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Comparing Through-the-Needle With Suture-Method Catheter Designs for Popliteal Nerve Blocks

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: NCT03442036
Recruitment Status : Completed
First Posted : February 22, 2018
Results First Posted : February 10, 2020
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
Ferrosan Medical Devices, Roskilde, Denmark
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE February 15, 2018
First Posted Date  ICMJE February 22, 2018
Results First Submitted Date  ICMJE January 12, 2020
Results First Posted Date  ICMJE February 10, 2020
Last Update Posted Date March 12, 2020
Actual Study Start Date  ICMJE April 6, 2018
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2020)
Average Pain Level on Numeric Rating Scale With 0 = no Pain and 10 = Worst Imaginable Pain (Units on a Scale) [ Time Frame: first two postoperative days ]
Surgical pain will be noninferior within the first 2 days following foot/ankle surgery with a suture-method compared with a through-the-needle perineural catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (the mean "average" pain measured daily with a Numeric Rating Scale).
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
Average Pain Level (NRS) [ Time Frame: first two postoperative days ]
Surgical pain will be noninferior within the first 2 days following foot/ankle surgery with a suture-method compared with a through-the-needle perineural catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (the mean "average" pain measured daily with a Numeric Rating Scale).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • Catheter Dislodgment. [ Time Frame: first two postoperative days ]
    We will also test for noninferiority of the suture method to the through-the-needle perineural catheter on gross catheter dislodgment using a 1-tailed noninferiority test.
  • Opioid Consumption [ Time Frame: first two postoperative days ]
    Opioid consumption will be noninferior within the first 2 days following foot/ankle surgery with a suture-method compared with a through-the-needle perineural catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (cumulative dose).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Through-the-Needle With Suture-Method Catheter Designs for Popliteal Nerve Blocks
Official Title  ICMJE A Randomized, Observer-Masked, Controlled, Parallel-Arm, Clinical Trial Comparing Through-the-Needle With Suture-Method Perineural Catheter Designs for Continuous Popliteal-Sciatic Nerve Blocks
Brief Summary Following painful surgical procedures, postoperative analgesia is often provided with a single-injection peripheral nerve block. Hothe investigatorsver, even with the longest-acting FDA-approved local anesthetic currently available-bupivacaine-the block duration is measured in hours, while the surgical pain may persist for days. A continuous peripheral nerve block allows a prolonged block, consisting of a percutaneously-inserted catheter with its orifice adjacent to a target nerve/plexus through which local anesthetic may be administered. Two basic perineural catheter designs currently exist: (1) catheters that are inserted either through or over a straight hollow-bore needle; and, (2) catheters that are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve ("suture-method" design). To date, a comparison of the relative risks and benefits of these two designs have not been investigated. The investigators therefore propose a randomized, observer-masked, controlled, parallel-arm, clinical trial to compare these two catheter designs when used to provide post-surgical analgesia following foot and ankle surgery.
Detailed Description

This investigation will be a randomized, observer-masked, controlled, parallel-arm, human-subjects clinical trial. Of note, the investigators will be using standard-of-care perineural catheters and local anesthetic under their FDA-approved purpose and do not plan to research a possible change of indication or use of these drugs as part of this research project.

Consenting adults undergoing surgery with a planned popliteal-sciatic perineural catheter placement will be offered enrollment. Study inclusion will be proposed to eligible patients prior to surgery. If a patient desires study participation, written, informed consent will be obtained using a current UCSD IRB-approved ICF.

Following written, informed consent, the investigators will collect baseline anthropomorphic information (age, sex, height, and the investigatorsight). Subjects will be then be randomized using a computer-generated list and opaque, sealed envelopes to one of two treatment groups (blocks of 4, no stratification): perineural catheter insertion using (1) through-the-needle technique or (2) suture technique. All catheters will be placed by a regional anesthesia fellow or resident under the direct supervision and guidance of a regional anesthesia attending (or by the attending him/herself).

