Clinical trial NCT03121976: A Comparison of US and Evoked Motor Response-guided Placement of Continuous Femoral Nerve Block Following TKA
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Pain
Nerve Pain
Knee Arthroplasty
Nerve Block
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean numeric pain score (NRS)
timeFrame: 24 hours post-block insertion
Secondary outcomes:
measure: Time to perform the block
timeFrame: At the time of block procedure
measure: Sensation over the skin of the thigh to determine sensory block using 3 point grading scale
timeFrame: 30 min post-block insertion
measure: Quadriceps muscle strength to determine motor block using 3 point grading scale
timeFrame: 30 min post-block insertion
measure: Total hydromorphone used (oral and intravenous PCA)
timeFrame: 24 hours post-block
measure: Total hydromorphone used (oral and intravenous PCA)
timeFrame: 48 hours post-block
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Imad Awad, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pham Dang C, Lelong A, Guilley J, Nguyen JM, Volteau C, Venet G, Perrier C, Lejus C, Blanloeil Y. Effect on neurostimulation of injectates used for perineural space expansion before placement of a stimulating catheter: normal saline versus dextrose 5% in water. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):398-403. doi: 10.1097/AAP.0b013e3181b48648.
citation: Dauri M, Fabbi E, Mariani P, Faria S, Carpenedo R, Sidiropoulou T, Coniglione F, Silvi MB, Sabato AF. Continuous femoral nerve block provides superior analgesia compared with continuous intra-articular and wound infusion after anterior cruciate ligament reconstruction. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):95-9. doi: 10.1097/AAP.0b013e31819baf98.
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citation: Casati A, Fanelli G, Koscielniak-Nielsen Z, Cappelleri G, Aldegheri G, Danelli G, Fuzier R, Singelyn F. Using stimulating catheters for continuous sciatic nerve block shortens onset time of surgical block and minimizes postoperative consumption of pain medication after halux valgus repair as compared with conventional nonstimulating catheters. Anesth Analg. 2005 Oct;101(4):1192-1197. doi: 10.1213/01.ane.0000167232.10305.cd.
citation: Cappelleri G, Ghisi D, Ceravola E, Guzzetti L, Ambrosoli AL, Gemma M, Cornaggia G. A randomised controlled comparison between stimulating and standard catheters for lumbar plexus block. Anaesthesia. 2015 Aug;70(8):948-55. doi: 10.1111/anae.13077. Epub 2015 Mar 21.