Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks

Post-operative Pain Clinical Trial

Official title:

Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876746
• Other study ID #: Supra / Infra Catheters
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2009
• Last updated: June 14, 2010
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: April 2009
• 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 research study is to determine if the insertion site of a perineural catheter or tiny tube placed next to the nerves that go to the part of the body (hand or arm) having surgery, affects the amount of pain relief that is experienced after surgery. Catheters will be placed in either the supraclavicular or infraclavicular location.

Description:

To determine if a particular perineural local anesthetic catheter location (supraclavicular or infraclavicular) will maximize postoperative analgesia, minimize oral opioid requirements, minimize sleep disturbances resulting from postoperative pain, and maximize patient satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• unilateral, upper (at or distal to the elbow) extremity orthopedic surgery with moderate-to-severe postoperative pain expected

• patients already agree to and want a continuous brachial plexus block for postoperative analgesia

Exclusion Criteria:

• patients who have difficulty understanding the study protocol or caring for the infusion pump/catheter system

• patients who have any known contraindication to study medications

• insulin-dependent diabetes mellitus

• neuropathy of any etiology in the affected extremity

• contraindication to regional blockade (e.g. clotting deficiency)

• any known acute or chronic hepatic or renal insufficiency or failure

• any incision site outside of the catheter-effected area

• chronic opioid use

• history of opioid abuse

• obesity

• pregnancy

• incarceration

• inability to communicate with the investigators and hospital staff

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain
• Upper-extremity Surgery

Intervention

Procedure:
• Supraclavicular vs. Infraclavicular ropivicaine infusion
Patients will be randomized to one of two groups: nerve blocks in the supraclavicular location or the infraclavicular location. Following surgery the patient will be called by study staff to assess pain scores, sleep disturbances, infusion side effects, feeling in fingers and other study outcomes.

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	Surgical pain as measured on a 0-10 scale where 0=no pain and 10=worst imaginable pain. The values for the two different catheter locations will be compared to see which site is optimal for catheter placement.		3 days	No
Secondary	Opioids consumed by patient each day after surgery as reported to study staff.		3 days	No
Secondary	Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff.		3 days	No
Secondary	Infusion side effects (shortness of breath) as reported to study staff.		3 day	No
Secondary	Satisfaction with pain control as measured on a 0-10 scale where 0=very unsatisfied and 10=very satisfied, as reported to study staff at time of daily phone calls		3 days	No
Secondary	Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff.		3 days	No
Secondary	Catheter site discomfort, leakage at catheter site, and catheter related pain on the 0-10 rating scale, where 0=no pain and 10=worst imaginable pain, as reported to study staff during phone calls.		3 days	No