PainNCT01385449
Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks
A study testing interscalene catheter and interscalene block in people with Pain, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The primary hypothesis is that those patients who choose an interscalene catheter will have less pain postoperatively than those with single injection blocks. Secondary hypotheses examine physical therapy outcomes and incidence of parasthesia or pain following surgery for up to 3 months. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pain
- What is being tested?
- interscalene catheter and interscalene block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Feb 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1-3
- 18-79 years of age, inclusive
- body mass index of < 36 kg/m2.
- The ability to understand local anesthetic related complications and care of a CPNB
- Presence of a caretaker with them during the first 24 hours of local anesthetic infusion, and on a daily basis.
- The ability to communicate with the practitioner managing the catheter.
- Residence within 2 hours of University of Wisconsin Hospital and Clinics
Who cannot join
- Any contraindication to a continuous interscalene catheter placement
- Clinically significant pulmonary disease
- Clinically significant cardiac disease
- Allergy to ropivacaine
- Peripheral or central nervous system disease
- Current (or planned) anticoagulation therapy or disease
Show all 12Show fewer
- Local infection over area of catheter placement
- Renal or hepatic failure
- History of opioid dependence
- Significant psychiatric disease
- Pregnancy or lactation (Subjects will be asked if it is possible they could be pregnant. If a subject responds in the affirmative, a pregnancy test will be done.)
- Seizure Disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
U of Wisconsin
Madison, Wisconsin, 53705
University of Wisconsin
Madison, Wisconsin, 53705
About this study
Official title: Continuous Interscalene Block (CISB) Versus Single Injection Interscalene Block in Those Undergoing Shoulder Surgery in the Ambulatory Setting
The primary hypothesis is that those patients who choose an interscalene catheter will have less pain postoperatively than those with single injection blocks. Secondary hypotheses examine physical therapy outcomes and incidence of parasthesia or pain following surgery for up to 3 months.
- Conditions
- Pain
- Being tested
- interscalene catheter, interscalene block
- Keywords
- nerve block, shoulder surgery, physical therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene catheterProcedure or surgery
interscalene catheter
interscalene blockProcedure or surgery
interscalene block
| Study group | Role | What they receive |
|---|---|---|
| interscalene block | Experimental | interscalene block Receives: Procedure: interscalene block |
| interscalene catheter | Experimental | interscalene catheter Receives: Procedure: interscalene catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain on post-operative day 1
Pain score on post-operative day 1(POD1) using numeric rating scale (NRS)
Measured: 24 hours
Secondary outcomes (1)
Pain post operative day 2 (POD2)
NRS score on POD2
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: The study was halted prematurely due to low enrollment and anticipation of future barriers to enrollment.
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 Wisconsin, MadisonThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385449
- Sponsor's protocol ID
- H-2010-0098
- Status last verified
- Feb 2019
- First submitted
- 28 Jun 2011
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Interscalene Block (CISB) Versus Single Injection Interscalene Block in Those Undergoing Shoulder Surgery in the Ambulatory Setting
- ClinicalTrials.gov ID
- NCT01385449
- Acronym / sponsor ID
- H-2010-0098
- Conditions
- Pain
- Keywords
- nerve block, shoulder surgery, physical therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted prematurely due to low enrollment and anticipation of future barriers to enrollment.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Jun 2011 (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.
The primary hypothesis is that those patients who choose an interscalene catheter will have less pain postoperatively than those with single injection blocks. Secondary hypotheses examine physical therapy outcomes and incidence of parasthesia or pain following surgery for up to 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interscalene block | Experimental | Procedure: interscalene blockinterscalene block |
| interscalene catheter | Experimental | Procedure: interscalene catheterinterscalene catheter |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- American Society of Anesthesiologists (ASA) physical status 1-3
- 18-79 years of age, inclusive
- body mass index of < 36 kg/m2.
- The ability to understand local anesthetic related complications and care of a CPNB
- Presence of a caretaker with them during the first 24 hours of local anesthetic infusion, and on a daily basis.
Key exclusion criteria (12 listed)
- Any contraindication to a continuous interscalene catheter placement
- Clinically significant pulmonary disease
- Clinically significant cardiac disease
- Allergy to ropivacaine
- Peripheral or central nervous system disease
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 |
|---|---|---|
| interscalene catheterinterscalene catheter | Procedure or surgery | interscalene catheter |
| interscalene blockinterscalene block | Procedure or surgery | interscalene block |
Primary outcome
pain on post-operative day 1
Time frame: 24 hours
Pain score on post-operative day 1(POD1) using numeric rating scale (NRS)
1 secondary outcome
Pain post operative day 2 (POD2)
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: The study was halted prematurely due to low enrollment and anticipation of future barriers to enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interscalene catheter and interscalene block in people with Pain, run by University of Wisconsin, Madison at 2 sites 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 7 inclusion and 12 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: The study was halted prematurely due to low enrollment and anticipation of future barriers to enrollment.). 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?
pain on post-operative day 1 (time frame: 24 hours). 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 18 Feb 2019.