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Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Sciatic Catheter for Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT05091905
Recruitment Status : Not yet recruiting
First Posted : October 25, 2021
Last Update Posted : October 29, 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 patient-titratable automated boluses with patient controlled boluses (PCA) for popliteal-sciatic perineural catheters. The overall goal is to determine the relationship between method of local anesthetic administration (continuous with PCA vs. titratable intermittent dosing with PCA) for popliteal-sciatic perineural catheters and the resulting pain control. The investigators hypothesize that, compared with a traditional fixed, continuous basal infusion initiated prior to discharge, perineural local anesthetic administered with titratable automated boluses at a lower dose and a 5-hour delay following discharge will (1) provide at least noninferior analgesia during the period that both techniques are functioning; and, (2) will result in a longer overall duration of administration [dual primary end points].

Condition or disease Intervention/treatment Phase
Pain, Acute Postoperative Trauma Injury Drug: Continuous Infusion of ropivacaine 0.2% Drug: Titratable Automated Intermittent Boluses of ropivacaine 0.2% Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Unmasked, Active-Controlled Human Subjects Clinical Trial
Masking: None (Open Label)
Masking Description: It will be impossible to mask investigators as they program the infusion pumps based on treatment group assignment; it will be impossible to mask participants as they will either be told how to titrate the bolus doses or not; and it will be impossible to mask the outcome assessor as we need to query patients on their daily bolus dose volume to track changes.
Primary Purpose: Treatment
Official Title: Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Sciatic Catheter for Postoperative Analgesia
Estimated Study Start Date : October 28, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


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).
Drug: Continuous Infusion of ropivacaine 0.2%
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.
Other Name: Perineural local anesthetic infusion

Experimental: Titratable Automated Boluses
Patients will receive patient-titratable intermittent boluses of Ropivacaine 0.2% (8 mL automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).
Drug: Titratable Automated Intermittent Boluses of ropivacaine 0.2%
The pump will provide ropivacaine 0.2% as an automatic 8 mL bolus once every 2 hours and have a 4 mL patient-controlled bolus with a 30 minute lockout. In addition, for those in the titratable automated intermittent bolus group, the infusion pump will be set in a "pause" mode that delays initiation of the automated bolus doses by 5 hours (this can be over-ridden by patients if they would like to initiate their perineural infusion earlier than 5 hours). Lastly, subjects in the titratable automated intermittent bolus group will be able to titrate the volume of their automated bolus up or down within the range of 1-16 mL.
Other Name: Perineural local anesthetic administration




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 (0=no pain, 10=worst imaginable pain)

  2. Duration of local anesthetic administration [ Time Frame: The first 8 days postoperatively ]
    The duration of treatment from when the infusion pump was initially turned on until the local anesthetic reservoir was exhausted [recorded by the infusion pump memory]


Secondary Outcome Measures :
  1. Worst pain [ Time Frame: Each of 9 days postoperatively ]
    Rated 0-10 on numeric rating scale over the previous 24 hours (0=no pain, 10=worst imaginable pain)

  2. Average pain [ Time Frame: Each of 9 days postoperatively ]
    Rated 0-10 on numeric rating scale over the previous 24 hours (0=no pain, 10=worst imaginable pain)

  3. Least pain [ Time Frame: Each of 9 days postoperatively ]
    Rated 0-10 on numeric rating scale over the previous 24 hours (0=no pain, 10=worst imaginable pain)

  4. Current pain [ Time Frame: Each of 9 days postoperatively ]
    Rated 0-10 on numeric rating scale (0=no pain, 10=worst imaginable pain)

  5. Opioid consumption [ Time Frame: Each of 9 days postoperatively ]
    Opioid consumption during the 24 h period prior to the data collection phone call

  6. Cumulative opioid consumption [ Time Frame: The first 9 postoperative days ]
    Cumulative opioids consumed during the first 9 postoperative days

  7. Sleep disturbances due to pain [ Time Frame: The first 9 postoperative evenings queried on the following day ]
    The number of sleep disturbances (awakenings) due to pain the previous night

  8. Satisfaction with analgesia [ Time Frame: The first 9 postoperative days ]
    0-10 scale with 0=very dissatisfied and 10=completely satisfied for the previous 24 hours

  9. Numbness in foot and ankle [ Time Frame: Each of 9 postoperative days ]
    Rate 0 = normal to 10 = insensate for the previous 24 hours

  10. Pain Interference Subscale of the Brief Pain Inventory [ Time Frame: Queried on postoperative days 4 and 7 for the prior 24 hours ]
    Interference with physical and emotional functioning using a 0 to 10 scale (where 0 indicates no interference and 10 indicates complete interference). The seven interference questions involve general activity, mood, walking ability, normal work activities (both inside and outside of the home), relationships, sleep, and enjoyment of life. These seven functioning questions are combined to produce an interference subscale (0 to 70).



Information from the National Library of Medicine

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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

Exclusion Criteria:

  • daily opioid use within the previous 4 weeks
  • clinical neuromuscular deficit of either the sciatic nerve and its branches and/or innervating muscles
  • morbid obesity [body mass index > 35 kg/m2]
  • surgery outside of the ipsilateral sciatic and saphenous nerve distributions [e.g., iliac crest bone graft]
  • pregnancy
  • 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): NCT05091905


Contacts
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Contact: John J Finneran IV, MD (858) 220-5714 jfinneran@health.ucsd.edu
Contact: Brian M Ilfeld, MD, MS (858) 220-5714 bilfeld@health.ucsd.edu

Locations
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United States, California
UCSD Medical Center
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 of California, San Diego
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05091905    
Other Study ID Numbers: Patient-Titrated Boluses cPNB
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: Yes
Additional relevant MeSH terms:
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Acute Pain
Pain, Postoperative
Pain
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents