Phase 4
N=100
Single Shot Versus OnQ Pump in Extremity Fractures
Pain · Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02280291 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Change in Score on Visual Analog Scale (VAS) — 3.28; 1.47; 3.62; 3.91 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ankle SSB (Drug); Ankle OnQ (Drug); DR SSB (Drug); DR OnQ (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Score on Visual Analog Scale (VAS) |
3.28; 1.47; 3.62; 3.91; 1.8; 0.62 | — |
| SECONDARY Disability of the Arm, Shoulder and Hand (DASH) Score |
53.97; 62.17; 36.78; 45.69 | — |
Summary
Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a "rebound pain"--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection.
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years old.
- Male or Female
- All racial and ethnic groups
- Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand
- Patients who opt for surgical treatment of their fractures.
- Patients who consent to be randomized.
- Patients who are willing to follow-up for a minimum of 52 weeks.
Exclusion Criteria
- Patients younger than 18 years old.
- Patients who are on chronic opioids
- Patients who abuse opioids
- Patients who are unwilling to follow-up for a minimum of 52 weeks.
- Neurologic condition that could interfere with pain sensation
Data sourced from ClinicalTrials.gov (NCT02280291). 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.