A Comparison of US and Evoked Motor Response-guided Placement of Continuous Femoral Nerve Block Following TKA
- Conditions
- AnesthesiaPainNerve PainKnee ArthroplastyNerve Block
- Interventions
- Device: UltrasoundDevice: Ultrasound + Nerve Stimulation
- Registration Number
- NCT03121976
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Brief Summary
The purpose of this study is to determine which technique for catheter placement in continuous femoral nerve block (FNB) is most successful - guidance with (1) ultrasound or (2) nerve stimulation and ultrasound. Sensory and motor assessment scores will be obtained post-FNB. Patient controlled analgesia and opiate consumption is also recorded along with pain scores for the first 48 hour post-FNB.
- Detailed Description
Continuous femoral nerve block (cFNB) is a widely used regional anesthetic technique for many lower limb operations, such as total knee arthroplasty (TKA), anterior cruciate ligament repair, tibial osteotomy and patellar surgery. It provides superior pain relief, faster ambulation, shorter hospital stays and less risk of side effects in comparison to patient controlled analgesia (PCA), local anesthetic wound infiltration, or single shot femoral nerve block (FNB).
Stimulating catheters were introduced in 1999 to provide an objective end point to guide continuous nerve block catheter position by maintaining the desired evoked muscle response with nerve stimulation (NS). The main advantages of stimulating catheters are faster onset of sensory and motor block and reduction of local anesthetic drugs consumption. In recent years the precise insertion of continuous catheters has improved especially with the introduction of ultrasound (US)-guided imaging to regional anesthesia practice and advances in scanning techniques. That led to a call to reduce cost by switching to non-stimulating catheters. However, most studies comparing both catheters lacked anesthetic technique standardization and adequate sample size.
In this prospective randomized controlled trial, we compared postoperative analgesic efficacy and opioids consumption in patients having cFNB insertion using US alone and that of US combined with NS.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- American Society of Anesthesiologists physical status I to III patients
- Aged 18-75 scheduled for unilateral TKA
- History of significant psychiatric problems
- BMI > 40 kg/m^2
- Prior surgery in the inguinal region
- Neurological disease with sensory or motor deficit
- Diabetic neuropathy
- Contraindication to any study medications
- Daily opioid consumption >10 mg PO morphine (or equivalent) for 2 weeks prior to surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound Ultrasound Femoral catheters inserted using ultrasound only Ultrasound + Nerve Stimulation Ultrasound + Nerve Stimulation Femoral catheters inserted using ultrasound with nerve stimulation
- Primary Outcome Measures
Name Time Method Mean numeric pain score (NRS) 24 hours post-block insertion Pain score assessed 24 hours post-block insertion using numeric pain scale from 0-10
- Secondary Outcome Measures
Name Time Method Sensation over the skin of the thigh to determine sensory block using 3 point grading scale 30 min post-block insertion Sensory block evaluation examined the sensation over the skin of the thigh
Quadriceps muscle strength to determine motor block using 3 point grading scale 30 min post-block insertion Motor block evaluation examined quadriceps muscle strength by grading the ability or inability to extend the leg of the limb to be operated on against gravity after the hip is passively flexed at 45°
Time to perform the block At the time of block procedure Time required to perform the block procedure
Total hydromorphone used (oral and intravenous PCA) 48 hours post-block Total amount of hydromorphone consumed within 48 hours post-block
Trial Locations
- Locations (1)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada