Catheter Orifice Configuration (Six-hole Versus End-hole) on Post-operative Analgesia After Total Knee Arthroplasty.

Pain Clinical Trial

Official title:

Ultrasound-guided Continuous Femoral Nerve Block: The Influence of Catheter Orifice Configuration (Six-hole Versus End-hole) on Post-operative Analgesia After Total Knee Arthroplasty. A Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376178
• Other study ID #: FROXANE
• Status: Completed
• Phase: N/A
• First received: December 12, 2017
• Last updated: December 12, 2017
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multiorifice catheters have been shown to provide superior analgesia and significantly reduce local anesthetic consumption compared with end-hole catheters in epidural studies. This prospective, blinded, randomized study tested the hypothesis that, in continuous femoral nerve block (CFNB) under ultrasound guidance, multiorifice catheter would reduce local anesthetic consumption at 24h compared with end-hole catheter.

Description:

Eighty adult patients (aged ≥18 years) scheduled to undergo primary total knee arthroplasty under a combination of continuous femoral nerve block (CFNB), sciatic nerve block and general anesthesia were randomized to CFNB using either a 3-pair micro-hole (Contiplex, BRAUN®, 20G - 400 mm) or an end-hole (Silverstim VYGON®, 20G - 500 mm) catheter. Once the femoral catheter was sited, a bolus of 20 mL lidocaine 1% was injected. An electronic pump then delivered an automated 5 mL bolus of ropivacaine 0.2% hourly, with 10 mL self-administered patient controlled analgesia boluses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• every patient accepting a conitnuous femoral nerve catheter

Exclusion Criteria:

• pregnancy,

• any contraindication to peripheral nerve blockade,

• pre-existing peripheral nerve neuropathy,

• allergy to LA (study medications),

• ASA score =4,

• neurologic or neuromuscular disease,

• psychiatric disease,

• renal failure,

• hepatic failure,

• chronic opioid therapy,

• NSAID contraindication,

• inability to use a patient controlled analgesia (PCA) device, g

• enu valgum,

• infection at the injection site or

• withdrawal of consent.

Related Conditions & MeSH terms

• Pain

Intervention

Combination Product:
• lidocaine and ropivacaine injection through catheters
injection of local anesthetic through an endhole or a sixhole femoral nerve catheter in the context of total knee replacement. Analgesic properties at 24 and 48h of both groups registered.

Locations

Country	Name	City	State
Switzerland	University hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (10)

Brodner G, Buerkle H, Van Aken H, Lambert R, Schweppe-Hartenauer ML, Wempe C, Gogarten W. Postoperative analgesia after knee surgery: a comparison of three different concentrations of ropivacaine for continuous femoral nerve blockade. Anesth Analg. 2007 Jul;105(1):256-62. — View Citation

Farr J, Jaggers R, Lewis H, Plackis A, Sim SB, Sherman SL. Evidence-based approach of treatment options for postoperative knee pain. Phys Sportsmed. 2014 May;42(2):58-70. doi: 10.3810/psm.2014.05.2058. Review. — View Citation

Fredrickson MJ, Abeysekera A, Price DJ, Wong AC. Patient-initiated mandatory boluses for ambulatory continuous interscalene analgesia: an effective strategy for optimizing analgesia and minimizing side-effects. Br J Anaesth. 2011 Feb;106(2):239-45. doi: 10.1093/bja/aeq320. Epub 2010 Nov 25. — View Citation

Fredrickson MJ, Ball CM, Dalgleish AJ. Catheter orifice configuration influences the effectiveness of continuous peripheral nerve blockade. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):470-5. doi: 10.1097/AAP.0b013e318228d4ce. — View Citation

Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1. — View Citation

Lang SA. Postoperative analgesia following total knee arthroplasty: a study comparing spinal anesthesia and combined sciatic femoral 3-in-1 block. Reg Anesth Pain Med. 1999 Jan-Feb;24(1):97. — View Citation

Michael S, Richmond MN, Birks RJ. A comparison between open-end (single hole) and closed-end (three lateral holes) epidural catheters. Complications and quality of sensory blockade. Anaesthesia. 1989 Jul;44(7):578-80. — View Citation

Mizner RL, Snyder-Mackler L. Altered loading during walking and sit-to-stand is affected by quadriceps weakness after total knee arthroplasty. J Orthop Res. 2005 Sep;23(5):1083-90. Epub 2005 Mar 28. — 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

Sia AT, Lim Y, Ocampo C. A comparison of a basal infusion with automated mandatory boluses in parturient-controlled epidural analgesia during labor. Anesth Analg. 2007 Mar;104(3):673-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total LA consumption at 24h	total ropivacaine consumption at 24h in mL	24h after connecting PCA to the femoral nerve catheter
Secondary	total LA consumption at 48h	total ropivacaine consumption at 48h in mL	48h after connecting PCA to the femoral nerve catheter
Secondary	number of boluses of ropivacaine at 24h	total ropivacaine boluses received at 24h in numbers	24h after connecting PCA to the femoral nerve catheter
Secondary	number of boluses of ropivacaine at 48 h	total ropivacaine boluses received at 48h in numbers	48h after connecting PCA to the femoral nerve catheter
Secondary	quadriceps strength before surgery and 24h and 48h after surgery	quadriceps strength measured with with an electronic dynamometer in N.m and percentage of preblock value of MVIC	quadriceps strenght before performing femoral nerve block and 24 and 48h after performing the block
Secondary	morphine requirements at 24h and 48h	rescue morphine 24h and 48h in mg	morphine consumption at 24h and 48h after completion of surgery