Paravertebral Catheters for Pancreatic Surgery

Not Applicable

Completed

• Conditions: Acute Pain
• Interventions: Procedure: Paravertebral catheters; Procedure: Epidural

• Registration Number: NCT02363777
• Lead Sponsor: University of Minnesota

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:

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.

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-16
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• • All patients undergoing open pancreatic surgery.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Intervention	Paravertebral catheters	Bilateral paravertebral catheters placed for postoperative pain control
Standard of Care	Epidural	Epidural placed for postoperative pain control

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Nausea/vomiting	the first five days postoperatively	the presence of nausea and or vomiting endorsed by the patient as assessed by an 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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States