Comparison · NCT02793947-e3436b37
Peri-incisional Injection vs Control (no Injection): Number of Participants With Medication-related Side Effects
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Peri-incisional Injection vs Control (no Injection): Number of Participants With Medication-related Side Effects. Trial comparisons, record NCT02793947-e3436b37. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02793947-e3436b37
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.0787 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000694 | 0.0713 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0713 | 0.0787 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Peri-incisional Injection | A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection. | 0 | 45 | OG000 |
| Group 2 | Control (no Injection) | Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed. | 0 | 50 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Medication-related Side Effects
- Description
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.
- Time frame
- 48 hours following surgery
- Population
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures
- NCT number
- NCT02793947
- Phases
- PHASE4
- Conditions
- Pain, Postoperative, Femur Fracture
- Interventions
- Ropivacaine, Epinephrine, Morphine, 0.9% sodium chloride solution
- Lead sponsor
- University of Iowa
- Results first posted
- 2018-04-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02793947?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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