Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

Hypotension Clinical Trial

— ParaEpi  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01700491
• Other study ID #: B2012:038
• Status: Terminated
• Phase: Phase 3
• First received: September 27, 2012
• Last updated: December 11, 2015
• Start date: October 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Epidural Catheter 0.2% ropivacaine
0.2% ropivacaine into epidural space and saline into paravertebral space
• Paravertebral Catheter 0.4% ropivacaine
0.4% ropivacaine into paravertebral space and saline into the epidural space

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic Effect	Total cumulative dose of morphine equivalent narcotics.	At postoperative day 5	No
Secondary	Hypotension	Cumulative time in which the systolic blood pressure is below 90mmHg.	At postoperative day 5	Yes