N/A
N=108
Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine
Patients Undergoing Ankle Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01277159 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Time it Takes for Nerve Block to Wear Off — 30.4; 45.1; 32.2; 45.6 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- A. Control Nerve Block. IV Dexamethasone (4 mg). (Drug); B. Nerve Block with Dexamethasone (4 mg). IV saline. (Drug); C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) (Drug); D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). (Drug); E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time it Takes for Nerve Block to Wear Off |
30.4; 45.1; 32.2; 45.6; 45.6 | — |
Summary
Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.
Primary outcome:
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
Eligibility Criteria
Inclusion Criteria
- Patients of Dr Levine or Dr Roberts.
- 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).
- Patients aged 18-75 years.
Exclusion Criteria
- 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 with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).
- Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.)
- 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 (NCT01277159). 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.