PainNCT01122732
Comparison of Pain Relief After Non Stimulating Interscalene Catheter Placement vs Stimulating Catheter Placement in Total Shoulder Arthroplasty.
An observational study of Pain and Shoulder, run by University of Chicago at 1 site in United States.
Trial summary
1. Interscalene continuous catheter is a very effective way of controlling pain in total shoulder arthroplasty. To ensure proper placement, nerve stimulating catheter is quite often used. 2. Ultrasound can help proper placement of catheter without relying on nerve stimulation. 3. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Shoulder, Arthroplasty
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2015
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all subjects having total shoulder arthroplasty.
Who may be able to join
- 18 yr or older
- patient agreed to continuous regional block
Who cannot join
- minor
- patient refusal
- any neuropathy
- allergies to local anesthetic,
- inability to obtain informed consent for any reason, Opioid user, chronic pain patients or unanticipated procedure other than total shoulder arthroplasty
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Hospitals
Chicago, Illinois, 60637
About this study
Official title: Comparison of Pain Relief After US Guided Non Stimulating Interscalene Catheter Placement vs Stimulating Catheter Placement in Total Shoulder Arthroplasty;a Randomized Study
- Interscalene continuous catheter is a very effective way of controlling pain in total shoulder arthroplasty. To ensure proper placement, nerve stimulating catheter is quite often used.
- Ultrasound can help proper placement of catheter without relying on nerve stimulation.
- The plan of the study is to compare two techniques head to head to see if they are equally effective or one is better than others.
Read the detailed description
After consent patients will be randomized to one of the two groups: Control Group or the Experimental Group. Patients will be blinded to the group assignment. As both catheters are placed using almost the same technique, the subjects will be unable to tell type of catheter they will be getting..
Every procedure will be done after starting intravenous access and placing standard anesthesia monitors (EKG, Blood Pressure Cuff and Pulse-Ox) on the patients. For comfort care sedation will be titrated using accepted American Society of Anesthesiology and American society of Regional Anesthesia Guidelines.
In the Control Group the patient will have interscalene catheter placed using nerve stimulation technique. Initially ultrasound guidance will be used to visualize brachial plexus at the cricoid level with the intent to visualize upper trunks or roots. Then following established guidelines a nerve stimulating catheter will be placed. This will be done using an ARROW NERVE KIT. The kit is FAD approved for this purpose.. Following accepted aseptic guidelines the nerves will be visualized at the base of the neck using ultrasound machine. Once proper nerve roots or trunks visualized, kit provided 17gauge insulated Touhy needle will be used to access the brachial plexus. Once twitches elicited in Deltoid, biceps or triceps muscles at 0.5 mamp, catheter will be threaded via the needle while maintaining twitch at 0.5 mamp or less. Once catheter is threaded 3 cm beyond the tip, Touhy needle will be removed. Catheter will be tested for proper placement using lidocaine and epinephrine as is recommended by Regional Anesthesia Society guidelines. Thereafter 3 mg/kg of 0.5 % bupivacaine will be injected in small blouses via the catheter.
In the Experimental Group, after placement of monitors, the nerves will be visualized using ultrasound machine. Once nerve visualized at the cricoids level, proper tip of Touhy needle will be guided using hydro-dissection technique. Once in good place, catheter will be threaded 3 cm into the space. They subjects will be dosed using 0.5% bupivacaine 3 mg/kg for the surgery via the catheter. Adequacy of catheter placement will be judged by examining the spread of local anesthetics around the plexus.
The extent of block before the surgery will be evaluated at 30 minutes post injection. Surgery will be done with sedation. Conversion of anesthetic technique to general anesthesia will be considered failure of the technique to provide adequate surgical anesthesia.
At the end of the case the patient will be taken to recovery and will be evaluated for pain. If patient is having pain of 3 or more then they will be treated as follows.
In each catheter group patient will be dosed with 10 ml 1% lidocaine. If it fails to provide any relief then the catheter will be pulled back and another 10 ml1% lidocaine will be given. If still not effective then it will be replaced. Refusal of patient to replace the catheter will result in pt dropping out of the study.
Working catheter will be left in place for at least 48 hrs. Patients will be allowed to take oral pain medicines as prescribed by their surgeons. The patient will be sent home with pain pump to continuously give them 0.125% bupivacaine at 5 ml per hr with an option to get extra dose of 5 ml every one hr if needed. The pain control will be monitored while in-house and by phone daily till catheter comes out.
- Conditions
- Pain, Shoulder, Arthroplasty
- Keywords
- nerve block, continuous catheter, shoulder surgery, pain control after total shoulder arthroplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| US Group | Interscalene catheter will be placed with US guidance without any nerve stimulation guidance. | |
| NS Group | Catheter will be placed using nerve stimulation guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will be monitored over the next 2-3 days while subjects have catheter inplace. Sleep, total oral analgesic intake will be compared.
