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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277159
First Posted: January 14, 2011
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
  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?


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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:


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: up to 72 hours ]
    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)
Arms Assigned Interventions
Experimental: Control Nerve Block. IV Dexamethasone (4 mg).
Control Nerve Block. IV Dexamethasone (4 mg).
Drug: A. 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.
Drug: 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)
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)
Experimental: Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (
Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 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).
Experimental: Nerve Block with Dexamethasone (4 mg) / block Buprenorphine
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).
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01277159     History of Changes
Other Study ID Numbers: 10105
First Submitted: January 13, 2011
First Posted: January 14, 2011
Results First Submitted: March 27, 2017
Results First Posted: August 31, 2017
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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