Local AnesthesiaNCT01522066
Catheter-over Needle: Outpatient Study
A study testing Perineural catheter and Single-shot block in people with Local Anesthesia and Analgesia, run by University of Alberta at 1 site in Canada.
Trial summary
An alternative to general anesthesia - which puts a patient completely to sleep - is regional anesthesia, where local anesthetic is injected under the skin to freeze or 'block' a nerve or set of nerves. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Local Anesthesia, Analgesia
- What is being tested?
- Perineural catheter and Single-shot block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jan 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (> 18 yrs)
- Scheduled for surgery that requires peripheral nerve blockade
Who cannot join
- Failure to provide informed consent
- Allergy to local anesthetic
- Neurological pathology and/or deficit in the block region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Single-shot Local Anesthetic Delivery Versus Double-shot Local Anesthetic Delivery Via a Perineural Catheter
An alternative to general anesthesia - which puts a patient completely to sleep - is regional anesthesia, where local anesthetic is injected under the skin to freeze or 'block' a nerve or set of nerves. This method allows a patient to be awake during surgery and avoids any unpleasant after-effects of general anesthetic. A regional block is normally performed by inserting a needle under the skin so that the needle tip is near the nerve to be blocked, followed by injection of a single shot of enough local anesthetic to block any sensation that the nerve normally provides. Although regional nerve blocks provide pain relief during a surgical procedure, they eventually wear off, occasionally leaving the patient to contend with localized pain in the part of the body that was operated on. In these cases, over-the-counter painkillers like Tylenol or Advil may not be strong enough to completely take away the pain. We believe that, instead of giving a single shot of anesthetic, patients can be fitted with a catheter - a thin, flexible tube - that can be used to deliver one dose of local anesthetic to block the nerve before surgery and which could also be used to deliver a second dose of anesthetic just prior to discharge from the hospital. This way, the patient still only receives one needle poke, but their pain can be better managed following surgery. Our study will compare the post-nerve block pain profiles of individuals who have received a single-shot injection of local anesthetic versus those who have received two doses via the catheter delivery method.
Read the detailed description
Background: Local anesthetic (LA) may be delivered by a single injection or by continuous infusion through an indwelling catheter. A downside of the single-shot technique is that the LA has a limited duration of action, meaning that, after discharge, patients sometimes have to contend with post-surgical pain that limits their activities and reduces their quality of life. Occasionally, a supplementary dose of analgesic, such as morphine or a LA, will be administered, either intravenously or via single injection. We speculate that, rather than using a single injection, post-operative pain management may be better controlled by installing a perineural catheter pre- or intra-operatively, which would allow a flexible schedule of LA delivery post-operatively and enable clinicians to tailor an analgesia regimen to the patient's needs. Our aim is to compare the effectiveness of a double-shot anesthetic infusion - one to block the nerve and another to provide postoperative analgesia - to the conventional single-shot method in controlling pain following a regional nerve block.
Study objective: To assess the value of a catheter-delivered supplementary infusion of LA to control postoperative pain after a regional block.
Hypothesis: Patients who have received a regional nerve block will experience less post-surgical pain when a second shot of LA is delivered through a perineural indwelling catheter just prior to discharge.
Study procedures: We will recruit patients who are scheduled to undergo surgery that requires a regional block of the upper extremity. We anticipate recruiting thirty individuals; the control group will receive one dose of LA using the conventional single-shot method, and the study group will be fitted with a perineural catheter through which one dose of LA will be delivered prior to surgery and another just before discharge from the hospital.
On the day of surgery, participating patients will be taken to the regional block area. Control group patients will be given a single injection of LA, under ultrasound guidance, to block the appropriate target nerve(s). These patients will undergo surgery and post-anesthesia recovery as per standard procedures. For patients in the experimental group, the attending anesthesiologist will, under ultrasound guidance, insert a perineural catheter at an appropriate location to block the target nerve. Once the catheter is in place, a single dose of LA will be delivered to block the target nerve, and the catheter will remain in the patient throughout the procedure. In the post-anesthesia recovery area, patients with a catheter will receive a second bolus infusion of the same LA. When the patient is approved for discharge, the catheter will be removed, the insertion site cleaned, and the patient will be allowed to go home.
