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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by VA Palo Alto Health Care System
Sponsor:
Information provided by (Responsible Party):
Edward R. Mariano, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01459523
First received: October 21, 2011
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Pain, Postoperative
Procedure: Proximal placement
Procedure: Short axis ultrasound
Procedure: Long axis
Procedure: Distal placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks

Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Onset time of sensory anesthesia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time for placement [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    A secondary outcome measure will be the time required to insert the perineural catheter using the technique or location assigned.

  • Postoperative pain [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Imaging technique
In one substudy, subjects will be randomly assigned to either short axis or long axis target ultrasound imaging for perineural catheter insertion. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.
Procedure: Short axis ultrasound
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
Procedure: Long axis
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
Active Comparator: Catheter location
In another substudy, subjects will be randomly assigned to receive their perineural catheters either proximally or distally along the same target nerve or plexus.
Procedure: Proximal placement
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
Procedure: Distal placement
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459523

Contacts
Contact: Edward R. Mariano, MD, MAS 650-858-3938 Edward.Mariano@va.gov
Contact: Steven K. Howard, MD 650-493-5000 showard@stanford.edu

Locations
United States, California
VA Palo Alto Health System Recruiting
Palo Alto, California, United States, 94304
Contact: Dr. Steven K. Howard, MD    650-493-5000    showard@stanford.edu   
Principal Investigator: Edward R. Mariano, MD, MAS         
Sponsors and Collaborators
VA Palo Alto Health Care System
Investigators
Principal Investigator: Edward R Mariano, MD, MAS VA Palo Alto Health Care System (VAPAHCS)
  More Information

Publications:
Responsible Party: Edward R. Mariano, Staff Physician, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01459523     History of Changes
Other Study ID Numbers: 21961
Study First Received: October 21, 2011
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:
Peripheral Nerve Block
Perineural Catheter
Orthopedic Surgery
Ultrasound

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014