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

NCT ID: NCT03376178

Last Updated: 2017-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain

Keywords

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multiorifice or endhole femoral nerve catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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six-hole group

lidocaine and ropivacaine injection through catheters

Group Type EXPERIMENTAL

lidocaine and ropivacaine injection through catheters

Intervention Type 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

lidocaine and ropivacaine injection through catheters

Group Type ACTIVE_COMPARATOR

lidocaine and ropivacaine injection through catheters

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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FOURNIER ROXANE

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Tramer

Role: STUDY_DIRECTOR

Anesthesiology department Of University Hospital of Geneva

Locations

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University hospitals of Geneva

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 20966667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9952105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24875973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16140191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20889937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17578984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17312228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21112881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21857268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2774123 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30567487 (View on PubMed)

Other Identifiers

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FROXANE

Identifier Type: -

Identifier Source: org_study_id