT number
- NCT02604589
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 10 participants, actual
- Lead sponsor
- Anthony Iacco
- Conditions
- Rib Fractures
- Interventions
- hydromorphone hydrochloride, Infusion catheter placement, bupivicaine 0.25%, bupivicaine 0.5%
- First posted
- 2015-11-13
- Last updated
- 2017-05-12
- Results first posted
- 2017-05-12
- Limitations and caveats
- Study terminated early due to lack of enrollment.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Narcotic Use | 3 days or hospital length of stay, if less than 3 days | Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours. |
| Secondary | Time to Improvement in Pulmonary Function | 3 days or hospital length of stay, if less than 3 days | 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). |
| Secondary | Time to Improvement in Pain Intensity | 3 days or hospital length of stay, if less than 3 days | 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. |
| Secondary | Morbidity | 3 days or hospital length of stay, whichever is longer | 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. |
| Secondary | Mortality | 30 days | 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. |
| Secondary | Hospital Length of Stay | from randomization to discharge, usually within the range of 5-15 days | Integer days of inpatient admission in the hospital stay that included randomization. |
| Secondary | Surgical Intensive Care Unit (SICU) Length of Stay | from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Narcotic Use | 3 days or hospital length of stay, if less than 3 days | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group | mg/24 hours over days 1-3 | MEAN |
| SECONDARY | Time to Improvement in Pulmonary Function | 3 days or hospital length of stay, if less than 3 days | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one member to analyze; therefore standard deviation = 0. | days | MEAN |
| SECONDARY | Time to Improvement in Pain Intensity | 3 days or hospital length of stay, if less than 3 days | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. Only one subject remains to be analyzed in that group so standard deviation = 0 | days | MEAN |
| SECONDARY | Morbidity | 3 days or hospital length of stay, whichever is longer | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group | number of complications | NUMBER |
| SECONDARY | Mortality | 30 days | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hospital Length of Stay | from randomization to discharge, usually within the range of 5-15 days | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one subject to analyze, so standard deviation =0 | days | MEAN |
| SECONDARY | Surgical Intensive Care Unit (SICU) Length of Stay | from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit | Only patients analyzed who had surgical intensive care unit admission. | days | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Narcotic Use | PCA Only | 3.7 | Standard Deviation 3.5 | mg/24 hours over days 1-3 | |
| Narcotic Use | Bupivicaine 0.25% (LOW DOSE) | 8.2 | Standard Deviation 5.16 | mg/24 hours over days 1-3 | |
| Narcotic Use | Bupivicaine 0.5% (HIGH DOSE) | 2.5 | Standard Deviation 0 | mg/24 hours over days 1-3 | |
| Time to Improvement in Pulmonary Function | PCA Only | 1.7 | Standard Deviation 1.5 | days | |
| Time to Improvement in Pulmonary Function | Bupivicaine 0.25% (LOW DOSE) | 1.8 | Standard Deviation 1.6 | days | |
| Time to Improvement in Pulmonary Function | Bupivicaine 0.5% (HIGH DOSE) | 1.0 | Standard Deviation 0 | days | |
| Time to Improvement in Pain Intensity | PCA Only | 2.0 | Standard Deviation 0 | days | |
| Time to Improvement in Pain Intensity | Bupivicaine 0.25% (LOW DOSE) | 3.0 | Standard Deviation 0 | days | |
| Time to Improvement in Pain Intensity | Bupivicaine 0.5% (HIGH DOSE) | 1.0 | Standard Deviation 0 | days | |
| Morbidity | PCA Only | 0 | number of complications |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PCA Only | 3 | |
| Overall Study | STARTED | Bupivicaine 0.25% (LOW DOSE) | 5 | |
| Overall Study | STARTED | Bupivicaine 0.5% (HIGH DOSE) | 2 | |
| Overall Study | COMPLETED | PCA Only | 3 | |
| Overall Study | COMPLETED | Bupivicaine 0.25% (LOW DOSE) | 5 | |
| Overall Study | COMPLETED | Bupivicaine 0.5% (HIGH DOSE) | 1 | |
| Overall Study | NOT COMPLETED | PCA Only | 0 | |
| Overall Study | NOT COMPLETED | Bupivicaine 0.25% (LOW DOSE) | 0 | |
| Overall Study | NOT COMPLETED | Bupivicaine 0.5% (HIGH DOSE) | 1 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | PCA Only | 0 | 3 | 0 |
| other | Constipation | Gastrointestinal disorders | Bupivicaine 0.25% (LOW DOSE) | 1 | 5 | 1 |
| other | Constipation | Gastrointestinal disorders | Bupivicaine 0.5% (HIGH DOSE) | 0 | 1 | 0 |
| other | Low urine output | Renal and urinary disorders | PCA Only | 0 | 3 | 0 |
| other | Low urine output | Renal and urinary disorders | Bupivicaine 0.25% (LOW DOSE) | 1 | 5 | 1 |
| other | Low urine output | Renal and urinary disorders | Bupivicaine 0.5% (HIGH DOSE) | 0 | 1 | 0 |
| other | Anemia | Blood and lymphatic system disorders | PCA Only | 0 | 3 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Bupivicaine 0.25% (LOW DOSE) | 1 | 5 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Bupivicaine 0.5% (HIGH DOSE) | 0 | 1 | 0 |
| other | Urinary Retention | Renal and urinary disorders | PCA Only | 1 | 3 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PCA Only | ||
| Total, all-cause mortality | Bupivicaine 0.25% (LOW DOSE) | ||
| Total, all-cause mortality | Bupivicaine 0.5% (HIGH DOSE) | ||
| Total, other adverse events | PCA Only | 1 | 3 |
| Total, other adverse events | Bupivicaine 0.25% (LOW DOSE) | 2 | 5 |
| Total, other adverse events | Bupivicaine 0.5% (HIGH DOSE) | 0 | 1 |
| Total, serious adverse events | PCA Only | 0 | 3 |
| Total, serious adverse events | Bupivicaine 0.25% (LOW DOSE) | 0 | 5 |
| Total, serious adverse events | Bupivicaine 0.5% (HIGH DOSE) | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02604589
GET https://conductscience.org/api/trials/v1/NCT02604589/registered