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

University of Manitoba

Status and phase: Terminated; Phase 3

Conditions: Hypotension

Treatments: Drug: Epidural Catheter 0.2% ropivacaine; Drug: Paravertebral Catheter 0.4% ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01700491

B2012:038

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

21 participants in 2 patient groups

Epidural Catheter 0.2% ropivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: Epidural Catheter 0.2% ropivacaine

Paravertebral Catheter 0.4% ropivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: Paravertebral Catheter 0.4% ropivacaine