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

NCT03376178 | Completed

• 1 other identifier: FROXANE
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

multiorifice or endhole femoral nerve catheter

Outcome Measures

Primary Outcomes (1)

• total LA consumption at 24h

  total ropivacaine consumption at 24h in mL

  24h after connecting PCA to the femoral nerve catheter

Secondary Outcomes (5)

• total LA consumption at 48h

  48h after connecting PCA to the femoral nerve catheter

• number of boluses of ropivacaine at 24h

  24h after connecting PCA to the femoral nerve catheter

• number of boluses of ropivacaine at 48 h

  48h after connecting PCA to the femoral nerve catheter

• quadriceps strength before surgery and 24h and 48h after surgery

  quadriceps strenght before performing femoral nerve block and 24 and 48h after performing the block

• morphine requirements at 24h and 48h

  morphine consumption at 24h and 48h after completion of surgery

Study Arms (2)

six-hole group

EXPERIMENTAL

lidocaine and ropivacaine injection through catheters

Combination Product: lidocaine and ropivacaine injection through catheters

end-hole group

ACTIVE COMPARATOR

lidocaine and ropivacaine injection through catheters

Combination Product: lidocaine and ropivacaine injection through catheters

Interventions

lidocaine and ropivacaine injection through catheters COMBINATION_PRODUCT

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.

end-hole group; six-hole group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• every patient accepting a conitnuous femoral nerve catheter

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University hospitals of Geneva

Geneva, 1211, Switzerland

Location

Related Publications (11)

• 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.

  PMID: 20966667 BACKGROUND

• 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.

  PMID: 9952105 BACKGROUND

• 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.

  PMID: 24875973 BACKGROUND

• 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.

  PMID: 16140191 BACKGROUND

• 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.

  PMID: 20889937 BACKGROUND

• 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.

  PMID: 17578984 BACKGROUND

• 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.

  PMID: 17312228 BACKGROUND

• 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.

  PMID: 21112881 BACKGROUND

• 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.

  PMID: 21857268 BACKGROUND

• 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.

  PMID: 2774123 BACKGROUND

• 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.

  PMID: 30567487 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Martin Tramer

  Anesthesiology department Of University Hospital of Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigators, patients, and other clinical staff were blinded to the treatment group. The investigator in charge of the patient was unaware of patient allocation. He did not perform the block or open the sealed and opaque envelope, but followed the patient in the ward. An opaque skin dressing was used in order to blind the type of catheter used. End-hole catheter Vygon is white and stiff whereas six-hole catheter contiplex is yellow and flexible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Eighty adult patients (aged ≥18 years) scheduled to undergo primary total knee arthroplasty under a combination of 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 Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)