Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

Phase 3

Terminated

• Conditions: Hypotension
• Interventions: Drug: Epidural Catheter 0.2% ropivacaine; Drug: Paravertebral Catheter 0.4% ropivacaine

• Registration Number: NCT01700491
• Lead Sponsor: University of Manitoba

Brief Summary

Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior to epidural analgesia in terms of the main complication of hypotension.

Detailed Description

There is some evidence that paravertebral analgesia is similar to epidural analgesia in efficacy but superior in maintenance of blood pressure. This is a double blind, randomized control trial comparing paravertebral catheters to epidural catheters for the management of post thoracotomy analgesia. Both groups will undergo placement of a pre-induction epidural catheter as well as a surgically placed paravertebral catheter. Patients will also receive PCA morphine. The primary outcome will be daily morphine use measured in milligrams. The co-primary outcome will be time spent with a systolic blood pressure below 90mmHg. Outcomes will be measured during the first five postoperative days.

Study Timeline

• Study First Submitted: 2012-09-27
• Study Start: 2012-10
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-04
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-11
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Open thoracotomy
• Age > 18 yo
• Able to use a patient controlled analgesia device

Exclusion Criteria

• Previous thoracotomy
• Previous spine surgery
• Chronic pain condition
• Ongoing narcotic use
• Prior narcotic abuse
• Active chest infection
• Chest trauma
• Anticoagulation
• Other contraindication to epidural catheter placement
• Allergy to local anesthetic or narcotic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epidural Catheter 0.2% ropivacaine	Epidural Catheter 0.2% ropivacaine	Patients will receive an infusion of 0.2% ropivacaine at a range of 0-10 mL/hr through an epidural catheter. They will also receive an infusion of saline at a rate of 0-10 mL/hr through a paravertebral catheter.
Paravertebral Catheter 0.4% ropivacaine	Paravertebral Catheter 0.4% ropivacaine	Patients will receive an infusion of 0.4% ropivacaine at a range of 0-10mL/hr through a paravertebral catheter. They will also receive an infusion of saline at a range of 0-10mL/hr through an epidural catheter.

Primary Outcome Measures

Name	Time	Method
Analgesic Effect	At postoperative day 5	Total cumulative dose of morphine equivalent narcotics.

Secondary Outcome Measures

Name	Time	Method
Hypotension	At postoperative day 5	Cumulative time in which the systolic blood pressure is below 90mmHg.

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada