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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55455
- University of Minnesota
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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;
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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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Experimenteel: 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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
total Maximal Pain scored via NRS 0-10 scale
Tijdsspanne: on postoperative day 1 through postoperative day 5
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maximal pain scored via NRS 0-10 scale assessed by independent assessor
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on postoperative day 1 through postoperative day 5
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Maximal Pain scored via NRS 0-10 scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: on postoperative day 5
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 5
|
|
Nausea/vomiting
Tijdsspanne: 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
Tijdsspanne: 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.
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when the patient meets discharge criteria or is discharged home, expected length of stay 10 days
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1203M11482
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