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Comparison · NCT02793947-sae

Peri-incisional Injection vs Control (no Injection): serious adverse events

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): serious adverse events. Trial comparisons, record NCT02793947-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02793947-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.0756wilson
Risk in group 2000.0653wilson
Risk difference, group 1 minus group 20-0.06530.0756newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: control.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Peri-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. The 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.
047EG000
Group 2Control (no Injection)Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.055EG001

Harm

What it counts
Total, serious adverse events
Time frame

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

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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