Continuous L2 Paravertebral Block Versus Continuous Lumbar Plexus Block for Postoperative Analgesia
5 juin 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15232
- UPMC Presbyterian Shadyside
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative Opiate consumption
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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NRS Pain Score (at rest)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2009
Achèvement primaire (Réel)
1 octobre 2010
Achèvement de l'étude (Réel)
1 juin 2015
Dates d'inscription aux études
Première soumission
2 avril 2012
Première soumission répondant aux critères de contrôle qualité
4 avril 2012
Première publication (Estimation)
5 avril 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juin 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 juin 2017
Dernière vérification
1 juin 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- PRO09010511
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