Overview

This trial is active, not recruiting.

Condition pain, postoperative
Treatments proximal placement, short axis ultrasound, long axis, distal placement
Sponsor VA Palo Alto Health Care System
Start date October 2011
End date July 2017
Trial size 200 participants
Trial identifier NCT01459523, 21961

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(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.
short axis ultrasound Perineural catheter
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.
long axis Perineural catheter
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.
(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.
proximal placement Perineural catheter
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.
distal placement Perineural catheter
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.

Primary Outcomes

Measure
Onset time of sensory anesthesia
time frame: 30 minutes

Secondary Outcomes

Measure
Time for placement
time frame: 30 minutes
Postoperative pain
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks
Principal investigator Edward R Mariano, MD, MAS
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by VA Palo Alto Health Care System.