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PainNCT00754026

Insertion Distance of Interscalene Perineural Catheters in the Context of Shoulder Surgery.

A study testing Insertion of interscalene catheter for shoulder surgery in people with Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to compare interscalene catheter insertion distances, in order to determine which is the best for pain relief after shoulder surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain
What is being tested?
Insertion of interscalene catheter for shoulder surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
Sep 2008to May 2010
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 years and older undergoing elective shoulder surgery

Who cannot join

  • Severe COPD
  • Coagulopathy
  • Allergy to local anesthetics
  • Chronic use of opioids
  • Peripheral neuropathy of the operated limb
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)

    Montreal, Quebec, H2L 4M1

Other trials in Canada

About this study

Official title: Influence of the Insertion Distance on Loss of Sensation Produced by Interscalene Perineural Catheters in the Context of Shoulder Surgery.

This study is designed to compare interscalene catheter insertion distances, in order to determine which is the best for pain relief after shoulder surgery.

Read the detailed description

Pain following shoulder surgery is reported as severe for 70% of patients, and is a major concern in both hospitalised and ambulatory surgery patients. Pain control is particularly important, as adequate analgesia allows rapid mobilisation of the operated shoulder and prevents complications related to immobility. Several methods have been proposed to treat this pain, the most promising being the interscalene nerve block. The injection of local anesthetics reduces sensation from the shoulder and provides better pain relief after surgery than narcotic medication. To prolong the duration of the analgesia, a catheter must be positioned next to the brachial plexus. Through this catheter, small quantities of local anesthetics can be continuously delivered for several hours after surgery, effectively relieving the worst of the pain.

To date, the continuous interscalene nerve block has been shown to improve pain relief, to reduce nausea, vomiting, pruritus and sleep disturbances after shoulder surgery. It also reduces the need for opioids.

Until recently, catheter techniques were not frequently used due to technical difficulties encountered with catheter installation and catheter displacement after surgery. Due to recent improvements in nerve and catheter localisation, catheter installation has become easier, more precise and more reliable. However, the distance at which the catheter must be advanced next to the brachial plexus in order to provide the best pain relief remains unknown. Insertion distance could influence the initial quality and distribution of the freezing, its duration, or both. Therefore, this study is designed to compare two catheter insertion distances, in order to help determine which is best for pain relief after shoulder surgery.

Methods :

  1. Insertion of the catheter : Patients will be randomly assigned to the following groups :
  • Group 1 : 2 cm insertion
  • Group 2 : 6 cm insertion The anesthesiologist will insert the interscalene catheter before the beginning of anesthesia for surgery. The usual medication will be used to make the installation of the catheter comfortable. Standard non-invasive monitoring will be used. The exact location where the catheter will be put in place will be identified using an ultrasound machine. This device will allow the anesthesiologist to identify the various anatomical structures. A specially designed needle will be inserted next to the brachial plexus and its position will be confirmed with a neurostimulator. Once the adequacy of needle position is confirmed, the anesthesiologist will introduce 2 cm (Group 1) or 6 cm (Group 2) of the catheter through the needle, and then will withdraw the needle. The catheter will be fixed in place to avoid displacement. Patients will receive standard regional or general anesthesia for this type of surgery.
  1. Post-operative analgesia :
  • All patients : patients will receive, through the interscalene catheter, a continuous infusion of bupivacaine 0,15% at the rate of 5 mL/h for at least 24 hours post-operatively After surgery, pain will be assessed using a verbal numeric pain scale. Patients will be asked to fill out a pain intensity measurement form using a 0-10 pain scale at 3, 6 and 24 hours after surgery.
  • Inpatients : along with the infusion; a Patient Controlled Analgesia pump will be provided to the patients.
  • Ambulatory patients : the infusion will be given through a disposable elastomeric pump. Along with the infusion, patients will receive oral hydromorphone to complete pain relief. Patients will receive standard post-operative instructions on the use of the pump and catheter. Telephone and pager numbers for physicians available at all time will also be provided to each patient. They will be asked to record their opioid use on a medication log for the first 24 hours post-operatively. Sensory block will be assessed in the major nerve distributions of the arm at 24 h after surgery. Ambulatory patients will be invited to return to the hospital to have this assessment performed.
  1. Follow-up

All patients will receive a phone call from the research team one week after surgery to assess their satisfaction towards the analgesia and to inquire about potential complications of the interscalene block.

Conditions
Pain
Being tested
Insertion of interscalene catheter for shoulder surgery
Keywords
Shoulder surgery
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insertion of interscalene catheter for shoulder surgeryProcedure or surgery

    Distance of interscalene catheter: 2cm

  • Insertion of interscalene catheter for shoulder surgeryProcedure or surgery

    Distance of interscalene catheter: 6cm

Study groups in NCT00754026
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Procedure: Insertion of interscalene catheter for shoulder surgery
2Active comparatorNot described
Receives: Procedure: Insertion of interscalene catheter for shoulder surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensory block assessment

    Measured: 24 hours after surgery

Secondary outcomes (1)
  1. Quality of pain relief

    Measured: 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00754026
Sponsor's protocol ID
08.072
Status last verified
May 2010
First submitted
15 Sep 2008
Last updated
28 May 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Insertion of interscalene catheter for shoulder surgery in people with Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 1 inclusion and 6 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 28 May 2010. 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 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?

Sensory block assessment (time frame: 24 hours after surgery). 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 28 May 2010.

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