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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proximal placement
Short axis ultrasound
Long axis
Distal placement
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Peripheral Nerve Block, Perineural Catheter, Orthopedic Surgery, Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Palo Alto Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Imaging technique

Catheter location

Arm Description

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.

In another substudy, subjects will be randomly assigned to receive their perineural catheters either proximally or distally along the same target nerve or plexus.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time for placement
A secondary outcome measure will be the time required to insert the perineural catheter using the technique or location assigned.
Postoperative pain
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.

Full Information

First Posted
October 21, 2011
Last Updated
April 30, 2021
Sponsor
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01459523
Brief Title
Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks
Official Title
Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Peripheral Nerve Block, Perineural Catheter, Orthopedic Surgery, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaging technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Catheter location
Arm Type
Active Comparator
Arm Description
In another substudy, subjects will be randomly assigned to receive their perineural catheters either proximally or distally along the same target nerve or plexus.
Intervention Type
Procedure
Intervention Name(s)
Proximal placement
Other Intervention Name(s)
Perineural catheter, Ultrasound, Catheter placement technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Short axis ultrasound
Other Intervention Name(s)
Perineural catheter, Ultrasound, Catheter placement technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Long axis
Other Intervention Name(s)
Perineural catheter, Ultrasound, Catheter placement technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Distal placement
Other Intervention Name(s)
Perineural catheter, Ultrasound, Catheter placement technique
Intervention Description
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 Outcome Measure Information:
Title
Onset time of sensory anesthesia
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Time for placement
Description
A secondary outcome measure will be the time required to insert the perineural catheter using the technique or location assigned.
Time Frame
30 minutes
Title
Postoperative pain
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward R Mariano, MD, MAS
Organizational Affiliation
VA Palo Alto Health Care System (VAPAHCS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11359219
Citation
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.
Results Reference
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PubMed Identifier
19920423
Citation
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.
Results Reference
background
PubMed Identifier
19710219
Citation
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.
Results Reference
background
PubMed Identifier
20700680
Citation
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.
Results Reference
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Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks

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