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

NCT01459523 | Completed

• 1 other identifier: 21961
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

Peripheral Nerve Block; Perineural Catheter; Orthopedic Surgery; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Onset time of sensory anesthesia

  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.

  30 minutes

Secondary Outcomes (2)

• Time for placement

  30 minutes

• Postoperative pain

  1 day

Study Arms (2)

Imaging technique

ACTIVE COMPARATOR

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; Procedure: Long axis

Catheter location

ACTIVE COMPARATOR

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; Procedure: Distal placement

Interventions

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.

Also known as: Perineural catheter, Ultrasound, Catheter placement technique

Catheter location

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.

Also known as: Perineural catheter, Ultrasound, Catheter placement technique

Imaging 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.

Also known as: Perineural catheter, Ultrasound, Catheter placement technique

Imaging 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.

Also known as: Perineural catheter, Ultrasound, Catheter placement technique

Catheter location

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead

Study Sites (1)

VA Palo Alto Health System

Palo Alto, California, 94304, United States

Location

Related Publications (4)

• Grant SA, Nielsen KC, Greengrass RA, Steele SM, Klein SM. Continuous peripheral nerve block for ambulatory surgery. Reg Anesth Pain Med. 2001 May-Jun;26(3):209-14. doi: 10.1053/rapm.2001.22256.

  PMID: 11359219 BACKGROUND

• Mariano ER, Cheng GS, Choy LP, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Lee DK, Maldonado RC, Ilfeld BM. Electrical stimulation versus ultrasound guidance for popliteal-sciatic perineural catheter insertion: a randomized controlled trial. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):480-5. doi: 10.1097/AAP.0b013e3181ada57a.

  PMID: 19920423 BACKGROUND

• Mariano ER, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Abrams RA, Meunier MJ, Maldonado RC, Ferguson EJ, Ilfeld BM. Ultrasound guidance versus electrical stimulation for infraclavicular brachial plexus perineural catheter insertion. J Ultrasound Med. 2009 Sep;28(9):1211-8. doi: 10.7863/jum.2009.28.9.1211.

  PMID: 19710219 BACKGROUND

• Mariano ER, Loland VJ, Sandhu NS, Bishop ML, Lee DK, Schwartz AK, Girard PJ, Ferguson EJ, Ilfeld BM. Comparative efficacy of ultrasound-guided and stimulating popliteal-sciatic perineural catheters for postoperative analgesia. Can J Anaesth. 2010 Oct;57(10):919-26. doi: 10.1007/s12630-010-9364-7. Epub 2010 Aug 11.

  PMID: 20700680 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Edward R Mariano, MD, MAS

  VA Palo Alto Health Care System (VAPAHCS)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

US (1)