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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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;
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Standard of Care
Epidural placed for postoperative pain control
|
A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively
|
|
Experimentell: Experimental Intervention
Bilateral paravertebral catheters placed for postoperative pain control
|
Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
total Maximal Pain scored via NRS 0-10 scale
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximal Pain scored via NRS 0-10 scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: on postoperative day 5
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 5
|
|
Nausea/vomiting
Tidsram: the first five days postoperatively
|
the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor
|
the first five days postoperatively
|
|
Length of stay
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1203M11482
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