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

NCT ID: NCT01459523

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-05-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Short axis ultrasound

Intervention Type: 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.

Long axis

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Proximal placement

Intervention Type: 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.

Distal placement

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Perineural catheter; Ultrasound; Catheter placement technique; Perineural catheter; Ultrasound; Catheter placement technique; Perineural catheter; Ultrasound; Catheter placement technique; Perineural catheter; Ultrasound; Catheter placement technique

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Palo Alto Health Care System

FED

Sponsor Role: lead

Responsible Party

Edward R. Mariano

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward R Mariano, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System (VAPAHCS)

Locations

VA Palo Alto Health System

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11359219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19920423 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19710219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20700680 (View on PubMed)

Other Identifiers

21961

Identifier Type: -

Identifier Source: org_study_id