A research assistant ask patients to rate their pain using a 0-10 numerical rating scale: 1) prior to delivery of the first dose of LA, 2) immediately following surgery (just before the second anesthetic infusion for experimental group patients), and 3) immediately before discharge from the hospital (after the second anesthetic infusion for experimental group patients). On the day after surgery, the research assistant will contact patients in both groups and will ask them to rate their pain over the 24-hour post-operative period. Pain reporting at these four time points will provide us with a comprehensive assessment of patient comfort after their regional nerve block and whether the second infusion of LA was effective at alleviating post-operative pain.
Primary outcomes:
- Postoperative pain levels
- Patient comfort at home
Inclusion criteria: Adult; scheduled for surgery that requires peripheral nerve blockade.
Exclusion criteria: Failure to provide informed consent; allergy to LA; neurological pathology and/or deficit in the block region.
- Conditions
- Local Anesthesia, Analgesia
- Being tested
- Perineural catheter, Single-shot block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineural catheterProcedure or surgery
Patients in the experimental group will receive a single dose of local anesthetic though an indwelling catheter both before and after surgery.
Single-shot blockProcedure or surgery
Patients in the control group will receive a single shot of local anesthetic, in standard fashion, before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Perineural catheter | Experimental | Local anesthetic will be delivered through an indwelling perineural catheter Receives: Procedure: Perineural catheter |
| Single-shot block | Active comparator | Local anesthetic will be delivered by the conventional, single-shot method. Receives: Procedure: Single-shot block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain levels
Pain levels at surgery site following surgery (up to 24 hours post-surgery) will be assessed.
Measured: 24 hours following surgery
Secondary outcomes (1)
Patient comfort at home
Patient pain levels and effects on daily living/activities will be assessed following surgery.
Measured: Post-operative period (approx. 24 hrs following surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: PI no longer at institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Local AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ban Tsui, MD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522066
- Sponsor's protocol ID
- Pro000027421
- Status last verified
- Mar 2020
- First submitted
- 26 Jan 2012
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Ip VH, Tsui BC. The catheter-over-needle assembly facilitates delivery of a second local anesthetic bolus to prolong supraclavicular brachial plexus block without time-consuming catheterization steps: a randomized controlled study. Can J Anaesth. 2013 Jul;60(7):692-9. doi: 10.1007/s12630-013-9951-5. Epub 2013 May 1.
PubMed 23637033
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Single-shot Local Anesthetic Delivery Versus Double-shot Local Anesthetic Delivery Via a Perineural Catheter
- ClinicalTrials.gov ID
- NCT01522066
- Acronym / sponsor ID
- Pro000027421
- Conditions
- Local Anesthesia, Analgesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI no longer at institution
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Jan 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.
An alternative to general anesthesia - which puts a patient completely to sleep - is regional anesthesia, where local anesthetic is injected under the skin to freeze or 'block' a nerve or set of nerves. This method allows a patient to be awake during surgery and avoids any unpleasant after-effects of general anesthetic. A regional block is normally performed by inserting a needle under the skin so that the needle tip is near the nerve to be blocked, followed by injection of a single shot of enough local anesthetic to block any sensation that the nerve normally provides. Although regional nerve blocks provide pain relief during a surgical procedure, they eventually wear off, occasionally leaving the patient to contend with localized pain in the part of the body that was operated on. In these cases, over-the-counter painkillers like Tylenol or Advil may not be strong enough to completely take away the pain. We believe that, instead of giving a single shot of anesthetic, patients can be fitted with a catheter - a thin, flexible tube - that can be used to deliver one dose of local anesthetic to block the nerve before surgery and which could also be used to deliver a second dose of anesthetic just prior to discharge from the hospital. This way, the patient still only receives one needle poke, but their pain can be better managed following surgery. Our study will compare the post-nerve block pain profiles of individuals who have received a single-shot injection of local anesthetic versus those who have received two doses via the catheter delivery method.
Detailed description
Background: Local anesthetic (LA) may be delivered by a single injection or by continuous infusion through an indwelling catheter. A downside of the single-shot technique is that the LA has a limited duration of action, meaning that, after discharge, patients sometimes have to contend with post-surgical pain that limits their activities and reduces their quality of life. Occasionally, a supplementary dose of analgesic, such as morphine or a LA, will be administered, either intravenously or via single injection. We speculate that, rather than using a single injection, post-operative pain management may be better controlled by installing a perineural catheter pre- or intra-operatively, which would allow a flexible schedule of LA delivery post-operatively and enable clinicians to tailor an analgesia regimen to the patient's needs. Our aim is to compare the effectiveness of a double-shot anesthetic infusion - one to block the nerve and another to provide postoperative analgesia - to the conventional single-shot method in controlling pain following a regional nerve block.
