Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

October 27, 2010 updated by: University of California, San Diego
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific Aim: Research study to determine the relationships between perineural catheter insertion distance and subsequent continuous peripheral nerve block effects.

Hypothesis: during ultrasound-guided perineural catheter placement, inserting the catheter 0-1cm past the needle tip is associated with decreased postoperative pain compared with inserting the catheter 5-6cm past the needle tip.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Catheter 0-1cm past needle tip
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
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.
Active Comparator: Catheter placed 5-6cm past needle tip
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: Day 1 after surgery, 3 hours prior to phone call
Day 1 after surgery, 3 hours prior to phone call

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 18, 2009

First Submitted That Met QC Criteria

October 18, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2010

Last Update Submitted That Met QC Criteria

October 27, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Catheter Insertion Distance

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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