- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01495624
The Effect of Systemic or Perineural Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine
Patients undergoing rotator cuff repair or subacromial decompression at the investigators institution are frequently hospitalized overnight due to inadequate pain relief after resolution of interscalene brachial plexus blocks. For ropivacaine 0.5%, the investigators usual local anesthetic, previous studies report an analgesic duration of 11.1 ± 5 hours without epinephrine and approximately 12 hours with epinephrine. Consequently, a method of prolonging analgesia from a brachial plexus block without the extra equipment and logistical difficulties of indwelling catheters would benefit both patients and caregivers. A potential approach is use of adjuvant drugs that prolong block duration when added to the local anesthetic.
In addition to the usual adjuvant anesthetic drugs, investigators have begun to evaluate glucocorticoids as adjuvants for regional anesthesia. Known for their anti-inflammatory, analgesic, immunosuppressive, and antiemetic properties, these corticosteroids exert their effects by inhibition of phospholipase A2 as well as changes in cell function induced by glucocorticoid receptor activation. Although associated with significant toxicity when administered in large doses for long periods, emerging literature suggests that a single perioperative dose of glucocorticoid is safe. Several studies, including a recent trial at the investigators institution, have demonstrated the efficacy of dexamethasone in prolonging regional anesthetics. Available data thus suggest that combining glucocorticoids with local anesthetics prolongs block duration. However, systemic glucocorticoids have also been shown to reduce postoperative pain. This raises the question whether the beneficial effects of adding glucocorticoid to a regional anesthetic is solely due to local effect or is mediated at least in part by systemic action. Previous trials, however, have not addressed this important issue. If this beneficial effect of analgesic duration is mediated by systemic action, adding dexamethasone to the local anesthetic mixture may be unnecessary. Although no study has reported neurotoxicity from perineural dexamethasone and laboratory data appear to confirm the safety of this route, achieving similar results with more conventional administration would be desirable for two reasons. First, conventional intravenous dosing is convenient, useful for other reasons (for example, postoperative nausea prophylaxis), and well-studied. Second, equivalent (or not equivalent) results from systemic dosing would provide valuable information about the mechanism behind dexamethasone's effect on block duration.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Foundation
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Patients undergoing shoulder procedures such as
- Rotator cuff repair
- Capsular shift
- Shoulder arthroplasty
Subacromial decompression
• Exclusion Criteria:
- Contraindications to interscalene block
- Coagulopathy
- Infection at the needle insertion site
- Moderate to severe chronic obstructive pulmonary disease (COPD)
Contralateral pneumothorax or diaphragmatic paralysis
- Pregnancy
- Preexisting neuropathy involving the surgical limb
- Systemic glucocorticoid treatment (for at least one week) within six months of surgery
- Routine opioid use (greater than 30 mg oxycodone per day or equivalent)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Ropivacaine with perineural dexamethasone
30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo);
|
Subjects will receive interscalen block comprised of 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo);
|
|
Comparatore attivo: Ropivacaine with systemic steroid
30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically.
|
Subjects will receive interscalen block with 30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
duration of interscalene nerve block
Lasso di tempo: Day one
|
The clinical duration of the interscalene nerve block, which will be measured by time from onset of sensory block until first administration of analgesic medication or requirement for initiation of the perineural catheter infusion.
|
Day one
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
increase in shoulder discomfort
Lasso di tempo: as reported in minutes after procedure, day one
|
time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.
|
as reported in minutes after procedure, day one
|
|
maximum VRS (Verbal Response Score) with rest
Lasso di tempo: upon admission to PACU through post operative day 2, post operative day 14
|
time to a noticeable increase in shoulder discomfort, maximum VRS (Verbal Response Score) with rest and movement, and total opioid consumption.
|
upon admission to PACU through post operative day 2, post operative day 14
|
|
Verbal Response Score (VRS) with movement
Lasso di tempo: upon admission daily through post operative day 2, post operative day 14
|
time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.
|
upon admission daily through post operative day 2, post operative day 14
|
|
total opioid consumption
Lasso di tempo: daily through post operative day 2
|
time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.
|
daily through post operative day 2
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Kenneth Cummings, MD, The Cleveland Clinic
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Agenti del sistema sensoriale
- Agenti antinfiammatori
- Agenti antineoplastici
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Inibitori della proteasi
- Anestetici, Locali
- Desametasone
- Desametasone acetato
- BB 1101
- Anestetici
- Ropivacaina
Altri numeri di identificazione dello studio
- 11-1048
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 .