Pain, PostoperativeNCT01362075
Pain Management After Shoulder Prosthesis: A Clinical Trial of Nerve Block and Local Infiltration
A study testing Local infiltration analgesia and Interscalene catheter in people with Pain, Postoperative, run by Horsens Hospital at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine the efficacy of local infiltration analgesia as compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The investigators hypothesize a reduced pain score and use of supplemental analgesic medication during the first three postoperative days using… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Local infiltration analgesia and Interscalene catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesDenmark
- Study dates
- Jul 2011to Oct 2014
- 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
- elective primary shoulder arthroplasty
Who cannot join
- reverse or delta prosthesis
- recent fracture near the shoulder
- allergic to amid-type local analgesics
- operation not under general anaesthesia
- incompetent, pregnant, below 18 or above 90 years old
- severe chronic neurogenic pain or sensory disturbances in the shoulder
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital, Aarhus Hospital
Aarhus, Denmark, DK-8000
Horsens Hospital
Horsens, Denmark, DK-8700
About this study
Official title: Pain Management After Shoulder Arthroplasty: A Randomised Clinical Trial of Interscalene Block and Local Infiltration Analgesia
The purpose of this study is to determine the efficacy of local infiltration analgesia as compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The investigators hypothesize a reduced pain score and use of supplemental analgesic medication during the first three postoperative days using local infiltration analgesia.
- Conditions
- Pain, Postoperative
- Being tested
- Local infiltration analgesia, Interscalene catheter
- Keywords
- Shoulder Arthroplasty, Local infiltration analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local infiltration analgesiaProcedure or surgery
Also called LIA
150 ml ropivacaine, of which 100 ml is with adrenalin
Interscalene catheterProcedure or surgery
Also called interscalene block
7 ml ropivacaine interscalene block via catheter, subsequently given 5 ml/h and possibility of 5 ml bolus for the first 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Local infiltration analgesia | Experimental | Not described Receives: Procedure: Local infiltration analgesia |
| Interscalene catheter | Active comparator | Not described Receives: Procedure: Interscalene catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supplemental analgesics ingested
Measured: First 24 hours postoperatively
Secondary outcomes (2)
Pain score
Measured: First 72 hours postoperatively
Supplemental analgesics ingested
Measured: First 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionOct 2014 (estimated)
Why it stopped: After 3 years of recruitment, the study was stopped due to time constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horsens Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital, The Hede Nielsen Family Foundation, Central Denmark Region, The Danish Rheumatism Association
- Responsible party
- Principal investigator, Karen Toftdahl Bjørnholdt, Horsens Hospital
- Investigators
- Karen T Bjørnholdt, MD, Principal investigator, Horsens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362075
- Sponsor's protocol ID
- KTB-001
- Other IDs
- M-20110084
- Status last verified
- Aug 2014
- First submitted
- 26 May 2011
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management After Shoulder Arthroplasty: A Randomised Clinical Trial of Interscalene Block and Local Infiltration Analgesia
- ClinicalTrials.gov ID
- NCT01362075
- Acronym / sponsor ID
- KTB-001
- Conditions
- Pain, Postoperative
- Keywords
- Shoulder Arthroplasty, Local infiltration analgesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After 3 years of recruitment, the study was stopped due to time constraints.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Horsens HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital, The Hede Nielsen Family Foundation, Central Denmark Region, The Danish Rheumatism Association
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (estimated)
- First posted
- 27 May 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 purpose of this study is to determine the efficacy of local infiltration analgesia as compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The investigators hypothesize a reduced pain score and use of supplemental analgesic medication during the first three postoperative days using local infiltration analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local infiltration analgesia | Experimental | Procedure: Local infiltration analgesia |
| Interscalene catheter | Active comparator | Procedure: Interscalene catheter |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective primary shoulder arthroplasty
Key exclusion criteria (6 listed)
- reverse or delta prosthesis
- recent fracture near the shoulder
- allergic to amid-type local analgesics
- operation not under general anaesthesia
- incompetent, pregnant, below 18 or above 90 years old
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 |
|---|---|---|
| Local infiltration analgesiaAlso: LIA150 ml ropivacaine, of which 100 ml is with adrenalin | Procedure or surgery | Local infiltration analgesia |
| Interscalene catheterAlso: interscalene block7 ml ropivacaine interscalene block via catheter, subsequently given 5 ml/h and possibility of 5 ml bolus for the first 48 hours. | Procedure or surgery | Interscalene catheter |
Primary outcome
Supplemental analgesics ingested
Time frame: First 24 hours postoperatively
2 secondary outcomes
Pain score
Time frame: First 72 hours postoperatively
Supplemental analgesics ingested
Time frame: First 72 hours postoperatively
Results and safety
The study was stopped early (reason given: After 3 years of recruitment, the study was stopped due to time constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 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.
Karen T Bjørnholdt, MD principal investigator
Horsens Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local infiltration analgesia and Interscalene catheter in people with Pain, Postoperative, run by Horsens Hospital at 2 sites in Denmark.
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 1 inclusion and 6 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 8 Aug 2014. 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 Denmark. 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: After 3 years of recruitment, the study was stopped due to time constraints.). 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?
Supplemental analgesics ingested (time frame: First 24 hours postoperatively). 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 8 Aug 2014.