IschemiaEarly Phase 1NCT01608035
Sciatic Perineural Versus Stump Catheter for Below Knee Amputation
A Early Phase 1 study testing Sciatic catheter and Stump catheter in people with Ischemia and Phantom Limb Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
The goal of this study is to determine if pre-operative placement of the continuous peripheral nerve block by an anesthesiologist using ultrasound technology is more effective than a continuous peripheral nerve block placed during the surgery by a surgeon for patients undergoing a limb amputation Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Ischemia, Phantom Limb Pain, Vascular Disease
- What is being tested?
- Sciatic catheter and Stump catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Jul 2015
- Phase
- Early Phase 1
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- undergoing a below knee amputation
- 16 years of age or older
- regional anesthetic will be used as part of the surgery
Who cannot join
- pregnant
- allergic to local anesthetic or ultrasound jelly
- a contraindication to having a peripheral nerve block catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Sciatic Perineural Catheter vs Surgically Placed Sciatic Stump Catheter for Below Knee Amputations: Is There A Difference in Patient Outcomes
The goal of this study is to determine if pre-operative placement of the continuous peripheral nerve block by an anesthesiologist using ultrasound technology is more effective than a continuous peripheral nerve block placed during the surgery by a surgeon for patients undergoing a limb amputation
Read the detailed description
We wish to determine the most effective site for the continuous infusion of local anesthetic for patients undergoing amputation of a limb. The information we obtain from this study will help to decide the most effective manner to provide pain relief for patients in the future. The primary outcome of interest is post-operative pain relief as measured by the amount of pain-relieving medications (opioids) required by patients prior to discharge home. The secondary outcomes of interest will be pain-relieving medications (opioid) requirements during the operation, length of stay in the hospital, time required for mobility, and patient satisfaction- measured by a survey given while in hospital and 3 months later.
- Conditions
- Ischemia, Phantom Limb Pain, Vascular Disease, Chronic Pain
- Being tested
- Sciatic catheter, Stump catheter
- Keywords
- sciatic catheter, stump catheter, below knee amputation
- Medical subject headings
- Ischemia, Phantom Limb, Vascular Diseases, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic catheterProcedure or surgery
Also called anesthesiologist placed catheter
presurgical sciatic catheter insertion
Stump catheterProcedure or surgery
Also called surgeon placed catheter
intraoperative placed stump catheter
| Study group | Role | What they receive |
|---|---|---|
| sciatic catheter | Experimental | Not described Receives: Procedure: Sciatic catheter |
| Stump catheter | Active comparator | Not described Receives: Procedure: Stump catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
MAR records will be used to calculate opioid consumption
Measured: Post-op day 0-7
Secondary outcomes (1)
pain score
VAS will be used (0-10)
Measured: Post-op day 0-7 and at 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew N Sawka, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608035
- Sponsor's protocol ID
- H12-00693
- Status last verified
- May 2016
- First submitted
- 11 May 2012
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Sciatic Perineural Catheter vs Surgically Placed Sciatic Stump Catheter for Below Knee Amputations: Is There A Difference in Patient Outcomes
- ClinicalTrials.gov ID
- NCT01608035
- Acronym / sponsor ID
- H12-00693
- Conditions
- Ischemia, Phantom Limb Pain, Vascular Disease, Chronic Pain
- Keywords
- sciatic catheter, stump catheter, below knee amputation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 May 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.
The goal of this study is to determine if pre-operative placement of the continuous peripheral nerve block by an anesthesiologist using ultrasound technology is more effective than a continuous peripheral nerve block placed during the surgery by a surgeon for patients undergoing a limb amputation
Detailed description
We wish to determine the most effective site for the continuous infusion of local anesthetic for patients undergoing amputation of a limb. The information we obtain from this study will help to decide the most effective manner to provide pain relief for patients in the future. The primary outcome of interest is post-operative pain relief as measured by the amount of pain-relieving medications (opioids) required by patients prior to discharge home. The secondary outcomes of interest will be pain-relieving medications (opioid) requirements during the operation, length of stay in the hospital, time required for mobility, and patient satisfaction- measured by a survey given while in hospital and 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sciatic catheter | Experimental | Procedure: Sciatic catheter |
| Stump catheter | Active comparator | Procedure: Stump catheter |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing a below knee amputation
- 16 years of age or older
- regional anesthetic will be used as part of the surgery
Key exclusion criteria (3 listed)
- pregnant
- allergic to local anesthetic or ultrasound jelly
- a contraindication to having a peripheral nerve block catheter
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 |
|---|---|---|
| Sciatic catheterAlso: anesthesiologist placed catheterpresurgical sciatic catheter insertion | Procedure or surgery | sciatic catheter |
| Stump catheterAlso: surgeon placed catheterintraoperative placed stump catheter | Procedure or surgery | Stump catheter |
Primary outcome
Opioid consumption
Time frame: Post-op day 0-7
MAR records will be used to calculate opioid consumption
1 secondary outcome
pain score
Time frame: Post-op day 0-7 and at 3months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
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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.
Andrew N Sawka, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sciatic catheter and Stump catheter in people with Ischemia and Phantom Limb Pain, run by University of British Columbia at 1 site 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 3 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: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Opioid consumption (time frame: Post-op day 0-7). 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 20 May 2016.