Total Shoulder ArthroplastyPhase 4NCT01782872

Analgesia After Total Shoulder Arthroplasty

A Phase 4 study testing Interscalene Block (ISB) - 0.375% Ropivacaine + additives, Interscalene Block (ISB) - 0.2% Ropivacaine + additives and Interscalene Block (ISB) - 0.1% Ropivacaine + additives in people with Total Shoulder Arthroplasty, run by Hospital for Special Surgery, New York at 1 site in United States.

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

The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Total Shoulder Arthroplasty
What is being tested?: Interscalene Block (ISB) - 0.375% Ropivacaine + additives, Interscalene Block (ISB) - 0.2% Ropivacaine + additives and Interscalene Block (ISB) - 0.1% Ropivacaine + additives
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Oct 2012to Feb 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with osteoarthritis
Primary total shoulder arthroplasty
Age 18 to 80 years old
Planned use of general anesthesia
Planned use of a brachial plexus nerve block for postoperative analgesia
Ability to follow study protocol

Who cannot join

Patients younger than 18 years old and older than 80
Allergy or intolerance to one of the study medications
Patients with an American Society of Anesthesiologists (ASA) physical status of IV
Patients with insulin-dependent diabetes
Patients with hepatic (liver) failure
Patients with chronic renal (kidney) failure

Show all 9Show fewer

Bradycardia (heart rate < 50) or hypotension (systolic blood pressure < 90 mmHg)
Chronic opioid use (taking opioids for longer than 3 months) (or active diagnosis of complex regional pain syndrome [CRPS]/reflex sympathetic dystrophy [RSD])
Lack of English fluency

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

Read the detailed description

All patients will receive an intravenous pain pump (patient-controlled analgesia) and a nerve block with long-lasting local anesthetic. The three study groups will receive additives (clonidine, dexamethasone, buprenorphine plus local anesthetic) in the nerve block that may reduce postoperative pain. One of the study groups uses the usual concentration of local anesthetic, while the other two study groups use reduced concentrations of local anesthetic. Follow-up with study patients begins on the day of surgery and continues through postoperative day 2. Seen twice daily, patients will be asked about their pain and assessed for sensory function and strength of their shoulder muscle and hand grip.

Conditions: Total Shoulder Arthroplasty
Being tested: Interscalene Block (ISB) - 0.375% Ropivacaine + additives, Interscalene Block (ISB) - 0.2% Ropivacaine + additives, Interscalene Block (ISB) - 0.1% Ropivacaine + additives, Interscalene Block (ISB) - Systemic Control

What participants receive

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

Interscalene Block (ISB) - 0.375% Ropivacaine + additivesProcedure or surgery
Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
Interscalene Block (ISB) - 0.2% Ropivacaine + additivesProcedure or surgery
Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
Interscalene Block (ISB) - 0.1% Ropivacaine + additivesProcedure or surgery
Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
Interscalene Block (ISB) - Systemic ControlProcedure or surgery
Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)

Study groups in NCT01782872
Study group	Role	What they receive
Interscalene Block (ISB) - 0.375% Ropivacaine + additives	Active comparator	Not described Receives: Procedure: Interscalene Block (ISB) - 0.375% Ropivacaine + additives
Interscalene Block (ISB) - 0.2% Ropivacaine + additives	Active comparator	Not described Receives: Procedure: Interscalene Block (ISB) - 0.2% Ropivacaine + additives
Interscalene Block (ISB) - 0.1% Ropivacaine + additives	Active comparator	Not described Receives: Procedure: Interscalene Block (ISB) - 0.1% Ropivacaine + additives
Interscalene Block (ISB) - Systemic Control	Active comparator	Not described Receives: Procedure: Interscalene Block (ISB) - Systemic Control

What is being measured

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

Numeric Rating Scale (NRS) Pain Score With Movement
Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)
Measured: 24 hours after the interscalene block is given

Secondary outcomes (3)

Duration of Analgesia From Interscalene Nerve Block
Median time until a patient needed to take opioid pain medication
Measured: Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM
Numeric Rating Scale (NRS) Pain Scores at Rest
Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest
Measured: Preop
Middle Deltoid
A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer
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.

