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- Sperimentazione clinica NCT00519584
Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone (Ropivacaine)
Duration of Interscalene Nerve Blocks With Ropivacaine Alone, Ropivacaine Mixed With Dexamethasone, and Ropivacaine Alone Combined With Systemic Dexamethasone
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study proposes to recruit 120 patients who are undergoing open shoulder surgery. Patients will be identified preoperatively by means of the surgical schedule at each participating location. Randomization will be generated by a web-based system and stratified by hospital. The attending physician will be blinded to the contents of the supplied syringes. Treatment assignments consist of three groups:
- Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block;
- Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
- bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
- bupivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
All solutions for interscalene block will contain epinephrine 1:400,000 as a marker for intravascular injection. Insulated needles with nerve stimulation will be used. Motor response in the surgical limb at a current of < 0.4 mA at 0.1 msec duration will be considered evidence of adequate needle position.
Patients will be evaluated at 5-minute intervals for 15 minutes for development of sensory and motor block. Sensory block will be assessed by loss of sensation to pinprick over the deltoid muscle. Motor block will be assessed by evaluation of ability to abduct the shoulder, the so-called "deltoid sign". During surgery, patients will receive either general anesthesia or sedation at the discretion of the attending anesthesiologist.
Demographic variables, morphometric measurements, and the specific type of procedure will be recorded. The intraoperative management strategy (i.e. general anesthesia versus sedation) and the total doses of fentanyl, midazolam, morphine, and propofol administered perioperatively will be recorded. Finger-stick blood glucose will be measured upon arrival in the postanesthesia care unit (PACU). The primary outcome will be the duration of the interscalene nerve block, which will be measured by time from onset of sensory block until first administration of analgesic medication.
The severity of postoperative pain will be assessed by a blinded observer using a verbal response score (VRS) at 10-minute intervals for 30 minutes in the PACU. Patients reporting pain scores greater than 2 will be given intravenous morphine (1-2 mg) every 5 minutes until they are comfortable. After discharge from the PACU pain unrelieved by oral medication (VRS persistently greater than 4) will be treated with intravenous morphine. Outpatients will receive a prescription for oral acetaminophen with oxycodone.
A blinded observer will interview patients each morning for three days postoperatively. Data collected will include time of block duration,the primary outcome; defined as time from onset of sensory blockade to first administration of supplemental analgesic medication after PACU discharge, as well as secondary outcomes: time to a significant increase in shoulder discomfort, time to a noticeable decrease in numbness and/or weakness, maximum VRS with rest and movement, and total opioid consumption.
The times and VRS scores for secondary outcomes will be based on patient reporting of the corresponding events daily. A member of the study staff will contact patients at 14 days postoperatively to assess for any late or persistent complications such as residual sensory or motor block.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Ohio
-
Cleveland, Ohio, Stati Uniti, 44112
- Cleveland Clinic Hillcrest
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Euclid, Ohio, Stati Uniti, 44119
- Cleveland Clinic /Euclid Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients undergoing open shoulder procedures such as rotator cuff repair, capsular shift, subacromial decompression
- Age between 18 and 70 years
Exclusion Criteria:
- Contradictions for interscalene block
- Coagulopathy
- Infection at the needle insertion site
- Moderate to severe chronic obstructive pulmonary disease (COPD)
- Contralateral pneumothorax of diaphragmatic paralysis
- Pregnancy
- Preexisting neuropathy involving the surgical limb
- Systemic glucocorticoid treatment within the last six months of surgery
- Routine opioid use
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: Ropivacaine/saline
Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
|
30 ml 0.5%
0.9% saline; systemic and local
Altri nomi:
|
Comparatore attivo: Ropivacaine/dex
Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;
|
30 ml 0.5%
8 mg (2 ml)
Altri nomi:
|
Comparatore attivo: bupivacaine/dex
bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.
|
8 mg (2 ml)
Altri nomi:
30 ml 0.5%
|
Comparatore placebo: bupivacaine/Saline
bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block
|
0.9% saline; systemic and local
Altri nomi:
30 ml 0.5%
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
the Duration of Analgesia
Lasso di tempo: surgical date to postoperative day 1 (pod 0 -1 day)
|
the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain
|
surgical date to postoperative day 1 (pod 0 -1 day)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Time to a Significant Increase in Shoulder Discomfort
Lasso di tempo: during postoperative day 1 to 3
|
the length of time until the patients' first report of surgical site pain.
|
during postoperative day 1 to 3
|
Maximum VRS Pain Scores at Rest
Lasso di tempo: postoperative day 1 day 2, day 3.
|
Verbal rating scales (VRS): a list of adjectives describing different levels of pain intensity with 0 = no pian and 10 = extremely intense pain.
An adequate VRS of pain intensity should include adjectives that reflect the extremes of this dimension; from 'no pain' to 'extremely intense pain'.
Patients are asked to read over the list of adjectives and select the word or phrase that best describes their level of pain on the scale from 0 to 10.
|
postoperative day 1 day 2, day 3.
|
Total Opioid Consumption
Lasso di tempo: during first 3 days after surgery
|
cumulative opioid consumption in oral oxycodone equivalents (mg) during the first 3 days after surgery.
|
during first 3 days after surgery
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Daniel I Sessler, MD, The Cleveland Clinic
- Investigatore principale: Kenneth Cummings III, M.D., Cleveland Clinic/Hillcrest
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 07-459
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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 .
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