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Single Shot Versus OnQ Pump in Extremity Fractures

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.
 
ClinicalTrials.gov Identifier: NCT02280291
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : March 30, 2020
Last Update Posted : March 30, 2020
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 Drug: Ankle SSB Drug: Ankle OnQ Drug: DR SSB Drug: DR OnQ 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: Ankle Single Shot Block (SSB) Drug: Ankle SSB
general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.

Experimental: Ankle OnQ (Continuos Sedation OnQ Pump) Drug: Ankle OnQ
versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.

Experimental: DR SSB Drug: DR SSB
general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.

Experimental: DR OnQ Drug: DR OnQ
versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.




Primary Outcome Measures :
  1. Change in Score on Visual Analog Scale (VAS) [ Time Frame: 2 weeks, 6 weeks ]
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").


Secondary Outcome Measures :
  1. Disability of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 2 Weeks, 6 Weeks ]
    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.



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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
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:
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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
Results First Posted: March 30, 2020
Last Update Posted: March 30, 2020
Last Verified: March 2020

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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