Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine

Study Overview
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Brief Summary
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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?

Official Title
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Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine

Conditions
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Patients Undergoing Ankle Surgery

Intervention / Treatment
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* Drug: 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).


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Nerve Block. IV Dexamethasone (4 mg).<br>Control Nerve Block. IV Dexamethasone (4 mg). | Drug: A. Control Nerve Block. IV Dexamethasone (4 mg).<br>* A. Control Nerve Block. IV Dexamethasone (4 mg).<br>|
| Experimental: Nerve Block with Dexamethasone (4 mg). IV saline.<br>B. Nerve Block with Dexamethasone (4 mg). IV saline. | Drug: B. Nerve Block with Dexamethasone (4 mg). IV saline.<br>* B. Nerve Block with Dexamethasone (4 mg). IV saline.<br>|
| Experimental: Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp<br>Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) | Drug: C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)<br>* C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)<br>|
| Experimental: Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (<br>Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). | Drug: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).<br>* D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).<br>|
| Experimental: Nerve Block with Dexamethasone (4 mg) / block Buprenorphine<br>Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. | Drug: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).<br>* E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time it Takes for Nerve Block to Wear Off | Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block? | up to 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Duration, Popliteal Fossa Nerve Block, Dexamethasone, Buprenorphine, Additives, Ankle surgery