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A Comparison of US and Evoked Motor Response-guided Placement of Continuous Femoral Nerve Block Following TKA

Comparison of Continuous Femoral Nerve Block Using Ultrasound Versus Ultrasound and Nerve Stimulation Using Stimulating Catheter in Patients Undergoing Total Knee Arthroplasty: A Prospective Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03121976
Enrollment
82
Registered
2017-04-20
Start date
2012-01-02
Completion date
2013-03-31
Last updated
2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Knee Arthroplasty, Nerve Block, Nerve Pain, Pain

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.

Interventions

DEVICEUltrasound

Femoral catheter inserted using ultrasound only

DEVICEUltrasound + Nerve Stimulation

Femoral catheter inserted using ultrasound and nerve stimulation

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists physical status I to III patients * Aged 18-75 scheduled for unilateral TKA

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Mean numeric pain score (NRS)24 hours post-block insertionPain score assessed 24 hours post-block insertion using numeric pain scale from 0-10

Secondary

MeasureTime frameDescription
Time to perform the blockAt the time of block procedureTime required to perform the block procedure
Sensation over the skin of the thigh to determine sensory block using 3 point grading scale30 min post-block insertionSensory block evaluation examined the sensation over the skin of the thigh
Quadriceps muscle strength to determine motor block using 3 point grading scale30 min post-block insertionMotor 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°
Total hydromorphone used (oral and intravenous PCA)24 hours post-blockTotal amount of hydromorphone consumed within 24 hours post-block

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026