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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01277159
First received: January 13, 2011
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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?

Secondary outcomes:

Does adding dexamethasone and/or buprenorphine to a popliteal fossa nerve block improve: Pain scores? Quality of recovery? Satisfaction?

Does adding dexamethasone and/or buprenorphine to a popliteal fossa nerve reduce:Opioid consumption? Opioid-related symptoms? Sleep disturbance?


Condition Intervention
Patients Undergoing Ankle Surgery
 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: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Time it takes for nerve block to wear off [ Time Frame: 12-36 hours ] [ Designated as safety issue: No ]
    Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?


Enrollment: 108
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: A. Control Nerve Block. IV Dexamethasone (4 mg).
    A. Control Nerve Block. IV Dexamethasone (4 mg).
    Drug: B. Nerve Block with Dexamethasone (4 mg). IV saline.
    B. Nerve Block with Dexamethasone (4 mg). IV saline.
    Drug: C. 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)
    Drug: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
    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).
    E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of Dr Levine or Dr Roberts.
  2. Scheduled for discharge from HSS after foot or ankle surgery.
  3. A single-injection popliteal fossa nerve block is judged appropriate.
  4. Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
  5. 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277159

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01277159     History of Changes
Other Study ID Numbers: 10105
Study First Received: January 13, 2011
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:
Analgesia
Duration
Popliteal Fossa Nerve Block
Dexamethasone
 Buprenorphine
Additives
Ankle surgery

Additional relevant MeSH terms:
Buprenorphine
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
 Narcotic Antagonists
Narcotics
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013