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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121976
• Other study ID #: 373-2011
• Status: Completed
• Phase: N/A
• First received: April 4, 2017
• Last updated: April 26, 2017
• Start date: January 2, 2012
• Est. completion date: March 31, 2013

Study information

• Verified date: April 2017
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 31, 2013
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Knee Arthroplasty
• Nerve Block
• Nerve Pain
• Neuralgia
• Pain

Intervention

Device:
• Ultrasound
Femoral catheter inserted using ultrasound only
• Ultrasound + Nerve Stimulation
Femoral catheter inserted using ultrasound and nerve stimulation

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. — View 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. — View 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. — View 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):1192-7, table of contents. — View 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. — View Citation

Martínez Navas A, Vázquez Gutierrez T, Echevarría Moreno M. Continuous lateral popliteal block with stimulating catheters. Acta Anaesthesiol Scand. 2005 Feb;49(2):261-3. — View 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. Review. — View 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. — View 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. — View 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: Anaesth Intensive Care. 2016 May;44(3):428-9. J Arthroplasty. 2016 May;44(3):431. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean numeric pain score (NRS)	Pain score assessed 24 hours post-block insertion using numeric pain scale from 0-10	24 hours post-block insertion
Secondary	Time to perform the block	Time required to perform the block procedure	At the time of block procedure
Secondary	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	30 min post-block insertion
Secondary	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°	30 min post-block insertion
Secondary	Total hydromorphone used (oral and intravenous PCA)	Total amount of hydromorphone consumed within 24 hours post-block	24 hours post-block
Secondary	Total hydromorphone used (oral and intravenous PCA)	Total amount of hydromorphone consumed within 48 hours post-block	48 hours post-block