Measured: 2-3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2015
- Study completionSep 2015
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 University of ChicagoThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TARIQ MALIK, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122732
- Sponsor's protocol ID
- 10-242-B
- Status last verified
- Oct 2016
- First submitted
- 11 May 2010
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Relief After US Guided Non Stimulating Interscalene Catheter Placement vs Stimulating Catheter Placement in Total Shoulder Arthroplasty;a Randomized Study
- ClinicalTrials.gov ID
- NCT01122732
- Acronym / sponsor ID
- 10-242-B
- Conditions
- Pain, Shoulder, Arthroplasty
- Keywords
- nerve block, continuous catheter, shoulder surgery, pain control after total shoulder arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 May 2010 (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.
- Interscalene continuous catheter is a very effective way of controlling pain in total shoulder arthroplasty. To ensure proper placement, nerve stimulating catheter is quite often used.
- Ultrasound can help proper placement of catheter without relying on nerve stimulation.
- The plan of the study is to compare two techniques head to head to see if they are equally effective or one is better than others.
Detailed description
After consent patients will be randomized to one of the two groups: Control Group or the Experimental Group. Patients will be blinded to the group assignment. As both catheters are placed using almost the same technique, the subjects will be unable to tell type of catheter they will be getting..
Every procedure will be done after starting intravenous access and placing standard anesthesia monitors (EKG, Blood Pressure Cuff and Pulse-Ox) on the patients. For comfort care sedation will be titrated using accepted American Society of Anesthesiology and American society of Regional Anesthesia Guidelines.
In the Control Group the patient will have interscalene catheter placed using nerve stimulation technique. Initially ultrasound guidance will be used to visualize brachial plexus at the cricoid level with the intent to visualize upper trunks or roots. Then following established guidelines a nerve stimulating catheter will be placed. This will be done using an ARROW NERVE KIT. The kit is FAD approved for this purpose.. Following accepted aseptic guidelines the nerves will be visualized at the base of the neck using ultrasound machine. Once proper nerve roots or trunks visualized, kit provided 17gauge insulated Touhy needle will be used to access the brachial plexus. Once twitches elicited in Deltoid, biceps or triceps muscles at 0.5 mamp, catheter will be threaded via the needle while maintaining twitch at 0.5 mamp or less. Once catheter is threaded 3 cm beyond the tip, Touhy needle will be removed. Catheter will be tested for proper placement using lidocaine and epinephrine as is recommended by Regional Anesthesia Society guidelines. Thereafter 3 mg/kg of 0.5 % bupivacaine will be injected in small blouses via the catheter.
In the Experimental Group, after placement of monitors, the nerves will be visualized using ultrasound machine. Once nerve visualized at the cricoids level, proper tip of Touhy needle will be guided using hydro-dissection technique. Once in good place, catheter will be threaded 3 cm into the space. They subjects will be dosed using 0.5% bupivacaine 3 mg/kg for the surgery via the catheter. Adequacy of catheter placement will be judged by examining the spread of local anesthetics around the plexus.
The extent of block before the surgery will be evaluated at 30 minutes post injection. Surgery will be done with sedation. Conversion of anesthetic technique to general anesthesia will be considered failure of the technique to provide adequate surgical anesthesia.
At the end of the case the patient will be taken to recovery and will be evaluated for pain. If patient is having pain of 3 or more then they will be treated as follows.
In each catheter group patient will be dosed with 10 ml 1% lidocaine. If it fails to provide any relief then the catheter will be pulled back and another 10 ml1% lidocaine will be given. If still not effective then it will be replaced. Refusal of patient to replace the catheter will result in pt dropping out of the study.
Working catheter will be left in place for at least 48 hrs. Patients will be allowed to take oral pain medicines as prescribed by their surgeons. The patient will be sent home with pain pump to continuously give them 0.125% bupivacaine at 5 ml per hr with an option to get extra dose of 5 ml every one hr if needed. The pain control will be monitored while in-house and by phone daily till catheter comes out.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US Group | – | –Interscalene catheter will be placed with US guidance without any nerve stimulation guidance. |
| NS Group | – | –Catheter will be placed using nerve stimulation guidance |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all subjects having total shoulder arthroplasty.
Key inclusion criteria (2 listed)
- 18 yr or older
- patient agreed to continuous regional block
Key exclusion criteria (5 listed)
- minor
- patient refusal
- any neuropathy
- allergies to local anesthetic,
- inability to obtain informed consent for any reason, Opioid user, chronic pain patients or unanticipated procedure other than total shoulder arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain
Time frame: 2-3 days after surgery
Pain will be monitored over the next 2-3 days while subjects have catheter inplace. Sleep, total oral analgesic intake will be compared.
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 1 Nov 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.
TARIQ MALIK, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Shoulder, run by University of Chicago at 1 site in United States.
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 5 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 1 Nov 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 United States. 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?
Pain (time frame: 2-3 days 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 1 Nov 2016.