Clinical Trial: Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Ultrasound Guidance Versus Electrical Stimulation for Continuous Popliteal-Sciatic Nerve Blocks: A Randomized, Controlled Trial
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: University of California, San Diego
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
- 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 ]
- Catheter placement success rate as assessed by attending physician who will test for sensory deficit. [ Time Frame: 30 minutes ]
- 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 ]
Original Secondary Outcome:
- Sensory deficit in the operative limb the day following suregyer 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 ]
- 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 ]
- Catheter placement success rate as assessed by attending physician who will test for sensory deficit. [ Time Frame: 30 minutes ]
- 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 ]
Information By: University of California, San Diego
Dates:
Date Received: April 3, 2009
Date Started: April 2008
Date Completion:
Last Updated: October 7, 2009
Last Verified: October 2009