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

NCT03442036 | Completed Results FDA Device

• 1 other identifier: Suture vs Standard Catheters
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia; Sciatic Nerve Block

Keywords

Regional Anesthesia; Sciatic Nerve Block; Continuous Nerve Block; Perineural Catheter

Outcome Measures

Primary Outcomes (1)

• Average Pain

  Pain evaluated using a numeric rating scale with 0 = no pain and 10 = worst imaginable pain

  first two postoperative days combined

Secondary Outcomes (2)

• Opioid Consumption

  first two postoperative days

• Worst Pain

  Postoperative Days 1 and 2

Other Outcomes (1)

• Catheter Dislodgment.

  first two postoperative days

Study Arms (2)

Through-the-Needle Technique

ACTIVE COMPARATOR

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.

Device: Through-the-Needle Technique

Suture-Method Technique

EXPERIMENTAL

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.

Device: Suture-Method Technique

Interventions

Suture-Method Technique DEVICE

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

Suture-Method Technique

Through-the-Needle Technique DEVICE

Perineural catheters are inserted through a straight hollow-bore needle

Through-the-Needle Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Ferrosan Medical Devices, Roskilde, Denmark: collaborator

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

Results Point of Contact

• Title: John J. Finneran IV, MD
• Organization: University of California San Diego

jfinneran@ucsd.edu

4083073004

Study Officials

• John J Finneran IV, MD

  UC San Diego

  STUDY DIRECTOR

• Brian M Ilfeld, MD, MS

  UC San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: April 6, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 5, 2019
• Last Updated: February 17, 2021
• Results First Posted: March 12, 2020

Record last verified: 2021-01

Locations

US (1)