All subjects will have a peripheral intravenous (IV) catheter inserted, standard noninvasive monitors applied, supplemental oxygen administered via a nasal cannula or face mask, and positioned prone. Midazolam and fentanyl (IV) will be titrated for patient comfort, while ensuring that patients remain responsive to verbal cues. The area that will be subsequently covered by the catheter dressing will be clipped of hair, if necessary. The ultrasound will be placed to visualize the short axis (cross-section) of the sciatic nerve to identify the sciatic nerve bifurcation which will subsequently be marked, as well as the location 5 cm cephalad to the bifurcation. The area will be cleaned with chlorhexidine gluconate and isopropyl alcohol and a clear, sterile, fenestrated drape applied. The ultrasound probe will be placed to visualize the short-axis (cross-section) of the target nerve(s) and the target for the catheter to intercept the nerve may be anywhere between the bifurcation and 5 cm cephalad to the bifurcation. All catheters will be placed using standard UCSD ultrasound-guided perineural catheter techniques as previously described. Normal saline 5-20 mL will be administered via the needle and/or catheter to allow catheter insertion and/or testing of catheter location (viewed with ultrasound).

Local anesthetic (20 mL, lidocaine 2% with epinephrine 1:200,000-400,000) will be administered via the catheter. A "successful" catheter insertion will be defined as sensory-block onset in the tibial nerve distribution within 30 minutes following the local anesthetic injection. If the nerve block fails, the catheter will be replaced or the patient removed from further study.

An infusion pump will be attached to the patient's perineural catheter and initiated within the recovery room. The pump will provide ropivacaine 0.2% at a 6 mL/h basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout (standard at UCSD). Subjects will be discharged with a prescription for oxycodone 5 mg tablets for supplementary analgesia. Subjects will be contacted via phone for 4 days following surgery to collect study outcome measures: worst, average, least, and current surgical pain (Numeric Rating Scale of 0 to 10, with "0" being no pain and "10" being the worst pain ever experienced), analgesic use (oral opioids and infusion boluses), sleep disturbances, opioid and local anesthetic infusion side effects, local anesthetic leakage, gross catheter dislodgement, sensory and motor block, and satisfaction with pain control. Subjects or their caretakers will remove the catheters at home.

Primary endpoint:

Hypothesis 1: Surgical pain will be noninferior within the first 2 days following foot/ankle surgery with a suture-method compared with a through-the-needle perineural catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (the mean "average" pain measured daily with a Numeric Rating Scale).

Hypothesis 2: Opioid consumption will be noninferior within the first 2 days following foot/ankle surgery with a suture-method compared with a through-the-needle perineural catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (cumulative dose).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized using a computer-generated list and opaque, sealed envelopes to one of two treatment groups (blocks of 4, no stratification): perineural catheter insert using (1) through-the-needle technique or (2) suture technique.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Regional Anesthesia
  • Sciatic Nerve Block
Intervention  ICMJE
  • Device: Suture-Method Technique
    Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve
  • Device: Through-the-Needle Technique
    Perineural catheters are inserted through a straight hollow-bore needle
Study Arms  ICMJE
  • Active Comparator: Through-the-Needle Technique

    Perineural catheters are inserted through a straight hollow-bore needle.

    The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.

    Intervention: Device: Through-the-Needle Technique
  • Experimental: Suture-Method Technique

    Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.

    The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.

    Intervention: Device: Suture-Method Technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 5, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing ambulatory foot or ankle surgery with a popliteal perineural catheter for postoperative analgesia.

Exclusion Criteria:

  • Pregnancy
  • Inability to communicate with research staff
  • Incarceration
  • Clinically apparent neuropathy in the operative extremity
  • Chronic high dose opioid use
  • History of opioid abuse
  • Concurrent surgery outside the block distribution
  • Patients with nerves deeper than 5 cm from the skin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03442036
Other Study ID Numbers  ICMJE Suture vs Standard Catheters
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Brian M. Ilfeld, MD, MS, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Ferrosan Medical Devices, Roskilde, Denmark
Investigators  ICMJE
Study Director: John J Finneran IV, MD UC San Diego
Principal Investigator: Brian M Ilfeld, MD, MS UC San Diego
PRS Account University of California, San Diego
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP