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Single Shot Versus OnQ Pump in Extremity Fractures

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ClinicalTrials.gov Identifier: NCT02280291
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a "rebound pain"--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection.

Condition or disease Intervention/treatment Phase
Pain Fracture Procedure: GA/sedation with a Single Shot, peripheral nerve block Procedure: GA/sedation with continuous, peripheral nerve block Drug: lidocaine Drug: Propofol Drug: Fentanyl Drug: epinephrine, Drug: bupivacaine Device: OnQ infusion system Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Single Shot Peripheral Nerve Block and Continuous Infusion Via a On-Q Pump in Extremity Fracture Operations: a Randomized Prospective Control Trial
Study Start Date : August 2013
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: GA/sedation with a SS block

Intervention-GA/sedation with a Single Shot, peripheral nerve block. The standard single shot block will 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20 cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.

After placement of the regional block, general anesthesia/sedation will be administered and maintained at the discretion of the anesthesiologist. Induction of anesthesia will involve IV propofol (2mg/kg) and fentanyl (1-2mcg/kg). Anesthetic maintenance will involve inhalational agents, IV agents, air, and oxygen. Fentanyl will be the only intraoperative analgesic used and will be dosed as determined by the anesthesiologist.

Procedure: GA/sedation with a Single Shot, peripheral nerve block
A single shot peripheral nerve block will be used as the primary mode of pain control intraoperatively with adjunct pain medications prescribed for the patient to take as needed

Drug: lidocaine
Drug: Propofol
Drug: epinephrine,
Drug: bupivacaine
Experimental: GA/sedation with continuous infusion

Intervention-GA/sedation with continuous, peripheral nerve block. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine + 20 cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5cc. Once the injection is complete, an indwelling catheter will be placed with its tip location confirmed and then secured at the skin.

Neuromuscular blockade will be used at the discretion of the anesthesiologist and will be reversed appropriately. Anesthetic maintenance will involve inhalational agents, IV agents, air, and oxygen. Fentanyl will be the only intraoperative analgesic used and will be dosed as determined by the anesthesiologist.

Procedure: GA/sedation with continuous, peripheral nerve block
A continuous peripheral nerve block delivered by the OnQ infusion system will be given in the post-operative period and removed within 48 hours of surgery. Adjunct pain medications will be prescribed for the patient to take as needed
Other Name: OnQ infusion

Drug: lidocaine
Drug: Fentanyl
Drug: epinephrine,
Drug: bupivacaine
Device: OnQ infusion system



Primary Outcome Measures :
  1. Post-Operative Pain scores changes at 2 weeks and 6 week follow up intervals [ Time Frame: 2 weeks, 6 weeks ]
    Questionnaires asking for number of pain medications taken, visual analog pain scale, and overall satisfaction in the post-operative period are distributed. DASH questionnaire and SMFA are also used to assess functional outcome at follow-up visits



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients at least 18 years old.
  2. Male or Female
  3. All racial and ethnic groups
  4. Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand
  5. Patients who opt for surgical treatment of their fractures.
  6. Patients who consent to be randomized.
  7. Patients who are willing to follow-up for a minimum of 52 weeks.

Exclusion Criteria:

  1. Patients younger than 18 years old.
  2. Patients who are on chronic opioids
  3. Patients who abuse opioids
  4. Patients who are unwilling to follow-up for a minimum of 52 weeks.
  5. Neurologic condition that could interfere with pain sensation

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): NCT02280291


Locations
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United States, New York
Hospital for Joint Diseases
New York, New York, United States, 10003
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Nirmal Tejwani, MD NYU Hospital for Joint Diseases

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02280291    
Other Study ID Numbers: 12-03598
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Lidocaine
Epinephrine
Racepinephrine
Fentanyl
Bupivacaine
Propofol
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents