Continuous L2 Paravertebral Block Versus Continuous Lumbar Plexus Block for Postoperative Analgesia
5. juni 2017 opdateret af: Jacques E. Chelly, University of Pittsburgh
Continuous L2 Paravertebral Block Versus Continuous Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty
This prospective study is intended to compare the analgesic efficacy, preservation of lower extremity motor power and side-effect profile of L2 Paravertebral lumbar plexus approach compared to Posterior nerve stimulation guided lumbar plexus approach, continuous local anesthetic infusion postoperative analgesia of Total Hip Arthroplasty.
The L2 Paravertebral technique of lumbar plexus block, as part of a multimodal pain treatment, could be a cost-effective alternative with a equal profile of analgesic efficacy and motor power sparing with greater promotion of early achievement of postoperative physical therapy goals.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The nerve stimulator guided technique of continuous lumbar plexus block (LPB) is the accepted standard of care at University of Pittsburgh Medical Center (UPMC) for the management of postoperative analgesia after Total Hip Arthroplasty.
Over 900 continuous lumbar plexus blocks were performed at UPMC Presbyterian Shadyside hospital within the last year alone.
Continuous thoracic paravertebral block (TPVB) is also commonly performed at UPMC Presbyterian Shadyside .
Over 2000 are performed annually for a wide variety of surgical procedures.
Recently authors have suggested that a lumbar paravertebral block (LPVB) may represent an alternative approach to the lumbar plexus.
Indeed the L2 paravertebral approach of the lumbar plexus has been described to provide adequate postoperative analgesia following hip arthroscopic surgery.
However, to date, there is no prospective direct comparison between L2 Lumbar plexus approach and the posterior approach for postoperative analgesia after Total Hip Arthroplasty.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- UPMC Presbyterian Shadyside
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age between 18-75 years
- No contraindications to placement of a lumbar plexus posterior block or paravertebral block.
- ASA status I-III
- Scheduled for open total hip arthroplasty with the same surgeon.
- Patients without painful conditions or chronic use of opioid or antineuropathic medications.
- Patient who are not expected to receive therapeutic anticoagulation in the postoperative period.
- No Known allergies to the medications used in the study.
- Patients willing to receive spinal anesthesia
Exclusion Criteria:
- Age under 18 years or older than 75 years.
- Any contraindication to a placement of continuous lumbar plexus Block.
- American Society of Anesthesiologist physical status IV or greater.
- Chronic painful conditions.
- Preoperative opioid tolerant use.
- Coagulation Abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively.
- Allergy to any of the drugs/agents used study protocol.
- Personal or family history of malignant hyperthermia.
- Serum creatinine greater than 1.4 mg/dl.
- Pregnancy
- Having an altered mental status (not oriented to place, person, or time)
- Any comorbid condition that, in the judgment of the consulting orthopedic surgeon, or intraoperative anesthesiologist, would proscribe the patient from any aspect of the study.
- Patient refusal.
- Lumbar plexus block performed with loss of resistance technique
- Patient requiring postoperative management in the ICU
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: L2 Paravertebral peripheral nerve block
L2 paravertebral peripheral nerve block catheter will be placed.
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A continuous L2 paravertebral catheter will be placed according to UPMC standard of care practices.
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Aktiv komparator: Continuous Lumbar plexus peripheral nerve block
Continuous unilateral lumbar plexus peripheral nerve block catheter will be placed.
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A continuous unilateral lumbar plexus catheter will be placed according to UPMC standard of care practices.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Opiate consumption
Tidsramme: 24 postoperatively
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Postoperative Opiate consumption will be recorded as Morphine IV mg equivalent, for the first 24 hours.
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24 postoperatively
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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NRS Pain Score (at rest)
Tidsramme: 24 and 48 hours postoperatively
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Pain scores at Rest will be recorded at 24 and 48 Hours
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24 and 48 hours postoperatively
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NRS Pain Score during physical therapy
Tidsramme: 24 and 48 hours postoperatively
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Pain scores at Rest and During physical therapy will be recorded at 24 and 48 Hours
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24 and 48 hours postoperatively
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TUG (Timed Up and Go)
Tidsramme: 24 hours postoperatively
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The timed get up and go test is a measurement of mobility.