Study objective: To assess the value of a catheter-delivered supplementary infusion of LA to control postoperative pain after a regional block.
Hypothesis: Patients who have received a regional nerve block will experience less post-surgical pain when a second shot of LA is delivered through a perineural indwelling catheter just prior to discharge.
Study procedures: We will recruit patients who are scheduled to undergo surgery that requires a regional block of the upper extremity. We anticipate recruiting thirty individuals; the control group will receive one dose of LA using the conventional single-shot method, and the study group will be fitted with a perineural catheter through which one dose of LA will be delivered prior to surgery and another just before discharge from the hospital.
On the day of surgery, participating patients will be taken to the regional block area. Control group patients will be given a single injection of LA, under ultrasound guidance, to block the appropriate target nerve(s). These patients will undergo surgery and post-anesthesia recovery as per standard procedures. For patients in the experimental group, the attending anesthesiologist will, under ultrasound guidance, insert a perineural catheter at an appropriate location to block the target nerve. Once the catheter is in place, a single dose of LA will be delivered to block the target nerve, and the catheter will remain in the patient throughout the procedure. In the post-anesthesia recovery area, patients with a catheter will receive a second bolus infusion of the same LA. When the patient is approved for discharge, the catheter will be removed, the insertion site cleaned, and the patient will be allowed to go home.
A research assistant ask patients to rate their pain using a 0-10 numerical rating scale: 1) prior to delivery of the first dose of LA, 2) immediately following surgery (just before the second anesthetic infusion for experimental group patients), and 3) immediately before discharge from the hospital (after the second anesthetic infusion for experimental group patients). On the day after surgery, the research assistant will contact patients in both groups and will ask them to rate their pain over the 24-hour post-operative period. Pain reporting at these four time points will provide us with a comprehensive assessment of patient comfort after their regional nerve block and whether the second infusion of LA was effective at alleviating post-operative pain.
Primary outcomes:
- Postoperative pain levels
- Patient comfort at home
Inclusion criteria: Adult; scheduled for surgery that requires peripheral nerve blockade.
Exclusion criteria: Failure to provide informed consent; allergy to LA; neurological pathology and/or deficit in the block region.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineural catheter | Experimental | Procedure: Perineural catheterLocal anesthetic will be delivered through an indwelling perineural catheter |
| Single-shot block | Active comparator | Procedure: Single-shot blockLocal anesthetic will be delivered by the conventional, single-shot method. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (> 18 yrs)
- Scheduled for surgery that requires peripheral nerve blockade
Key exclusion criteria (3 listed)
- Failure to provide informed consent
- Allergy to local anesthetic
- Neurological pathology and/or deficit in the block region
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 |
|---|---|---|
| Perineural catheterPatients in the experimental group will receive a single dose of local anesthetic though an indwelling catheter both before and after surgery. | Procedure or surgery | Perineural catheter |
| Single-shot blockPatients in the control group will receive a single shot of local anesthetic, in standard fashion, before surgery. | Procedure or surgery | Single-shot block |
Primary outcome
Postoperative pain levels
Time frame: 24 hours following surgery
Pain levels at surgery site following surgery (up to 24 hours post-surgery) will be assessed.
1 secondary outcome
Patient comfort at home
Time frame: Post-operative period (approx. 24 hrs following surgery)
Results and safety
The study was stopped early (reason given: PI no longer at institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 23637033Ip VH, Tsui BC. The catheter-over-needle assembly facilitates delivery of a second local anesthetic bolus to prolong supraclavicular brachial plexus block without time-consuming catheterization steps: a randomized controlled study. Can J Anaesth. 2013 Jul;60(7):692-9. doi: 10.1007/s12630-013-9951-5. Epub 2013 May 1.
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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.
Ban Tsui, MD, MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineural catheter and Single-shot block in people with Local Anesthesia and Analgesia, run by University of Alberta 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 2 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: stopped early, as of the sponsor's last update on 25 Mar 2020. 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.
Are results available for this study?
The study was stopped early (reason given: PI no longer at institution). 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?
Postoperative pain levels (time frame: 24 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522066, which also lists 1 linked publication.
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 25 Mar 2020.