Paravertebral Catheters for Pancreatic Surgery

Acute Pain Clinical Trial

Official title:

Ultrasound Guided Bilateral Paravertebral Catheters Versus Thoracic Epidural Analgesia for Post- Operative Pain Control in Open Pancreatic Surgery: A Prospective Outcomes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363777
• Other study ID #: 1203M11482
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: August 30, 2017
• Start date: August 2012
• Est. completion date: June 2016

Study information

• Verified date: August 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Acute Pain

Intervention

Procedure:
• Epidural
A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively
• Paravertebral catheters
Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 1
Secondary	Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 2
Secondary	Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 3
Secondary	Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 4
Secondary	Maximal Pain scored via NRS 0-10 scale	maximal pain scored via NRS 0-10 scale assessed by independent assessor	on postoperative day 5
Secondary	Nausea/vomiting	the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor	the first five days postoperatively
Secondary	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