Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497276
Status:
COMPLETED
Last Update Posted:
2009-12-21
First Post:
2007-07-04
Brief Title:
Comparison of Ultrasound and Nerve Stimulation Technique for Continuous Sciatic Nerve Block
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
A Prospective Randomized Comparison of Ultrasound Versus Nerve Stimulation Guidance of Popliteal Sciatic Catheter Placement After Major Foot and Ankle Surgery Clinical Outcome and Cost Analysis
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The most useful method to manage pain after major foot and ankle surgery is infusion of local anesthetic with a catheter close to the sciatic nerve in the popliteal space above the knee joint
Inaccurate catheter placement and spread of local anesthetic account for most failures
The most prevalent method to place the catheter is the traditional nerve stimulation technique relying on surface anatomic landmarks and electrical stimulation to localize the sciatic nerve In recent years ultrasound technique has been applied to provide real-time visual guidance of catheter placement
The purpose of this randomized controlled trial is to compare the success rate patient acceptance and cost-effectiveness of the ultrasound and nerve stimulation techniques
Inaccurate catheter placement and spread of local anesthetic account for most failures
The most prevalent method to place the catheter is the traditional nerve stimulation technique relying on surface anatomic landmarks and electrical stimulation to localize the sciatic nerve In recent years ultrasound technique has been applied to provide real-time visual guidance of catheter placement
The purpose of this randomized controlled trial is to compare the success rate patient acceptance and cost-effectiveness of the ultrasound and nerve stimulation techniques
Detailed Description:
Foot and ankle surgery is typically very painful for the first two days postoperatively due to surgical oedema This pain is difficult to control with systemic analgesics Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids sedation nausea vomiting obstipation urinary retention mouth dryness respiratory depression pruritus vertigo and visual disturbances
Single-shot technique provides analgesia for two to 30 hours even using analgesics with prolonged effect bupivacaine levobupivacaine ropivacaine The duration of the block depends on the local analgesic and the anatomical location Popliteal block with bupivacaine last up to 24 hours Continuous peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics and their adverse effects Continuous peripheral nerve block has gained popularity for foot and ankle surgery because better analgesia is obtained compared to intravenous opioids and similar analgesia with fewer adverse effects compared to epidural catheter technique
Today the nerve stimulation technique is the most prevalent technique to introduce catheters for peripheral nerve blocks The success rate for postoperative analgesia after foot and ankle surgery with popliteal catheters is variable - typically 70 in our department The patients with catheter failure have severe postoperative pain high opioid dosages cognitive blurring nausea vomiting reduced ambulation increased surgical stress response and increased morbidity Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge
Ultrasound technique was employed for peripheral nerve blocks for the first time in 1978 However the utility was technically limited In recent years the evolution of high-frequency transducers and mobile ultrasound units have facilitated the application of ultrasound-guided peripheral nerve blocks This technique allows dynamic visualization of nerves needle tip location and spread of local analgesic in real-time
The empirical basis supporting the theoretical advantages of ultrasound-guided regional anesthesia consists mainly of observational studies A few randomized controlled trials comparing ultrasound- and nerve stimulation technique favour the benefit of ultrasound concerning success rate sensory onset time duration of block patient satisfaction and quality of block
The purpose of this study is to establish whether ultrasound technique has higher success rate better patient satisfaction and higher cost-effectiveness compared to electrical nerve stimulation using popliteal sciatic catheters for postoperative analgesia after foot and ankle surgery
Single-shot technique provides analgesia for two to 30 hours even using analgesics with prolonged effect bupivacaine levobupivacaine ropivacaine The duration of the block depends on the local analgesic and the anatomical location Popliteal block with bupivacaine last up to 24 hours Continuous peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics and their adverse effects Continuous peripheral nerve block has gained popularity for foot and ankle surgery because better analgesia is obtained compared to intravenous opioids and similar analgesia with fewer adverse effects compared to epidural catheter technique
Today the nerve stimulation technique is the most prevalent technique to introduce catheters for peripheral nerve blocks The success rate for postoperative analgesia after foot and ankle surgery with popliteal catheters is variable - typically 70 in our department The patients with catheter failure have severe postoperative pain high opioid dosages cognitive blurring nausea vomiting reduced ambulation increased surgical stress response and increased morbidity Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge
Ultrasound technique was employed for peripheral nerve blocks for the first time in 1978 However the utility was technically limited In recent years the evolution of high-frequency transducers and mobile ultrasound units have facilitated the application of ultrasound-guided peripheral nerve blocks This technique allows dynamic visualization of nerves needle tip location and spread of local analgesic in real-time
The empirical basis supporting the theoretical advantages of ultrasound-guided regional anesthesia consists mainly of observational studies A few randomized controlled trials comparing ultrasound- and nerve stimulation technique favour the benefit of ultrasound concerning success rate sensory onset time duration of block patient satisfaction and quality of block
The purpose of this study is to establish whether ultrasound technique has higher success rate better patient satisfaction and higher cost-effectiveness compared to electrical nerve stimulation using popliteal sciatic catheters for postoperative analgesia after foot and ankle surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None