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NCT Number: NCT00876681

Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks

Research study to determine if pain relief following foot and/or ankle surgery is influenced by the technique used to place perineural catheter. The catheters are placed using ultrasound-guidance or nerve stimulation and the method is selected at random using a computer program. This may help to determine if one of these methods is associated with an increased success rate and incidence of foot numbness during the infusion.

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Key information

Conditions

Postoperative Pain Foot Numbness Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms 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

Specific Aim 1: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and quality of postoperative analgesia during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.

Hypothesis 1: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with decreased pain the morning following moderate-to-severely painful orthopedic surgery as measured with a numeric rating scale.

Specific Aim 2: To determine the relationship between perineural catheter placement technique (ultrasound-guidance and electrical stimulation) and degree of sensory deficit during continuous popliteal-sciatic nerve blocks following moderate-to-severely painful orthopedic surgery.

Hypothesis 2: When inserting a perineural catheter for a continuous peripheral nerve block, the use of electrical stimulation, as compared with ultrasound-guidance, is associated with increased sensory deficit the day following moderate-to-severely painful orthopedic surgery as measured with a simple 0-10 scale (0=no numbness; 10=completely insensate) of the part of the foot with the greatest sensory deficit at the time of the data-collection phone call.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing surgery with a planned popliteal-sciatic perineural catheter for postoperative analgesia
  • Expected postoperative pain to be at least moderate in severity the day following surgery (often not adequately treatable with oral analgesics alone)
  • Age 18 years or older

Exclusion criteria

  • Pregnancy
  • Inability to communicate wiht the investigators and hospital staff
  • Incarceration
  • Current chronic opioid use (daily opioid equivalent of >10mg oxycodone for more than the previous four weeks)
  • History of alcohol or opioid abuse
  • Neuropathy in the surgical extremity
  • Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery

Treatment and study plan

Popliteal catheter placed via ultrasound or electrical stimulation

Procedure

Patients will be randomized to one of two groups: Popliteal-sciatic catheter placed via ultrasound-guidance or placed via electrical stimulation. All patients will be given 40ml of 1.5% mepivicaine prior to surgery and then given a pain pump after surgery containing 0.2% ropivacaine. The patients pain scores will be assessed just prior to surgery and the day following surgery. The time of catheter placement and numbness the patient is experiencing in their foot and toes is also assessed and recorded by research staff.

Primary outcomes

  1. The primary outcome measurement will be the average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (NRS, 0-10, 0=no pain, 10=worst imaginable pain).

    Time frame: 3 hours on day following surgery

Secondary outcomes

  1. Sensory deficit in the operative limb the day following surgery as measured with a simple 0-10 scale (0=no numbness; 10=completely insensate) of the part of the foot with the greatest sensory deficit at time of the data collection phone call.

    Time frame: 1 day

  2. Time for catheter placement. Time will begin when probe is placed on skin for the ultrasound-guidance method and when the nerve stimulation needle is placed on the skin for the electrical stimulation method.

    Time frame: 30 minutes

  3. Catheter placement success rate as assessed by attending physician who will test for sensory deficit.

    Time frame: 30 minutes

  4. Worst pain experienced since the surgery in the surgical limb as measured on the 0-10 NRS as assessed by the research staff when they call the patient the day following surgery.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks: A Randomized, Controlled Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 7, 2009
Registry last updated
Oct 8, 2009

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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