Oct 2012Feb 2014

First posted4 Feb 2013 (estimated)
Study startOct 2012
Primary completionJan 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Total Shoulder ArthroplastyStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01782872
Sponsor's protocol ID: 2012-014
Status last verified: Apr 2016
First submitted: 24 Sep 2012
Last updated: 18 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
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Comparison of Lateralized RTSA With and Without Subscapularis Repair
Reverse Shoulder Arthroplasty
Recruiting
INHANCE Stemless Reverse Shoulder IDE
Arthroplasty, Replacement
Enrolling by invitationObservational study
Subscapularis-Sparing Total Shoulder Arthroplasty
Total Shoulder Arthroplasty
Not yet recruiting
Assessment of Posterior Subluxation of the Humeral Head Using Biplanar Imaging in the Upright Position in Patients Scheduled for Total Shoulder Arthroplasty
Shoulder Arthroplasty

All Total Shoulder Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analgesia After Total Shoulder Arthroplasty
ClinicalTrials.gov ID: NCT01782872
Acronym / sponsor ID: 2012-014
Conditions: Total Shoulder Arthroplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: Oct 2012
Primary completion: Jan 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 4 Feb 2013 (estimated)
Results: Posted 18 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Interscalene Block (ISB) - 0.375% Ropivacaine + additives	Active comparator	Procedure: Interscalene Block (ISB) - 0.375% Ropivacaine + additives
Interscalene Block (ISB) - 0.2% Ropivacaine + additives	Active comparator	Procedure: Interscalene Block (ISB) - 0.2% Ropivacaine + additives
Interscalene Block (ISB) - 0.1% Ropivacaine + additives	Active comparator	Procedure: Interscalene Block (ISB) - 0.1% Ropivacaine + additives
Interscalene Block (ISB) - Systemic Control	Active comparator	Procedure: Interscalene Block (ISB) - Systemic Control

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients with osteoarthritis
Primary total shoulder arthroplasty
Age 18 to 80 years old
Planned use of general anesthesia
Planned use of a brachial plexus nerve block for postoperative analgesia

Key exclusion criteria (9 listed)

Patients younger than 18 years old and older than 80
Allergy or intolerance to one of the study medications
Patients with an American Society of Anesthesiologists (ASA) physical status of IV
Patients with insulin-dependent diabetes
Patients with hepatic (liver) failure

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 Block (ISB) - 0.375% Ropivacaine + additivesUltrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline	Procedure or surgery	Interscalene Block (ISB) - 0.375% Ropivacaine + additives
Interscalene Block (ISB) - 0.2% Ropivacaine + additivesUltrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline	Procedure or surgery	Interscalene Block (ISB) - 0.2% Ropivacaine + additives
Interscalene Block (ISB) - 0.1% Ropivacaine + additivesUltrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline	Procedure or surgery	Interscalene Block (ISB) - 0.1% Ropivacaine + additives
Interscalene Block (ISB) - Systemic ControlUltrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)	Procedure or surgery	Interscalene Block (ISB) - Systemic Control

Primary outcome

Numeric Rating Scale (NRS) Pain Score With Movement
Time frame: 24 hours after the interscalene block is given
Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)

3 secondary outcomes

Duration of Analgesia From Interscalene Nerve Block
Time frame: Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM
Numeric Rating Scale (NRS) Pain Scores at Rest
Time frame: Preop
Middle Deltoid
Time frame: 24 hours after surgery

Results and safety

Results posted to the registry on 18 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Dose	20	20
Medium Dose	20	19
Low Dose	20	20
Control	20	19

Primary outcome: Numeric Rating Scale (NRS) Pain Score With Movement

Time frame: 24 hours after the interscalene block is given. Mean (Standard Deviation). Unit: units on a scale

Measure	High Dose n = 20	Medium Dose n = 19	Low Dose n = 20	Control n = 19
Value	4.5 (3.0)	3.4 (1.8)	4.2 (2.4)	4.9 (2.5)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Dose	0 of 20 (0%)	0 of 20 (0%)	Not reported
Medium Dose	0 of 20 (0%)	0 of 20 (0%)	Not reported
Low Dose	0 of 20 (0%)	0 of 20 (0%)	Not reported
Control	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Total Shoulder Arthroplasty

Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Recruiting
Comparison of Lateralized RTSA With and Without Subscapularis Repair
Reverse Shoulder Arthroplasty
Recruiting
INHANCE Stemless Reverse Shoulder IDE
Arthroplasty, Replacement
Enrolling by invitationObservational study
Subscapularis-Sparing Total Shoulder Arthroplasty
Total Shoulder Arthroplasty
Not yet recruiting
Assessment of Posterior Subluxation of the Humeral Head Using Biplanar Imaging in the Upright Position in Patients Scheduled for Total Shoulder Arthroplasty
Shoulder Arthroplasty

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.

Jacques T YaDeau, MD, PhD principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 9 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 18 May 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Numeric Rating Scale (NRS) Pain Score With Movement (time frame: 24 hours after the interscalene block is given). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01782872.

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 May 2016.