Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

NCT00997867 | Completed Phase 4

• 1 other identifier: Catheter Insertion Distance
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to determine if the effects of continuous peripheral nerve blocks are influenced by the distance of insertion past the needle tip of the perineural catheter.

Conditions

Lower Extremity Surgery; Upper Extremity Surgery; Post-operative Pain

Keywords

Pain; Surgery; Catheter; Nerve Block; Popliteal; Sciatic; Femoral; Interscalene; UCSD; Moderate-to-severe pain; Perineural Catheter; Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

• Average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).

  Day 1 after surgery, 3 hours prior to phone call

Study Arms (2)

Catheter 0-1cm past needle tip

ACTIVE COMPARATOR

Patients will be receiving a sciatic (popliteal), femoral, or interscalene nerve block and will be randomized to having the catheter placed 0-1cm past the needle tip. The patient will be called the following day by research staff to assess their post-surgical pain.

Procedure: Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip

Catheter placed 5-6cm past needle tip

ACTIVE COMPARATOR

Patients will be receiving a sciatic (popliteal), femoral, or interscalene nerve block and will be randomized to having the catheter placed 5-6cm past the needle tip. Patients will be called the following day by research staff to assess their post-surgical pain.

Procedure: Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip

Interventions

Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip PROCEDURE

Patients undergoing orthopedic surgery who are getting a perineural catheter will be randomized to one of two groups: catheter tip placed 0-1cm past needle tip or catheter tip placed 5-6cm past needle tip. Patients will be called by research staff the day following surgery to assess their post-surgical pain using a numeric rating scale.

Catheter 0-1cm past needle tip; Catheter placed 5-6cm past needle tip

Eligibility Criteria

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

You may qualify if:

• undergoing surgery with a planned popliteal perineural catheter for postoperative analgesia
• age 18 years or older

You may not qualify if:

• pregnancy
• inability to communicate with the investigators and hospital staff
• incarceration
• clinical neuropathy in the surgical extremity
• chronic high-dose opioid use
• history of opioid abuse

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian M Ilfeld, M.D., M.S.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2009
• First Posted: October 19, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 28, 2010

Record last verified: 2010-10

Locations

US (1)