HypotensionPhase 3ParaEpiNCT01700491
Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy
A Phase 3 study testing Epidural Catheter 0.2% ropivacaine and Paravertebral Catheter 0.4% ropivacaine in people with Hypotension, run by University of Manitoba at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypotension
- What is being tested?
- Epidural Catheter 0.2% ropivacaine and Paravertebral Catheter 0.4% ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2012to Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Open thoracotomy
- Age > 18 yo
- Able to use a patient controlled analgesia device
Who cannot join
- Previous thoracotomy
- Previous spine surgery
- Chronic pain condition
- Ongoing narcotic use
- Prior narcotic abuse
- Active chest infection
Show all 10Show fewer
- Chest trauma
- Anticoagulation
- Other contraindication to epidural catheter placement
- Allergy to local anesthetic or narcotic
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Health Sciences Centre
Winnipeg, Manitoba, R3A1R9
About this study
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
Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior to epidural analgesia in terms of the main complication of hypotension.
Read the 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
- Hypotension
- Being tested
- Epidural Catheter 0.2% ropivacaine, Paravertebral Catheter 0.4% ropivacaine
- Keywords
- Paravertebral Catheter, Epidural Catheter, Analgesia, Hypotension, Analgesia,Epidural, Analgesia,Paravertebral
- Medical subject headings
- Hypotension, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Catheter 0.2% ropivacaineDrug
0.2% ropivacaine into epidural space and saline into paravertebral space
Paravertebral Catheter 0.4% ropivacaineDrug
0.4% ropivacaine into paravertebral space and saline into the epidural space
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Paravertebral Catheter 0.4% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Effect
Total cumulative dose of morphine equivalent narcotics.
Measured: At postoperative day 5
Secondary outcomes (1)
Hypotension
Cumulative time in which the systolic blood pressure is below 90mmHg.
Measured: At postoperative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Difficulty in recruiting and maintenance of blinding necessary for the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadeesh Srinathan, MD, University of Manitoba
- Investigators
- Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C), Principal investigator, University of ManitobaStephen Kowalski, MD, FRCP, Study chair, University of ManitobaRob Brown, MD, FRCP, Study director, University of ManitobaPurnima Rao, MD, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700491
- Sponsor's protocol ID
- B2012:038
- Acronym
- ParaEpi
- Status last verified
- Dec 2015
- First submitted
- 27 Sep 2012
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01700491
- Acronym / sponsor ID
- ParaEpi / B2012:038
- Conditions
- Hypotension
- Keywords
- Paravertebral Catheter, Epidural Catheter, Analgesia, Hypotension, Analgesia,Epidural, Analgesia,Paravertebral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting and maintenance of blinding necessary for the trial
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Catheter 0.2% ropivacaine | Active comparator | Drug: Epidural Catheter 0.2% ropivacainePatients 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. |
| Paravertebral Catheter 0.4% ropivacaine | Active comparator | Drug: Paravertebral Catheter 0.4% ropivacainePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Open thoracotomy
- Age > 18 yo
- Able to use a patient controlled analgesia device
Key exclusion criteria (10 listed)
- Previous thoracotomy
- Previous spine surgery
- Chronic pain condition
- Ongoing narcotic use
- Prior narcotic abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Catheter 0.2% ropivacaine0.2% ropivacaine into epidural space and saline into paravertebral space | Drug | Epidural Catheter 0.2% ropivacaine |
| Paravertebral Catheter 0.4% ropivacaine0.4% ropivacaine into paravertebral space and saline into the epidural space | Drug | Paravertebral Catheter 0.4% ropivacaine |
Primary outcome
Analgesic Effect
Time frame: At postoperative day 5
Total cumulative dose of morphine equivalent narcotics.
1 secondary outcome
Hypotension
Time frame: At postoperative day 5
Results and safety
The study was stopped early (reason given: Difficulty in recruiting and maintenance of blinding necessary for the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C) principal investigator
University of Manitoba
Stephen Kowalski, MD, FRCP study chair
University of Manitoba
Rob Brown, MD, FRCP study director
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epidural Catheter 0.2% ropivacaine and Paravertebral Catheter 0.4% ropivacaine in people with Hypotension, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting and maintenance of blinding necessary for the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic Effect (time frame: At postoperative day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.