Clinical trial NCT02363777: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: total Maximal Pain scored via NRS 0-10 scale
timeFrame: on postoperative day 1 through postoperative day 5
Secondary outcomes:
measure: Maximal Pain scored via NRS 0-10 scale
timeFrame: on postoperative day 1
measure: Maximal Pain scored via NRS 0-10 scale
timeFrame: on postoperative day 2
measure: Maximal Pain scored via NRS 0-10 scale
timeFrame: on postoperative day 3
measure: Maximal Pain scored via NRS 0-10 scale
timeFrame: on postoperative day 4
measure: Maximal Pain scored via NRS 0-10 scale
timeFrame: on postoperative day 5
measure: Nausea/vomiting
timeFrame: the first five days postoperatively
measure: Length of stay
timeFrame: when the patient meets discharge criteria or is discharged home, expected length of stay 10 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: