Trial · NCT02793947
Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures
NCT02793947, Phase 4, Completed, University of Iowa; results first posted 2018-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures. Trials, record NCT02793947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02793947
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures
- NCT number
- NCT02793947
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 102 participants, actual
- Lead sponsor
- University of Iowa
- Conditions
- Pain, Postoperative, Femur Fracture
- Interventions
- Ropivacaine, Epinephrine, Morphine, 0.9% sodium chloride solution
- First posted
- 2016-06-08
- Last updated
- 2018-04-05
- Results first posted
- 2018-04-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analog Scale Pain Assessment | Pain assessment will be collected immediately prior to surgery (pre-op), immediately following surgery in the post-anesthesia care unit (PACU), and every 4 hours following surgery for the first two post-operative days (48 hours total; 4H-48H) | Patients will describe their current level of comfort on a 10 point scale while at rest. Zero corresponds to "no pain" and ten corresponds to "the most extreme possible pain." Visual analog scores will be collected by nursing staff who are blinded to the treatment allocation. |
| Secondary | Total Narcotic Consumption | Narcotic consumption will be recorded every 8 hours for the first two post-operative days. | Parenteral and oral narcotic agents will be utilized by patients for post-operative pain control per the standard of care. No alterations in narcotic prescription behavior will be observed for this study. |
| Other | Number of Participants With Medication-related Side Effects | 48 hours following surgery | Patients will be monitored every 15 minutes in the recovery room and every 4 hours for the first two post-operative days by nursing personnel for medication side effects related to ropivacaine toxicity including blurred vision, hearing problems, transient peripheral paralysis, dizziness, convulsion, uncontrolled muscle contraction, hypotension, bradycardia, and new onset arrhythmia. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Analog Scale Pain Assessment | Pain assessment will be collected immediately prior to surgery (pre-op), immediately following surgery in the post-anesthesia care unit (PACU), and every 4 hours following surgery for the first two post-operative days (48 hours total; 4H-48H) | units on a scale | MEDIAN | |
| SECONDARY | Total Narcotic Consumption | Narcotic consumption will be recorded every 8 hours for the first two post-operative days. | mg of morphine | MEAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With Medication-related Side Effects | 48 hours following surgery | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Analog Scale Pain Assessment | Peri-incisional Injection | Pre-op | 5.0 | Inter-Quartile Range 3.0 to 7.0 | units on a scale |
| Visual Analog Scale Pain Assessment | Control (no Injection) | Pre-op | 5.0 | Inter-Quartile Range 2.0 to 7.0 | units on a scale |
| Visual Analog Scale Pain Assessment | Peri-incisional Injection | PACU | 1.6 | Inter-Quartile Range 0 to 4.0 | units on a scale |
| Visual Analog Scale Pain Assessment | Control (no Injection) | PACU | 3.2 | Inter-Quartile Range 1.3 to 5.7 | units on a scale |
| Visual Analog Scale Pain Assessment | Peri-incisional Injection | 4H | 1.0 | Inter-Quartile Range 0 to 3.0 | units on a scale |
| Visual Analog Scale Pain Assessment | Control (no Injection) | 4H | 5.0 | Inter-Quartile Range 2.0 to 7.0 | units on a scale |
| Visual Analog Scale Pain Assessment | Peri-incisional Injection | 8H | 2.0 | Inter-Quartile Range 0 to 4.0 | units on a scale |
| Visual Analog Scale Pain Assessment | Control (no Injection) | 8H | 5.0 | Inter-Quartile Range 2.0 to 6.8 | units on a scale |
| Visual Analog Scale Pain Assessment | Peri-incisional Injection | 12H | 3.5 | Inter-Quartile Range 0 to 5.0 | units on a scale |
| Visual Analog Scale Pain Assessment | Control (no Injection) | 12H | 5.0 | Inter-Quartile Range 2.0 to 8.0 | units on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Peri-incisional Injection | 47 | |
| Overall Study | STARTED | Control (no Injection) | 55 | |
| Overall Study | COMPLETED | Peri-incisional Injection | 45 | |
| Overall Study | COMPLETED | Control (no Injection) | 50 | |
| Overall Study | NOT COMPLETED | Peri-incisional Injection | 2 | |
| Overall Study | NOT COMPLETED | Control (no Injection) | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peri-incisional Injection | 1 | 47 |
| Total, all-cause mortality | Control (no Injection) | 0 | 55 |
| Total, other adverse events | Peri-incisional Injection | 0 | 47 |
| Total, other adverse events | Control (no Injection) | 0 | 55 |
| Total, serious adverse events | Peri-incisional Injection | 0 | 47 |
| Total, serious adverse events | Control (no Injection) | 0 | 55 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Peri-incisional Injection vs Control (no Injection): deaths from any cause | Trial comparisons |
| Peri-incisional Injection vs Control (no Injection): Number of Participants With Medication-related Side Effects | Trial comparisons |
| Peri-incisional Injection vs Control (no Injection): serious adverse events | Trial comparisons |
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/NCT02793947
GET https://conductscience.org/api/trials/v1/NCT02793947/results?page=2