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Phase 4 N=100 Randomized Double-blind Treatment

Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures

Pain, Postoperative · Ankle Fractures

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Post-operative Visual Analog Pain Scores (VAS) — 42; 52; 41; 50 0 to 100 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ropivacaine (Drug); Epinephrine (Drug); Morphine (Drug); 0.9% sodium chloride solution (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Iowa
Primary completion
Sep 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Post-operative Visual Analog Pain Scores (VAS)
42; 52; 41; 50
SECONDARY
Opioid Use in First 24 Hours Post-surgery
25.5; 28.3; 29.0; 32.7
SECONDARY
Post-operative Length of Stay
22.3; 22.5
SECONDARY
Patients Returning Home Following Surgery
49; 46

Summary

The purpose of this study is to determine the efficacy and safety of a peri-articular multimodal injection for post-operative pain control following operative management of closed, rotational ankle fractures. Enrolled subjects will be randomized to either receive or not receive intra-operative injections in addition to standard opioid analgesic regimens. Patients will be treated with standard of care surgical techniques by the treating orthopaedic surgeon for the patient's specific fracture pattern. The patients randomized into the injection cohort will receive a 25cc intra-operative injection with 200 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional tissues while under general anesthesia. Total post-operative opioid consumption expressed in morphine equivalent dose will be recorded, including IV and oral opioids. Time in hours from operation conclusion to discharge and discharge disposition (to where the patient is discharged) will also be recorded. Post-operative pain scores will be assessed and recorded in the immediate post-operative period and every 4 hours subsequently until the patient is discharged. Medication related side effects will be monitored. The investigators hypothesize that the injection cohort will have reduced pain scores, lower narcotic requirements, shorter length of stay, and be more likely to discharge to home following surgery.

Eligibility Criteria

Inclusion Criteria

  • All consenting patients 18 years of age and older with operative, closed, rotational ankle fractures treated with internal fixation.

Exclusion Criteria

  • Patients with any of the following:
  • Allergy or medical contraindication to any of the study medications
  • Pregnant women
  • Diagnosed dementia
  • Preexisting opioid or illicit drug dependency
  • Major neuromuscular deficit
  • Severe systemic disorder (heart failure, respiratory failure, kidney failure, liver failure, or a clotting disorder)
  • Major head trauma
  • Concomitant distracting injury
  • Other surgical intervention in the study period (1 week)
  • Revision operations
  • Insists to receive peripheral nerve blocks for surgical anesthesia
  • Refusal to participate
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02967172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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