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- Essai clinique NCT02363777
Paravertebral Catheters for Pancreatic Surgery
Ultrasound Guided Bilateral Paravertebral Catheters Versus Thoracic Epidural Analgesia for Post- Operative Pain Control in Open Pancreatic Surgery: A Prospective Outcomes Study
Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive bupivacaine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased pain compared to patients treated with thoracic epidural for post-operative pain.
Secondary Objectives:
- To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
- To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive buipvacanine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased total maximal pain scores compared to patients treated with thoracic epidural for post-operative pain.
Secondary Objectives:
- To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
- To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.
2. Synopsis and Medical Application:
Specific Aims:
Primary Hypothesis: Paravertebral catheters will result in improved pain control relative to thoracic epidural for post-operative pain from open pancreatic surgery.
Secondary Hypothesis: Paravertebral catheters will result in fewer hospital days and improved subjective respiratory function compared to patients in the thoracic epidural group.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- • All patients undergoing open pancreatic surgery.
Exclusion Criteria:
• Previous difficult airway or multiple previous intubations
- History of myasthenic syndrome
- Systemic infection
- Pre-existing sensory deficit
- PT >14 or PTT >40 sec
- Platelet count less than 50,000
- Creatinine > 1.5
- Allergy to local anesthetics
- Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post-operatively
- Use of a spinal or epidural anesthetic for surgery
- Daily use of opioid for more than a week or chronic pain syndrome
- Lack of patient cooperation
Contraindication to regional anesthesia
- Infection at injection site
- Inability to guarantee sterile equipment or sterile conditions for the block
- Patient refusal
- Risk of local anesthetic toxicity
- Coagulopathy or bleeding disorder
- Severe respiratory disease (where the patient depends on intercostal muscle function for ventilation);
- Ipsilateral diaphragmatic paresis;
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Standard of Care
Epidural placed for postoperative pain control
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A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively
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Expérimental: Experimental Intervention
Bilateral paravertebral catheters placed for postoperative pain control
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Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
total Maximal Pain scored via NRS 0-10 scale
Délai: on postoperative day 1 through postoperative day 5
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 1 through postoperative day 5
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Maximal Pain scored via NRS 0-10 scale
Délai: on postoperative day 1
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 1
|
Maximal Pain scored via NRS 0-10 scale
Délai: on postoperative day 2
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 2
|
Maximal Pain scored via NRS 0-10 scale
Délai: on postoperative day 3
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 3
|
Maximal Pain scored via NRS 0-10 scale
Délai: on postoperative day 4
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 4
|
Maximal Pain scored via NRS 0-10 scale
Délai: on postoperative day 5
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 5
|
Nausea/vomiting
Délai: the first five days postoperatively
|
the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor
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the first five days postoperatively
|
Length of stay
Délai: when the patient meets discharge criteria or is discharged home, expected length of stay 10 days
|
up through the time the patient is discharged , expected length of stay 10 days.
|
when the patient meets discharge criteria or is discharged home, expected length of stay 10 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1203M11482
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