- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01277159
Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine
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?
Study Overview
Status
Conditions
Intervention / Treatment
- 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Hospital for Special Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control Nerve Block. IV Dexamethasone (4 mg).
Control Nerve Block.
IV Dexamethasone (4 mg).
|
A. Control Nerve Block.
IV Dexamethasone (4 mg).
|
Experimental: Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg).
IV saline.
|
B. Nerve Block with Dexamethasone (4 mg).
IV saline.
|
Experimental: Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp
Control Nerve Block.
IV Dexamethasone (4 mg).
IV Buprenorphine (0.3 mg)
|
C. Control Nerve Block.
IV Dexamethasone (4 mg).
IV Buprenorphine (0.3 mg)
|
Experimental: Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (
Nerve Block with Buprenorphine (0.3 mg).
IV Dexamethasone (4 mg).
|
D. Nerve Block with Buprenorphine (0.3 mg).
IV Dexamethasone (4 mg).
|
Experimental: Nerve Block with Dexamethasone (4 mg) / block Buprenorphine
Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline.
|
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time it Takes for Nerve Block to Wear Off
Time Frame: up to 72 hours
|
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
|
up to 72 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Urban, Hospital for Special Surgery, New York
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Buprenorphine
Other Study ID Numbers
- 2012-042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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