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.
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
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 :
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Insertion of interscalene catheter for shoulder surgery |
| 2 | Active comparator | Not 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.
Sensory block assessment
Measured: 24 hours after surgery
Secondary outcomes (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.
- First posted17 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Geneviève Arcand, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Insertion Distance on Loss of Sensation Produced by Interscalene Perineural Catheters in the Context of Shoulder Surgery.
- ClinicalTrials.gov ID
- NCT00754026
- Acronym / sponsor ID
- 08.072
- Conditions
- Pain
- Keywords
- Shoulder surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Sep 2008 (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 designed to compare interscalene catheter insertion distances, in order to determine which is the best for pain relief after shoulder surgery.
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 :
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Insertion of interscalene catheter for shoulder surgery |
| 2 | Active comparator | Procedure: Insertion of interscalene catheter for shoulder surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years and older undergoing elective shoulder surgery
Key exclusion criteria (6 listed)
- Severe COPD
- Coagulopathy
- Allergy to local anesthetics
- Chronic use of opioids
- Peripheral neuropathy of the operated limb
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 |
|---|---|---|
| Insertion of interscalene catheter for shoulder surgeryDistance of interscalene catheter: 2cm | Procedure or surgery | 1 |
| Insertion of interscalene catheter for shoulder surgeryDistance of interscalene catheter: 6cm | Procedure or surgery | 2 |
Primary outcome
Sensory block assessment
Time frame: 24 hours after surgery
1 secondary outcome
Quality of pain relief
Time frame: 24 hours after surgery
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 28 May 2010.
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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.
Geneviève Arcand, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
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.