Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

Post-operative Pain Clinical Trial

Official title:

Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997867
• Other study ID #: Catheter Insertion Distance
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2009
• Last updated: October 27, 2010
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No