Trials / Terminated
TerminatedNCT01700491
Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- University of Manitoba · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Epidural Catheter 0.2% ropivacaine | 0.2% ropivacaine into epidural space and saline into paravertebral space |
| DRUG | Paravertebral Catheter 0.4% ropivacaine | 0.4% ropivacaine into paravertebral space and saline into the epidural space |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2012-10-04
- Last updated
- 2015-12-15
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT01700491. Inclusion in this directory is not an endorsement.