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:

1. 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.
2. 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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Procedure: Epidural; Procedure: Paravertebral catheters

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:

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 1 through postoperative day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 1
Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 2
Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 3
Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 4
Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 5
Nausea/vomiting	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	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

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimate): February 16, 2015

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 1203M11482