Injury of Shoulder RegionNCT02554357
Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery
A study testing Exparel block in arthroscopic shoulder surgery and Bupivacaine block in shoulder surgery in people with Injury of Shoulder Region, run by North American Institute for Continuing Medical Education (NAICE) at 2 sites in Belgium.
Trial summary
Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Injury of Shoulder Region
- What is being tested?
- Exparel block in arthroscopic shoulder surgery and Bupivacaine block in shoulder surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBelgium
- Study dates
- Jul 2015to Mar 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dutch or English speaking adults
- 18 years or older ASA I-III physical class
- Scheduled for elective arthroscopic shoulder surgery
Who cannot join
- History of allergy to a local anesthetic
- Baseline neurological deficit
- Medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff
- Recent history (< 3 months) of drug or alcohol abuse
- Concomitant opioid therapy
- Preexisting coagulation disorder
- Infection at the injection site
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Department of Anesthesiology Ziekenhuis Oost-Limburg
Genk
Department of Anesthesiology ZOL
Genk
About this study
Official title: Quality of Analgesia After Interscalene Block With Bupivacaine and Exparel® vs. Bupivacaine Alone After Arthroscopic Shoulder Surgery
Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.
Read the detailed description
The interscalene brachial plexus block (ISBPB) is a common analgesic technique for procedures of the shoulder and upper arm.
Moreover, the incidence of rebound pain is well documented and is often of considerable discomfort to patients, who may quickly go from little or no pain to moderate-severe pain. Continuous nerve block techniques with home ambulatory catheters are currently utilized to manage postoperative pain.This study is designed to compare the level and duration of pain control of Exparel® injected after bupivacaine via stop-cock connected syringes and bupivacaine alone for ISBPB.
- Conditions
- Injury of Shoulder Region
- Being tested
- Exparel block in arthroscopic shoulder surgery, Bupivacaine block in shoulder surgery
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel block in arthroscopic shoulder surgeryDrug
Also called ISBPB with bupivacaine and Exparel
The interscalene block will be performed with ultrasound guidance and nerve stimulation.
Bupivacaine block in shoulder surgeryDrug
Also called ISBPB with bupivacaine alone
The interscalene block will be performed with ultrasound guidance and nerve stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Exparel block in arthroscopic surgery | Experimental | Evaluation of Exparel block in arthroscopic shoulder surgery. Receives: Drug: Exparel block in arthroscopic shoulder surgery |
| Bupivacaine block in shoulder surgery | Experimental | Evaluation of Bupivacaine block in shoulder surgery. Receives: Drug: Bupivacaine block in shoulder surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst pain
Measured: assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7
Satisfaction with analgesia
Measured: assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7
Secondary outcomes (5)
Onset of sensory block
Measured: onset will be measured up to 30 minutes
Duration of sensory block
Measured: duration will be measured up to 72 hours
Onset of motor block
Measured: onset will be measured up to 30 minutes
duration of motor block
Measured: duration will be measured up to 72 hours
functionality of the surgical arm
Measured: assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury of Shoulder RegionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- North American Institute for Continuing Medical Education (NAICE)
- Sponsor type
- University, hospital or other
- Collaborators
- New York School of Regional Anesthesia, Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Admir Hadzic, MD, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554357
- Sponsor's protocol ID
- NAICE-002
- Status last verified
- Sep 2016
- First submitted
- 11 Jul 2015
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.
PubMed 28157791
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Analgesia After Interscalene Block With Bupivacaine and Exparel® vs. Bupivacaine Alone After Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT02554357
- Acronym / sponsor ID
- NAICE-002
- Conditions
- Injury of Shoulder Region
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- North American Institute for Continuing Medical Education (NAICE)University, hospital or other
- Collaborators
- New York School of Regional Anesthesia, Pacira Pharmaceuticals, Inc
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Sep 2015 (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.
Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.
Detailed description
The interscalene brachial plexus block (ISBPB) is a common analgesic technique for procedures of the shoulder and upper arm.
Moreover, the incidence of rebound pain is well documented and is often of considerable discomfort to patients, who may quickly go from little or no pain to moderate-severe pain. Continuous nerve block techniques with home ambulatory catheters are currently utilized to manage postoperative pain.This study is designed to compare the level and duration of pain control of Exparel® injected after bupivacaine via stop-cock connected syringes and bupivacaine alone for ISBPB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel block in arthroscopic surgery | Experimental | Drug: Exparel block in arthroscopic shoulder surgeryEvaluation of Exparel block in arthroscopic shoulder surgery. |
| Bupivacaine block in shoulder surgery | Experimental | Drug: Bupivacaine block in shoulder surgeryEvaluation of Bupivacaine block in shoulder surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dutch or English speaking adults
- 18 years or older ASA I-III physical class
- Scheduled for elective arthroscopic shoulder surgery
Key exclusion criteria (8 listed)
- History of allergy to a local anesthetic
- Baseline neurological deficit
- Medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff
- Recent history (< 3 months) of drug or alcohol abuse
- Concomitant opioid therapy
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 |
|---|---|---|
| Exparel block in arthroscopic shoulder surgeryAlso: ISBPB with bupivacaine and ExparelThe interscalene block will be performed with ultrasound guidance and nerve stimulation. | Drug | Exparel block in arthroscopic surgery |
| Bupivacaine block in shoulder surgeryAlso: ISBPB with bupivacaine aloneThe interscalene block will be performed with ultrasound guidance and nerve stimulation. | Drug | Bupivacaine block in shoulder surgery |
Primary outcome
Worst pain
Time frame: assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7
Satisfaction with analgesia
Time frame: assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7
5 secondary outcomes
Onset of sensory block
Time frame: onset will be measured up to 30 minutes
Duration of sensory block
Time frame: duration will be measured up to 72 hours
Onset of motor block
Time frame: onset will be measured up to 30 minutes
duration of motor block
Time frame: duration will be measured up to 72 hours
functionality of the surgical arm
Time frame: assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7
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 8 Sep 2016.
- Derived from this study: PubMed 28157791Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.
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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.
Admir Hadzic, MD study director
Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exparel block in arthroscopic shoulder surgery and Bupivacaine block in shoulder surgery in people with Injury of Shoulder Region, run by North American Institute for Continuing Medical Education (NAICE) at 2 sites in Belgium.
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 8 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 8 Sep 2016. 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 Belgium. 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?
Worst pain (time frame: assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7). The study lists 2 primary outcomes in all. 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 NCT02554357, which also lists 1 linked publication.
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 8 Sep 2016.