Liver NeoplasmsNCT01711450
Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures
A study testing Paravertebral block in people with Liver Neoplasms, run by Richard Lindsay at 2 sites in Canada.
Trial summary
This study is aimed at assessing whether performing a paravertebral block (a type of regional pain relief) can reduce the pain and anxiety patients experience during radiological procedures on the liver. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2012to Jun 2013
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
- Subjects referred for liver/biliary interventions to the angiography department.
- Written informed consent to participate in the study. Ability to comply with the requirements of the study procedures
Who cannot join
- Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Patients will only be excluded on this basis following discussion with another interventional radiologist.
- Subjects who are uncooperative or cannot follow instructions. Mental state that may preclude completion of the study procedure or ability to obtain informed consent.
- Pregnant or nursing female subjects. Patient who are to undergo liver biopsy or routine biliary tube exchange. Patients with neurological/spinal conditions, or a BMI over 40, that would prevent safe/effective or well-targeted paravertebral blockade.
- Patient unable to tolerate the paravertebral block procedure, for example due to inability to lie prone
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Montreal General Hospital
Montreal, Quebec, H3G 1A4
About this study
Official title: Randomised Double Blind Controlled Study of the Effectiveness of Paravertebral Nerve Block in Decreasing Analgesia Requirements and Improving Patient Experience During Interventional Hepatic Procedures.
This study is aimed at assessing whether performing a paravertebral block (a type of regional pain relief) can reduce the pain and anxiety patients experience during radiological procedures on the liver.
Read the detailed description
Percutaneous procedures of the liver can be very painful and range from bliliary drain insertions to tumor ablation procedures. The study will randomize patients in two groups, one receiving a paravertebral nerve block prior to the procedure and one receiving a sham procedure in which saline will be injected in the paravertebral space. Pain scores and use of IV sedation will be monitored post procedure and both groups will be compared to assess whether paravetebral nerve blocks are effective at reducing pain in patients receiving such procedures.
- Conditions
- Liver Neoplasms
- Being tested
- Paravertebral block, Control sham procedure
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral blockProcedure or surgery
Injection of local anaesthesia into paravertebral space to provide analgesia
Control sham procedureProcedure or surgery
Injection of Normal saline into the paravertebral space
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block | Experimental | Paravertebral space will be needled and an anesthetic agent will be injected. Receives: Procedure: Paravertebral block |
| Control sham procedure | Placebo comparator | Paravertebral space will be needled, but only normal saline injected. Receives: Procedure: Control sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of intravenous sedation required during and after the procedure
Measured: 1 hour
Secondary outcomes (4)
Improvement in analogue pain scoring after the procedure
Measured: 1 hour
Procedure duration
Measured: 1 hour
Complication rate of liver procedure
Measured: 24 hours
Complication rate of paravertebral block
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2013
- Study completionJun 2013
Why it stopped: Institutional Ethics Board concern regarding sham procedure, requiring modifications that are not feasible within the man-power limitations of our institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Lindsay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Lindsay, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Richard Lindsay, MB Bch, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreLouis Boucher, MD, Study director, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711450
- Sponsor's protocol ID
- 12-263-SDR
- Status last verified
- Mar 2016
- First submitted
- 18 Oct 2012
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double Blind Controlled Study of the Effectiveness of Paravertebral Nerve Block in Decreasing Analgesia Requirements and Improving Patient Experience During Interventional Hepatic Procedures.
- ClinicalTrials.gov ID
- NCT01711450
- Acronym / sponsor ID
- 12-263-SDR
- Conditions
- Liver Neoplasms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institutional Ethics Board concern regarding sham procedure, requiring modifications that are not feasible within the man-power limitations of our institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Richard LindsayUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 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.
This study is aimed at assessing whether performing a paravertebral block (a type of regional pain relief) can reduce the pain and anxiety patients experience during radiological procedures on the liver.
Detailed description
Percutaneous procedures of the liver can be very painful and range from bliliary drain insertions to tumor ablation procedures. The study will randomize patients in two groups, one receiving a paravertebral nerve block prior to the procedure and one receiving a sham procedure in which saline will be injected in the paravertebral space. Pain scores and use of IV sedation will be monitored post procedure and both groups will be compared to assess whether paravetebral nerve blocks are effective at reducing pain in patients receiving such procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block | Experimental | Procedure: Paravertebral blockParavertebral space will be needled and an anesthetic agent will be injected. |
| Control sham procedure | Placebo comparator | Procedure: Control sham procedureParavertebral space will be needled, but only normal saline injected. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
- Subjects referred for liver/biliary interventions to the angiography department.
- Written informed consent to participate in the study. Ability to comply with the requirements of the study procedures
Key exclusion criteria (5 listed)
- Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Patients will only be excluded on this basis following discussion with another interventional radiologist.
- Subjects who are uncooperative or cannot follow instructions. Mental state that may preclude completion of the study procedure or ability to obtain informed consent.
- Pregnant or nursing female subjects. Patient who are to undergo liver biopsy or routine biliary tube exchange. Patients with neurological/spinal conditions, or a BMI over 40, that would prevent safe/effective or well-targeted paravertebral blockade.
- Patient unable to tolerate the paravertebral block procedure, for example due to inability to lie prone
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 |
|---|---|---|
| Paravertebral blockInjection of local anaesthesia into paravertebral space to provide analgesia | Procedure or surgery | Paravertebral block |
| Control sham procedureInjection of Normal saline into the paravertebral space | Procedure or surgery | Control sham procedure |
Primary outcome
Dose of intravenous sedation required during and after the procedure
Time frame: 1 hour
4 secondary outcomes
Improvement in analogue pain scoring after the procedure
Time frame: 1 hour
Procedure duration
Time frame: 1 hour
Complication rate of liver procedure
Time frame: 24 hours
Complication rate of paravertebral block
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Richard Lindsay, MB Bch principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Louis Boucher, MD study director
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral block in people with Liver Neoplasms, run by Richard Lindsay 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 5 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: withdrawn, as of the sponsor's last update on 23 Mar 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Dose of intravenous sedation required during and after the procedure (time frame: 1 hour). 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 23 Mar 2016.