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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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.

Canada1 site
  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

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:

  1. Postoperative pain levels
  2. 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.

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 groups in NCT01522066
Study groupRoleWhat they receive
Perineural catheterExperimentalLocal anesthetic will be delivered through an indwelling perineural catheter
Receives: Procedure: Perineural catheter
Single-shot blockActive comparatorLocal 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.

  1. 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)
  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.

  1. First posted31 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2016
  4. Study completionJan 2016

Why it stopped: PI no longer at institution

Resources

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)
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

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.

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