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Perineural Local Anesthetic Administration With a Continuous Infusion Versus Automatic Intermittent Boluses

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ClinicalTrials.gov Identifier: NCT04458467
Recruitment Status : Enrolling by invitation
First Posted : July 7, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:
This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to automated boluses with PCA for continuous popliteal sciatic nerve blocks. The goal will be to determine the relationship between method of local anesthetic administration (continuous with PCA initiated at discharge vs. intermittent dosing with PCA with a 5-hour delay) for continuous peripheral nerve block and the resulting pain control and duration of analgesia.

Condition or disease Intervention/treatment Phase
Pain, Acute Anesthesia, Local Trauma Injury Device: Continuous Infusion Device: Automated Intermittent Boluses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perineural Local Anesthetic Administration With a Continuous Infusion Versus Automatic Intermittent Boluses
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 21, 2021

Arm Intervention/treatment
Active Comparator: Continuous Infusion
Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout).
Device: Continuous Infusion
A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.

Experimental: Automated Boluses
Patients will receive intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Device: Automated Intermittent Boluses
Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).




Primary Outcome Measures :
  1. Average Pain queried on First postoperative day [ Time Frame: postoperative day 1 ]
    Rated 0-10 on numeric rating scale the average pain from the recovery room until the data collection call

  2. Duration of Infusion [ Time Frame: 6 days postoperatively ]
    Number of hours from the time the pump is initiated until local anesthetic reservoir exhaustion


Secondary Outcome Measures :
  1. Worst Pain [ Time Frame: Each of 6 days postoperatively ]
    Rated 0-10 on numeric rating scale

  2. Average Pain [ Time Frame: Each of 6 days postoperatively ]
    Rated 0-10 on numeric rating scale

  3. Least Pain [ Time Frame: Each of 6 days postoperatively ]
    Rated 0-10 on numeric rating scale

  4. Current Pain [ Time Frame: Each of 6 days postoperatively ]
    Rated 0-10 on numeric rating scale

  5. Opioid Consumption [ Time Frame: Each of 6 days postoperatively ]
    Cumulative opioid consumption during the first 6 days postoperatively

  6. Sleep disturbances due to pain [ Time Frame: Each of 6 nights postoperatively ]
    Number of awakenings due to pain during the first 6 nights postoperatively

  7. Numbness in foot and ankle [ Time Frame: Each of 6 days postoperatively ]
    Rate 0 = normal to 10 = insensate



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

Inclusion Criteria:

  • patients undergoing painful foot and/or ankle surgery with a planned popliteal sciatic perineural catheter for postoperative analgesia
  • age 18 years or older.

Exclusion Criteria:

  • Current daily opioid use within the previous 4 weeks
  • Clinical neuro-muscular deficit of either the sciatic nerve and its branches and/or innervating muscles
  • Morbid obesity [weight > 35 kg/m2]; surgery outside of ipsilateral sciatic and saphenous nerve distributions
  • Pregnancy [as determined by a urine pregnancy test prior to any study interventions]
  • Incarceration.

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): NCT04458467


Locations
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United States, California
UCSD Medical Center (Hillcrest and Thornton)
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Brian M Ilfeld, MD, MS University California San Diego
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor in Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04458467    
Other Study ID Numbers: Auto Intermittent Boluses
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations