Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

NCT01700491 | Terminated Phase 3

• 1 other identifier: B2012:038
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypotension

Keywords

Paravertebral Catheter; Epidural Catheter; Analgesia; Hypotension; Analgesia,Epidural; Analgesia,Paravertebral

Outcome Measures

Primary Outcomes (1)

• Analgesic Effect

  Total cumulative dose of morphine equivalent narcotics.

  At postoperative day 5

Secondary Outcomes (1)

• Hypotension

  At postoperative day 5

Study Arms (2)

Epidural Catheter 0.2% ropivacaine

ACTIVE COMPARATOR

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

Paravertebral Catheter 0.4% ropivacaine

ACTIVE COMPARATOR

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

Interventions

Epidural Catheter 0.2% ropivacaine DRUG

0.2% ropivacaine into epidural space and saline into paravertebral space

Epidural Catheter 0.2% ropivacaine

Paravertebral Catheter 0.4% ropivacaine DRUG

0.4% ropivacaine into paravertebral space and saline into the epidural space

Paravertebral Catheter 0.4% ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (2)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

MeSH Terms

Conditions

Hypotension; Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C)

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Stephen Kowalski, MD, FRCP

  University of Manitoba

  STUDY CHAIR

• Rob Brown, MD, FRCP

  University of Manitoba

  STUDY DIRECTOR

• Purnima Rao, MD

  University of Manitoba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor- Department of Thoracic Surgery

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 4, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

CA (2)