Phase 1
N=90
Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT02198235 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Numeric Rating Scale (NRS) Pain Score With Movement — 1.9; 1; 1.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Dexamethasone (Drug); Buprenorphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (NRS) Pain Score With Movement |
1.9; 1; 1.3 | — |
| SECONDARY Block Duration |
30; 37.9; 45.6 | — |
| SECONDARY Numeric Rating Scale (NRS) Pain Score at Rest |
1.8; .9; .8 | — |
| SECONDARY Median Time to Requiring Oral Opioids |
25.5; 30; 35.3 | — |
Summary
This study looks at addition of medications to the local anesthetic for the nerve blockade.
Eligibility Criteria
Inclusion Criteria
- Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery
- Patients aged 18-75
- Patients scheduled for discharge from HSS after foot or ankle surgery
- A single-injection popliteal fossa nerve block is judged appropriate
- Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion)
Exclusion Criteria
- 75
- Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft)
- Bilateral surgery
- Chronic pain (defined as regular use of opioid analgesics for > 3 months)
- Chronic use of steroids (defined as regular use of steroids for > 3 months)
- Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine (e.g. alleged bupivacaine sensitivity, low body weight, etc.)
- Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent diabetes mellitus, etc.)
- Patients who have been diagnosed with altered pain perception or have lack of sensation
- Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia)
- Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)
Data sourced from ClinicalTrials.gov (NCT02198235). 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.