Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy (ParaEpi)

Pilot Study: A Non-Inferiority Trial of the Analgesic Effect of Paravertebral Analgesia to Epidural Analgesia for the Management of Post-Operative Pain After Thoracotomy

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

Study Overview

• Status: Terminated
• Conditions: Hypotension
• Intervention / Treatment: Drug: Epidural Catheter 0.2% ropivacaine; Drug: Paravertebral Catheter 0.4% ropivacaine

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre
    • Winnipeg, Manitoba, Canada, R3A1R9
      • Health Sciences Centre

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Epidural Catheter 0.2% ropivacaine; 0.2% ropivacaine into epidural space and saline into paravertebral space
Active Comparator: 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.	Drug: Paravertebral Catheter 0.4% ropivacaine; 0.4% ropivacaine into paravertebral space and saline into the epidural space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic Effect	Total cumulative dose of morphine equivalent narcotics.	At postoperative day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension	Cumulative time in which the systolic blood pressure is below 90mmHg.	At postoperative day 5

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C), University of Manitoba; Study Chair: Stephen Kowalski, MD, FRCP, University of Manitoba; Study Director: Rob Brown, MD, FRCP, University of Manitoba; Study Director: Purnima Rao, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Analgesia; Hypotension; Paravertebral Catheter; Epidural Catheter; Analgesia,Epidural; Analgesia,Paravertebral
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: B2012:038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No