Nociceptin Concentration in Synovial Fluid and Plasma
17 marzo 2016 aggiornato da: Julia Caldwell, Milton S. Hershey Medical Center
Nociceptin Concentration in Synovial Fluid and Plasma in Patients Undergoing Primary Total Knee Arthroplasty: A Prospective Pilot Study
Nociceptin/Orphanin is a novel opioid peptide system associated with inflammatory response.
Currently is it uncertain as to the presence of absence of nociceptin in synovial fluid of patients.
Nociceptin levels will be measured pre-operatively and post-operatively in plasma levels of patients receiving primary total knee arthroplasty.
Nociceptin levels will also be measured in synovial fluid levels prior to surgical manipulation.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
This is a prospective observational study where nociceptin levels will be drawn from the patient's serum as well as from the patient's synovial fluid. The blood draws will be completed by the anesthesia team and the synovial fluid and tissue will be obtained by the orthopedic team. The initial blood draw will be in the preoperative area and the second blood draw will be five minutes after the release of the tourniquet. The synovial fluid will be drawn by the surgeon with the first incision. There will be no randomization nor control group.
Endpoints:
- The level or absence of nociceptin in synovial fluid in patients receiving total knee primary arthroplasty will be measured via ELISA in picograms per volume.
- The level or absence of nociceptin in plasma in patients receiving total knee primary arthroplasty both in the preoperative period (less than 1 hour prior to surgery and 5 minutes after the tourniquet is removed) via ELISA in picograms per volume.
- Determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty.
Secondary Study Endpoints:
- Determine the effect if present of history of chronic pain and opioid use on the levels of nociception present in patients' synovial fluid and plasma receiving primary total knee arthroplasty.
- Determine the effect if present of demographic factors on the levels of nociception present in patients' synovial fluid and plasma receiving primary total knee arthroplasty
Tipo di studio
Osservativo
Iscrizione (Effettivo)
22
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Sequential patients receiving primary unilateral knee arthroplasty by the same surgeon
Descrizione
Inclusion Criteria:
- receiving a primary knee joint arthroplasty by Dr. Davis ages 18-80 years hemodynamically stable no joint or other types of infection informed consent received and signed no prior joint arthroplasty at the current surgical site no other surgical intervention planned
Exclusion Criteria:
- prior knee arthroplasty at site outside of desired age range pregnant current infection in joint or other location no desire to participate
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Primary Knee Arthroplasty Patients
Patients who consented, met inclusion and exclusion criteria, had plasma and synovial fluid samples drawn as described in the included protocol.
No interventions were completed.
No changes to standard of care treatment completed.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Nociceptin in Synovial Fluid
Lasso di tempo: The surgeon will make a small incision after the patient has been anesthetized and prepped and draped. He will then withdraw the synovial fluid and then will begin the surgery after the fluid is removed.
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The level or absence of nociceptin in synovial fluid will be measured using ELISA and represented in picograms per volume.
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The surgeon will make a small incision after the patient has been anesthetized and prepped and draped. He will then withdraw the synovial fluid and then will begin the surgery after the fluid is removed.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Nociceptin in Plasma
Lasso di tempo: Blood will be drawn in the preoperative period (approximately up to 1 hour prior to surgery).
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Determine the presence of absence of nociceptin in plasma in patients receiving total knee primary arthroplasty and determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty.
Nociceptin will be measured using ELISA and represented in terms of picograms per volume.
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Blood will be drawn in the preoperative period (approximately up to 1 hour prior to surgery).
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Nociceptin in Plasma
Lasso di tempo: Blood will be drawn 5 minutes after the release of the tourniquet.
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Determine the presence of absence of nociceptin in plasma in patients receiving total knee primary arthroplasty and determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty.
Nociceptin will be measured using ELISA and represented in terms of picograms per volume.
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Blood will be drawn 5 minutes after the release of the tourniquet.
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Patient Demographics
Lasso di tempo: Will be determined in the preoperative period up to one hour prior to surgery.
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Age
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Will be determined in the preoperative period up to one hour prior to surgery.
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Patient Demographics
Lasso di tempo: Will be determined in the preoperative period up to one hour prior to surgery.
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Gender
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Will be determined in the preoperative period up to one hour prior to surgery.
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Patient Demographics
Lasso di tempo: Will be determined in the preoperative period up to one hour prior to surgery
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BMI
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Will be determined in the preoperative period up to one hour prior to surgery
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Patient Pain Scores
Lasso di tempo: One set of preoperative scores will be obtained up to one hour prior to surgery.
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pre-operative pain scores will be determined using the 0-10 verbal analog scale.
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One set of preoperative scores will be obtained up to one hour prior to surgery.
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Patient Pain Scores
Lasso di tempo: One set of post operative pain scores will be obtained up to one hour post emergence from anesthesia.
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post-operative pain scores will be determined using the 0-10 verbal analog scale.
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One set of post operative pain scores will be obtained up to one hour post emergence from anesthesia.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Chiou LC, Liao YY, Fan PC, Kuo PH, Wang CH, Riemer C, Prinssen EP. Nociceptin/orphanin FQ peptide receptors: pharmacology and clinical implications. Curr Drug Targets. 2007 Jan;8(1):117-35. doi: 10.2174/138945007779315605.
- Lin AP, Ko MC. The therapeutic potential of nociceptin/orphanin FQ receptor agonists as analgesics without abuse liability. ACS Chem Neurosci. 2013 Feb 20;4(2):214-24. doi: 10.1021/cn300124f. Epub 2012 Nov 6.
- Kumar N, Smart D, Mason S, McKnight AT, Rowbotham DJ, Lambert DG. Neither nociceptin nor its receptor are present in human synovial fluid or tissue. Br J Anaesth. 1999 Sep;83(3):470-1. doi: 10.1093/bja/83.3.470.
- Verbeek TA, Jarbadan NR, Davis C, Caldwell J. Nociceptin is present in synovial fluid of patients undergoing total knee arthroplasty. J Orthop Surg Res. 2020 Jul 16;15(1):266. doi: 10.1186/s13018-020-01789-1.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2014
Completamento primario (Effettivo)
1 settembre 2015
Completamento dello studio (Effettivo)
1 settembre 2015
Date di iscrizione allo studio
Primo inviato
5 luglio 2015
Primo inviato che soddisfa i criteri di controllo qualità
18 agosto 2015
Primo Inserito (Stima)
19 agosto 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
18 marzo 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 marzo 2016
Ultimo verificato
1 marzo 2016
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 42679
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dolore
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University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team