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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Combination product: lidocaine and ropivacaine injection through catheters

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: six-hole group; lidocaine and ropivacaine injection through catheters	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.
ACTIVE_COMPARATOR: end-hole group; lidocaine and ropivacaine injection through catheters	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total LA consumption at 24h	total ropivacaine consumption at 24h in mL	24h after connecting PCA to the femoral nerve catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total LA consumption at 48h	total ropivacaine consumption at 48h in mL	48h after connecting PCA to the femoral nerve catheter
number of boluses of ropivacaine at 24h	total ropivacaine boluses received at 24h in numbers	24h after connecting PCA to the femoral nerve catheter
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
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
morphine requirements at 24h and 48h	rescue morphine 24h and 48h in mg	morphine consumption at 24h and 48h after completion of surgery

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Study Director: Martin Tramer, Anesthesiology department Of University Hospital of Geneva

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1213/01.ane.0000253236.89376.60.
• 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.
• 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. doi: 10.1016/s1098-7339(99)90176-1. No abstract available.
• 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.
• 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. doi: 10.1016/j.orthres.2005.01.021. Epub 2005 Mar 28.
• 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. doi: 10.1213/01.ane.0000265552.43299.2b.
• 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.
• 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.
• 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. doi: 10.1111/j.1365-2044.1989.tb11446.x.
• Novello-Siegenthaler A, Hamdani M, Iselin-Chaves I, Fournier R. Ultrasound-guided continuous femoral nerve block: a randomized trial on the influence of femoral nerve catheter orifice configuration (six-hole versus end-hole) on post-operative analgesia after total knee arthroplasty. BMC Anesthesiol. 2018 Dec 19;18(1):191. doi: 10.1186/s12871-018-0648-8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2014
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: multiorifice or endhole femoral nerve catheter
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ropivacaine
• Other Study ID Numbers: FROXANE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No