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Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

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ClinicalTrials.gov Identifier: NCT02198235
Recruitment Status : Completed
First Posted : July 23, 2014
Results First Posted : February 29, 2016
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
This study looks at addition of medications to the local anesthetic for the nerve blockade.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone Drug: Buprenorphine Phase 1

Detailed Description:

Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also receive additional pain pills, including narcotics as needed. This study looks at addition of medications to the local anesthetic for the nerve blockade. The investigators hope that these medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve block. There are 3 groups in the study. One group is a control, and receives usual therapy: nerve block + pain pills. This is typically what the patient would receive as standard care if they were not in the study. One group uses a nerve block with additives (+ pain pills). One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or indirectly acts on the brain.

Patients will be followed while in the hospital, and contacted by telephone and/or email after discharge for 2-3 days. Patients will be asked about their pain levels and the duration of their block. The investigators will enroll 90 patients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Prolonged Popliteal Fossa Nerve Blockade
Study Start Date : October 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control NB + IV Dex + IV Bup
IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Drug: Dexamethasone
Drug: Buprenorphine
Active Comparator: Control NB + IV Dex
IV Dexamethasone (4 mg)
Drug: Dexamethasone
Experimental: NB with Dex + Bup in block.
Dexamethasone (4 mg) Buprenorphine (150 mcg)
Drug: Dexamethasone
Drug: Buprenorphine



Primary Outcome Measures :
  1. Numeric Rating Scale (NRS) Pain Score With Movement [ Time Frame: 24 hours after the popliteal block is given ]
    Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)


Secondary Outcome Measures :
  1. Block Duration [ Time Frame: 24 hours and 48 hours after the popliteal block is given ]
    When did the nerve block entirely wear off?

  2. Numeric Rating Scale (NRS) Pain Score at Rest [ Time Frame: 24 hours after the popliteal block is given ]
    Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)

  3. Median Time to Requiring Oral Opioids [ Time Frame: 24 hours after the popliteal block is given ]
    Did patient have pain requiring oral opioids?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery
  • Patients aged 18-75
  • Patients 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)

Exclusion Criteria:

  • < 18 and > 75
  • 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 (e.g. alleged bupivacaine sensitivity, low body weight, etc.)
  • Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent diabetes mellitus, etc.)
  • Patients who have been diagnosed with altered pain perception or have lack of sensation
  • 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)

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): NCT02198235


Locations
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United States, New York
Hospital For Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Jacques YaDeau, MD, PhD Hospital for Special Surgery, New York

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02198235     History of Changes
Other Study ID Numbers: 2012-017
First Posted: July 23, 2014    Key Record Dates
Results First Posted: February 29, 2016
Last Update Posted: June 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
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