A Comparison of US and Evoked Motor Response-guided Placement of Continuous Femoral Nerve Block Following TKA
Primary Purpose
Anesthesia, Pain, Nerve Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound
Ultrasound + Nerve Stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia
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
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound
Ultrasound + Nerve Stimulation
Arm Description
Femoral catheters inserted using ultrasound only
Femoral catheters inserted using ultrasound with nerve stimulation
Outcomes
Primary Outcome Measures
Mean numeric pain score (NRS)
Pain score assessed 24 hours post-block insertion using numeric pain scale from 0-10
Secondary Outcome Measures
Time to perform the block
Time required to perform the block procedure
Sensation over the skin of the thigh to determine sensory block using 3 point grading scale
Sensory block evaluation examined the sensation over the skin of the thigh
Quadriceps muscle strength to determine motor block using 3 point grading scale
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°
Total hydromorphone used (oral and intravenous PCA)
Total amount of hydromorphone consumed within 24 hours post-block
Total hydromorphone used (oral and intravenous PCA)
Total amount of hydromorphone consumed within 48 hours post-block
Full Information
NCT ID
NCT03121976
First Posted
April 4, 2017
Last Updated
April 26, 2017
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT03121976
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2, 2012 (Actual)
Primary Completion Date
December 31, 2012 (Actual)
Study Completion Date
March 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Pain, Nerve Pain, Knee Arthroplasty, Nerve Block
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Femoral catheters inserted using ultrasound only
Arm Title
Ultrasound + Nerve Stimulation
Arm Type
Active Comparator
Arm Description
Femoral catheters inserted using ultrasound with nerve stimulation
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Femoral catheter inserted using ultrasound only
Intervention Type
Device
Intervention Name(s)
Ultrasound + Nerve Stimulation
Intervention Description
Femoral catheter inserted using ultrasound and nerve stimulation
Primary Outcome Measure Information:
Title
Mean numeric pain score (NRS)
Description
Pain score assessed 24 hours post-block insertion using numeric pain scale from 0-10
Time Frame
24 hours post-block insertion
Secondary Outcome Measure Information:
Title
Time to perform the block
Description
Time required to perform the block procedure
Time Frame
At the time of block procedure
Title
Sensation over the skin of the thigh to determine sensory block using 3 point grading scale
Description
Sensory block evaluation examined the sensation over the skin of the thigh
Time Frame
30 min post-block insertion
Title
Quadriceps muscle strength to determine motor block using 3 point grading scale
Description
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 Frame
30 min post-block insertion
Title
Total hydromorphone used (oral and intravenous PCA)
Description
Total amount of hydromorphone consumed within 24 hours post-block
Time Frame
24 hours post-block
Title
Total hydromorphone used (oral and intravenous PCA)
Description
Total amount of hydromorphone consumed within 48 hours post-block
Time Frame
48 hours post-block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imad Awad, MBChB
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 1H1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19920414
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.
Results Reference
background
PubMed Identifier
19282706
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.
Results Reference
background
PubMed Identifier
20966667
Citation
Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18.
Results Reference
background
PubMed Identifier
18534496
Citation
Shum CF, Lo NN, Yeo SJ, Yang KY, Chong HC, Yeo SN. Continuous femoral nerve block in total knee arthroplasty: immediate and two-year outcomes. J Arthroplasty. 2009 Feb;24(2):204-9. doi: 10.1016/j.arth.2007.09.014. Epub 2008 Mar 4. Erratum In: J Arthroplasty. 2016 May;44(3):431. Anaesth Intensive Care. 2016 May;44(3):428-9. J Arthroplasty. 2018 Mar;33(3):e1.
Results Reference
background
PubMed Identifier
20551021
Citation
Carli F, Clemente A, Asenjo JF, Kim DJ, Mistraletti G, Gomarasca M, Morabito A, Tanzer M. Analgesia and functional outcome after total knee arthroplasty: periarticular infiltration vs continuous femoral nerve block. Br J Anaesth. 2010 Aug;105(2):185-95. doi: 10.1093/bja/aeq112. Epub 2010 Jun 14.
Results Reference
background
PubMed Identifier
16551930
Citation
Salinas FV, Liu SS, Mulroy MF. The effect of single-injection femoral nerve block versus continuous femoral nerve block after total knee arthroplasty on hospital length of stay and long-term functional recovery within an established clinical pathway. Anesth Analg. 2006 Apr;102(4):1234-9. doi: 10.1213/01.ane.0000198675.20279.81.
Results Reference
background
PubMed Identifier
10210055
Citation
Boezaart AP, de Beer JF, du Toit C, van Rooyen K. A new technique of continuous interscalene nerve block. Can J Anaesth. 1999 Mar;46(3):275-81. doi: 10.1007/BF03012610.
Results Reference
background
PubMed Identifier
15715632
Citation
Martinez Navas A, Vazquez Gutierrez T, Echevarria Moreno M. Continuous lateral popliteal block with stimulating catheters. Acta Anaesthesiol Scand. 2005 Feb;49(2):261-3. doi: 10.1111/j.1399-6576.2004.00574.x.
Results Reference
background
PubMed Identifier
16192543
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.
Results Reference
background
PubMed Identifier
25810108
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.
Results Reference
background
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A Comparison of US and Evoked Motor Response-guided Placement of Continuous Femoral Nerve Block Following TKA
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