Paravertebral Catheters for Pancreatic Surgery

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT02363777

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	Procedure: Epidural Procedure: Paravertebral catheters	N/A

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.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care Epidural placed for postoperative pain control	Procedure: Epidural A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively
Experimental: Experimental Intervention Bilateral paravertebral catheters placed for postoperative pain control	Procedure: Paravertebral catheters Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively

Arm

Intervention/Treatment

Active Comparator: Standard of Care

Epidural placed for postoperative pain control

Procedure: Epidural

A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively

Experimental: Experimental Intervention

Bilateral paravertebral catheters placed for postoperative pain control

Procedure: Paravertebral catheters

Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively

Outcome Measures

Primary Outcome Measures

total Maximal Pain scored via NRS 0-10 scale [on postoperative day 1 through postoperative day 5]
maximal pain scored via NRS 0-10 scale assessed by independent assessor

Secondary Outcome Measures

Maximal Pain scored via NRS 0-10 scale [on postoperative day 1]
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Maximal Pain scored via NRS 0-10 scale [on postoperative day 2]
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Maximal Pain scored via NRS 0-10 scale [on postoperative day 3]
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Maximal Pain scored via NRS 0-10 scale [on postoperative day 4]
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Maximal Pain scored via NRS 0-10 scale [on postoperative day 5]
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Nausea/vomiting [the first five days postoperatively]
the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor
Length of stay [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT02363777

Other Study ID Numbers:

1203M11482

First Posted:

Feb 16, 2015

Last Update Posted:

Aug 31, 2017

Last Verified:

Aug 1, 2017

Additional relevant MeSH terms:

Acute Pain

Study Results

No Results Posted as of Aug 31, 2017