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Completed

NCT Number: NCT00876746

Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks

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.

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Key information

Conditions

Upper-extremity Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSD Medical Center

San Diego, California, 92103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supraclavicular vs. Infraclavicular ropivicaine infusion

Procedure

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.

Primary outcomes

  1. 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.

    Time frame: 3 days

Secondary outcomes

  1. Opioids consumed by patient each day after surgery as reported to study staff.

    Time frame: 3 days

  2. Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff.

    Time frame: 3 days

  3. Infusion side effects (shortness of breath) as reported to study staff.

    Time frame: 3 day

  4. 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

    Time frame: 3 days

  5. Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff.

    Time frame: 3 days

  6. 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.

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 7, 2009
Registry last updated
Jun 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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