PainNCT01122745
Single Shot vs Continuous Interscalene Block for Rotator Cuff Repair
An observational study of Pain and Rotator Cuff, run by University of Chicago at 1 site in United States.
Trial summary
1. Rotator cuff have painful post surgery recovery. 2. Single shot interscalene with oral analgesics may or may not be enough 3. Continuous nerve block may be too much for the surgery 4. The idea is to compare two techniques to see if the two techniques can improve patient pain control and satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Rotator Cuff, Surgery
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2013
- 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 pateint undergoing arthroscopic rotator cuff surgrey and agreed to have regional block for pain control
Who may be able to join
- adult
- rotator cuff surgery
- agreeing to regional block for pain control
Who cannot join
- pregnancy
- neuropathy
- any allergies to local anesthetics
- any contraindication to nerve blocks
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 Single Shot Interscalene Block With Continuous Interscalene Block for Arthroscopic Rotator Cuff Shoulder Surgery: A Randomized Study
- Rotator cuff have painful post surgery recovery.
- Single shot interscalene with oral analgesics may or may not be enough
- Continuous nerve block may be too much for the surgery
- The idea is to compare two techniques to see if the two techniques can improve patient pain control and satisfaction.
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.
In the Control Group the patient will be given single shot interscalene block using ultrasound technique following established guidelines. The procedure will be done after starting intravenous access and placing standard anesthesia monitors (EKG, Blood Pressure Cuff and Pulse-Ox) on the patient. 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 3 mg/kg of 0.5 % bupivacaine will be injected in small blouses.
In the Experimental Group, after placement of monitors, the nerves will be visualized using ultrasound machine. There after a catheter will be placed. They subjects will be dosed using 0.5% bupivacaine 3 mg/kg for the surgery via the catheter.
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 single shot group will be offered to be blocked again or treated with oral narcotics.
In the 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 patient 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 q hr if needed. The pain control will be monitored by phone daily till catheter comes out.
- Conditions
- Pain, Rotator Cuff, Surgery
- Keywords
- continuous block, single shot, interscalene, rotator cuff surgery
- 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 |
|---|---|---|
| Catheter Group | Patient will have continuous interscalene block for pain relief placed preoperatively. They will go home with the portable pump. Pain score will be tracked via phone and compared with the control or single short group. | |
| Single shot group | Patient will have single shot interscalene block and will go home. Pain will be tracked using phone. Pain will be compared with the catheter group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
Patients having rotator cuff repair surgery will be randomized to either single shot or continuous catheter group. Pain score will be followed for 2 days to see which group gets better pain relief.
Measured: 2-3 days
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 completionOct 2013
- Study completionOct 2013
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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122745
- Sponsor's protocol ID
- 10-243-B
- Status last verified
- May 2014
- First submitted
- 11 May 2010
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Relief After Single Shot Interscalene Block With Continuous Interscalene Block for Arthroscopic Rotator Cuff Shoulder Surgery: A Randomized Study
- ClinicalTrials.gov ID
- NCT01122745
- Acronym / sponsor ID
- 10-243-B
- Conditions
- Pain, Rotator Cuff, Surgery
- Keywords
- continuous block, single shot, interscalene, rotator cuff surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (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.
- Rotator cuff have painful post surgery recovery.
- Single shot interscalene with oral analgesics may or may not be enough
- Continuous nerve block may be too much for the surgery
- The idea is to compare two techniques to see if the two techniques can improve patient pain control and satisfaction.
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.
In the Control Group the patient will be given single shot interscalene block using ultrasound technique following established guidelines. The procedure will be done after starting intravenous access and placing standard anesthesia monitors (EKG, Blood Pressure Cuff and Pulse-Ox) on the patient. 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 3 mg/kg of 0.5 % bupivacaine will be injected in small blouses.
In the Experimental Group, after placement of monitors, the nerves will be visualized using ultrasound machine. There after a catheter will be placed. They subjects will be dosed using 0.5% bupivacaine 3 mg/kg for the surgery via the catheter.
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 single shot group will be offered to be blocked again or treated with oral narcotics.
In the 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 patient 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 q hr if needed. The pain control will be monitored by phone daily till catheter comes out.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter Group | – | –Patient will have continuous interscalene block for pain relief placed preoperatively. They will go home with the portable pump. Pain score will be tracked via phone and compared with the control or single short group. |
| Single shot group | – | –Patient will have single shot interscalene block and will go home. Pain will be tracked using phone. Pain will be compared with the catheter group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All pateint undergoing arthroscopic rotator cuff surgrey and agreed to have regional block for pain control
Key inclusion criteria (3 listed)
- adult
- rotator cuff surgery
- agreeing to regional block for pain control
Key exclusion criteria (4 listed)
- pregnancy
- neuropathy
- any allergies to local anesthetics
- any contraindication to nerve blocks
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 relief
Time frame: 2-3 days
Patients having rotator cuff repair surgery will be randomized to either single shot or continuous catheter group. Pain score will be followed for 2 days to see which group gets better pain relief.
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 30 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rotator Cuff, 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 3 inclusion and 4 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 30 May 2014. 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 relief (time frame: 2-3 days). 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 30 May 2014.