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Completed

NCT Number: NCT01459523

Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks

Continuous peripheral nerve blocks (CPNB; also known as "perineural" catheters) provide target-specific pain control for a variety of surgeries. There has been increasing interest in the use of ultrasound guidance for regional anesthesia, and many techniques using ultrasound alone for perineural catheter insertion have been described. Catheters may be placed at various points along the brachial plexus (for upper extremity procedures) or in proximity to the femoral and/or sciatic nerve (for lower extremity procedures). To date, the optimal ultrasound scanning technique, catheter insertion endpoint, catheter placement location per indication, for the majority of ultrasound-guided continuous peripheral nerve blocks remain unknown. This study will help provide important information related to optimal ultrasound scanning techniques and will help identify ways to improve the success rates, onset times, and analgesic effectiveness of these techniques for real patients undergoing surgical procedures.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health System

Palo Alto, California, 94304, United States

About this study

Primary Aim: To determine if there is an optimal scanning technique for ultrasound-guided perineural catheter insertion that will result in the most accurate tip placement in proximity to the target nerve or plexus.

Secondary Aim: To determine if there is an optimal location for ultrasound-guided perineural catheter insertion along a target nerve or plexus that will result in maximum local anesthetic infusion benefits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age;
  • Undergoing unilateral, upper (at or distal to the elbow) or lower (hip or distal) extremity orthopedic surgery, with moderate-to-severe postoperative pain expected; and
  • Desiring a continuous perineural catheter for postoperative analgesia.

Exclusion criteria

  • Patients who will have difficulty understanding the study protocol or caring for the infusion pump/catheter system; or
  • Patients with any known contraindication to study medications, insulin-dependent diabetes mellitus, neuropathy of any etiology in the affected extremity;
  • Patients with a contraindication to regional blockade (eg, clotting deficiency);
  • Patients with any known acute or chronic hepatic or renal insufficiency or failure;
  • Patients with any additional surgical site outside of the catheter-affected area (eg, iliac crest bone graft in addition to hand surgery);
  • Patients with chronic opioid use (defined as daily use for more than 4 weeks prior to surgery) or active illicit substance abuse;
  • Patient weighing < 40 kg;
  • Pregnancy;
  • Incarceration; or
  • Inability to communicate with the investigators and hospital staff.

Treatment and study plan

Proximal placement

Procedure

Subjects assigned to this group will have their perineural catheter placed in a proximal position (higher up in the arm or leg) with ultrasound guidance. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.

Other names: Perineural catheter, Ultrasound, Catheter placement technique

Short axis ultrasound

Procedure

Subjects assigned to this group will have the target nerve or plexus identified in short axis (cross-section) using ultrasound. Perineural catheter insertion will be performed in-plane. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.

Other names: Perineural catheter, Ultrasound, Catheter placement technique

Long axis

Procedure

Subjects assigned to this group will have the target nerve or plexus identified in long axis (longitudinal) using ultrasound. Perineural catheter insertion will be performed in-plane. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.

Other names: Perineural catheter, Ultrasound, Catheter placement technique

Distal placement

Procedure

Subjects assigned to this group will have their perineural catheter placed in a distal position (further down in the arm or leg) with ultrasound guidance. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.

Other names: Perineural catheter, Ultrasound, Catheter placement technique

Primary outcomes

  1. Onset time of sensory anesthesia

    Time frame: 30 minutes

    The primary outcome will be the onset time of sensory anesthesia in the target nerve distribution following injection of a local anesthetic bolus via the perineural catheter.

Secondary outcomes

  1. Time for placement

    Time frame: 30 minutes

    A secondary outcome measure will be the time required to insert the perineural catheter using the technique or location assigned.

  2. Postoperative pain

    Time frame: 1 day

    A secondary outcome will be the surgical pain experienced by subjects as assessed by a 0-10 scale (0=no pain; 10=worst pain imaginable) and amount of opioid medications consumed.

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 25, 2011
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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