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Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

Primary Purpose

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

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Lower Extremity Surgery focused on measuring Pain, Surgery, Catheter, Nerve Block, Popliteal, Sciatic, Femoral, Interscalene, UCSD, Moderate-to-severe pain, Perineural Catheter, Orthopedic Surgery

Eligibility Criteria

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

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

Sites / Locations

UCSD Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Catheter 0-1cm past needle tip

Catheter placed 5-6cm past needle tip

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00997867

First Posted

October 18, 2009

Last Updated

October 27, 2010

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT00997867

Brief Title

Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

Official Title

Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of California, San Diego

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Catheter 0-1cm past needle tip

Arm Type

Active Comparator

Arm Description

Arm Title

Catheter placed 5-6cm past needle tip

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian M Ilfeld, M.D., M.S.

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD Medical Center

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

12. IPD Sharing Statement

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Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

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