It includes a number of tasks such as standing from a seating position, walking, turning, stopping, and sitting down which are all important tasks needed for a person to be independently mobile.
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24 hours postoperatively
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Straight Leg Raise(SLR)
Tidsramme: 24 hours postoperatively
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In supine position with the extremity being tested and contralateral flexed LE with foot flat on surface.
Patient is instructed to lift extremity to level of contralateral knee.
Inability to lift entire LE off of the surface to the level of the contralateral knee would be indicative of hip flexor weakness.
If the patient is able to lift LE off of the surface, however the knee flexes/unable to maintain full knee extension, this is indicative of quad weakness.
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24 hours postoperatively
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Long arc quad (LAQ)
Tidsramme: 24 hours postoperatively
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In sitting position at the edge of the bed or chair.
Patient is asked to extend lower leg fully on side that is being tested.
If able, this is indicative that quad function is intact.
If unable to fully extend knee, would indicate quad weakness.
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24 hours postoperatively
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Lee EM, Murphy KP, Ben-David B. Postoperative analgesia for hip arthroscopy: combined L1 and L2 paravertebral blocks. J Clin Anesth. 2008 Sep;20(6):462-5. doi: 10.1016/j.jclinane.2008.04.012.
- Capdevila X, Macaire P, Dadure C, Choquet O, Biboulet P, Ryckwaert Y, D'Athis F. Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation. Anesth Analg. 2002 Jun;94(6):1606-13, table of contents. doi: 10.1097/00000539-200206000-00045.
- Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079.
- Siddiqui ZI, Cepeda MS, Denman W, Schumann R, Carr DB. Continuous lumbar plexus block provides improved analgesia with fewer side effects compared with systemic opioids after hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):393-8. doi: 10.1016/j.rapm.2007.04.008.
- Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.
- Chudinov A, Berkenstadt H, Salai M, Cahana A, Perel A. Continuous psoas compartment block for anesthesia and perioperative analgesia in patients with hip fractures. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):563-8. doi: 10.1016/s1098-7339(99)90050-0.
- Kaloul I, Guay J, Cote C, Fallaha M. The posterior lumbar plexus (psoas compartment) block and the three-in-one femoral nerve block provide similar postoperative analgesia after total knee replacement. Can J Anaesth. 2004 Jan;51(1):45-51. doi: 10.1007/BF03018546. Erratum In: Can J Anaesth. 2005 Jan;52(1):119.
- Farny J, Drolet P, Girard M. Anatomy of the posterior approach to the lumbar plexus block. Can J Anaesth. 1994 Jun;41(6):480-5. doi: 10.1007/BF03011541.
- Mannion S, O'Callaghan S, Walsh M, Murphy DB, Shorten GD. In with the new, out with the old? Comparison of two approaches for psoas compartment block. Anesth Analg. 2005 Jul;101(1):259-64, table of contents. doi: 10.1213/01.ANE.0000153866.38440.43.
- Williams BA, Murinson BB. Diabetes mellitus and subclinical neuropathy: a call for new paths in peripheral nerve block research. Anesthesiology. 2008 Sep;109(3):361-2. doi: 10.1097/ALN.0b013e3181829f0d. No abstract available.
- Zink W, Sinner B, Zausig Y, Graf BM. [Myotoxicity of local anaesthetics: experimental myth or clinical truth?]. Anaesthesist. 2007 Feb;56(2):118-27. doi: 10.1007/s00101-006-1121-5. German.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2009
Primær færdiggørelse (Faktiske)
1. oktober 2010
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
2. april 2012
Først indsendt, der opfyldte QC-kriterier
4. april 2012
Først opslået (Skøn)
5. april 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juni 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juni 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PRO09010511
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .