Remote Controlled Analgesia on Patient Experience (R-CAPE)
Effect of Perineural Catheter Analgesia on Patient Experience After Orthopedic Surgery
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Acute postoperative pain is poorly treated. More than three-quarters of patients complain of pain, from moderate to extreme, after surgery. In orthopedic surgery, continuous nerve blocks analgesia has proved effective among in-hospital patients but single injection strategy is easier to implement in the growing outpatient setting.
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
The inclusion criteria are adults undergoing outpatient scheduled orthopedic surgery under general anesthesia with regional analgesia.
Non-inclusion criteria are patients over 80 years, documented cognitive impairment, inability to complete a self-administered questionnaire, presenting American Society of Anesthesiology (ASA) physical status 3 unsteady or 4, or spontaneously requiring analgesic perineural catheter or a single injection of local anesthetics.
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Montpellier, Francia, 34295
- Department of Anesthesiology and critical care, Lapeyronie University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male or female subject aged 18 or more, up to 80 years;
- Undergoing potentially painful scheduled orthopedic surgery under general anesthesia.
- Eligible to outpatient care;
Respecting the ambivalence clause defined below:
- no cons-indication to analgesic perineural catheter;
- not known allergy to local anesthetics;
- likely to be a candidate for continuous nerve block analgesia;
- Ability to complete a self-reported questionnaire;
- Have given written informed consent
Exclusion Criteria:
- Age less than 18 or more than 80 years;
- Pregnant or nursing women ;
- Not being affiliated to the social security scheme;
- Known allergy to local anesthetics of the amide type;
Regulatory constraints in the outpatient management of perineural catheters not respected:
- Inability of daily nursing care;
- No presence of a responsible adult at home the night of the intervention;
- Scheduled hospital stay;
- ASA physical status score (American Society of Anesthesiologists) above 3 or 3 unsteady;
- Spontaneous request for continuous nerve block or single injection;
- Topic unable to fulfill only a self-administered questionnaire (inability to read French, severe cognitive impairment);
- Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
- Topic treated with antipsychotics (neuroleptics or lithium);
- Subject has a documented chronic pain syndrome;
- Active consumer of narcotic topic;
- Topic have not signed informed consent.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Electronic pump
Continuous nerve blocks Remote-controlled perineural local anesthetics delivery
|
Remote-controlled perineural local anesthetics delivery
|
|
Nessun intervento: single injection
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient experience and satisfaction scale (EVAN-G)
Lasso di tempo: Second day after surgery
|
Description: Patient experience and satisfaction scale
|
Second day after surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient quality of recovery (QoR)
Lasso di tempo: First day after surgery
|
Description: Patient quality of recovery
|
First day after surgery
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Xavier CAPDEVILA, M.D., Ph.D., University Hospital, Montpellier
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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
- 9677
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 Chirurgia ortopedica
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinCompletatoIdoneo per Day Case SurgeryFrancia
-
Hamad Medical CorporationCompletatoSurgery cardiaco, cera ossea, nucleo, sternotomia mediana, infezione da ferita sternale profonda, infezione del sito chirurgicoQatar