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Paravertebral Catheters for Pancreatic Surgery

Primary Purpose

Acute Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural
Paravertebral catheters
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Experimental Intervention

Arm Description

Epidural placed for postoperative pain control

Bilateral paravertebral catheters placed for postoperative pain control

Outcomes

Primary Outcome Measures

total Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor

Secondary Outcome Measures

Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Nausea/vomiting
the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor
Length of stay
up through the time the patient is discharged , expected length of stay 10 days.

Full Information

First Posted
February 3, 2015
Last Updated
August 30, 2017
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02363777
Brief Title
Paravertebral Catheters for Pancreatic Surgery
Official Title
Ultrasound Guided Bilateral Paravertebral Catheters Versus Thoracic Epidural Analgesia for Post- Operative Pain Control in Open Pancreatic Surgery: A Prospective Outcomes Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Epidural placed for postoperative pain control
Arm Title
Experimental Intervention
Arm Type
Experimental
Arm Description
Bilateral paravertebral catheters placed for postoperative pain control
Intervention Type
Procedure
Intervention Name(s)
Epidural
Intervention Description
A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively
Intervention Type
Procedure
Intervention Name(s)
Paravertebral catheters
Intervention Description
Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively
Primary Outcome Measure Information:
Title
total Maximal Pain scored via NRS 0-10 scale
Description
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time Frame
on postoperative day 1 through postoperative day 5
Secondary Outcome Measure Information:
Title
Maximal Pain scored via NRS 0-10 scale
Description
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time Frame
on postoperative day 1
Title
Maximal Pain scored via NRS 0-10 scale
Description
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time Frame
on postoperative day 2
Title
Maximal Pain scored via NRS 0-10 scale
Description
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time Frame
on postoperative day 3
Title
Maximal Pain scored via NRS 0-10 scale
Description
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time Frame
on postoperative day 4
Title
Maximal Pain scored via NRS 0-10 scale
Description
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time Frame
on postoperative day 5
Title
Nausea/vomiting
Description
the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor
Time Frame
the first five days postoperatively
Title
Length of stay
Description
up through the time the patient is discharged , expected length of stay 10 days.
Time Frame
when the patient meets discharge criteria or is discharged home, expected length of stay 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Paravertebral Catheters for Pancreatic Surgery

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