Rotator Cuff TearNCT01204606
Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
A study testing Arthroscopic rotator cuff repair with intraoperative periarticular injection and Arthroscopic rotator cuff repair with non-injection of MMA drugs in people with Rotator Cuff Tear, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy of periarticular injections consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with the efficacy of periarticular injections consisting of the same amount of placebo(isotonic saline) during arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Arthroscopic rotator cuff repair with intraoperative periarticular injection and Arthroscopic rotator cuff repair with non-injection of MMA drugs
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Mar 2011
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rotator cuff tear
- arthroscopic surgery
Who cannot join
- age<45 or >85
- allergies to the drugs used in the study
- acute trauma history
- history of renal disease
- history of hepatic disease
- osteoarthritis or rheumatic arthritis
Show all 10Show fewer
- systemic condition with chronic pain
- history of infection
- could not understand the questions
- rotator cuff tear treated by the open technique, by debridement only
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Joint and Spine Center; SMG-SNU Boramae Medical Center
Seoul, 156-707
About this study
Official title: Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA): A Randomized, Double-blind, Placebo-controlled Trial
- The purpose of this study is to compare the efficacy of periarticular injections consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with the efficacy of periarticular injections consisting of the same amount of placebo(isotonic saline) during arthroscopic rotator cuff repair.
- Adding of multimodal analgesia(MMA) to conventional rotator cuff repair, it was expected that could reduce postoperative pain and narcotic consumption.
- Conditions
- Rotator Cuff Tear
- Being tested
- Arthroscopic rotator cuff repair with intraoperative periarticular injection, Arthroscopic rotator cuff repair with non-injection of MMA drugs
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff repair with intraoperative periarticular injectionProcedure or surgery
- Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
- The surgical area was prepared and draped with Betadine.
- Small stab incisions were made in the creation of 4 or 5 portals as needed.
- A scope was explored via the arthroscopic portal into the GH joint \& subacromial space.
- Repaired of rotator cuff tear was done with suture anchors.
- Mixed MMA drugs(ropivacaine 300mg;40ml, morphine 10mg;1ml, cefotetan 1g; dilution to ropivacaine, epinephrine 0.3mg;0.3ml, total volume:41.3ml) and sodium hyaluronate 20mg;2ml were injected divisionally periarticular area; intra-articular(sodium hyaluronate 20ml;2ml + 10.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml).
- The skin was closed with Nylon or medical staples.
- Sterile dressing was applied on surgical wound.
- Peripheral intravenous PCA(Patient Controlled Analgesia) was connected.
Arthroscopic rotator cuff repair with non-injection of MMA drugsProcedure or surgery
- Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
- The surgical area was prepared and draped with Betadine.
- Small stab incisions were made in the creation of 4 or 5 portals as needed.
- A scope was explored via the arthroscopic portal into the GH joint \& subacromial space.
- Repaired of rotator cuff tear was done with suture anchors.
- 43.3ml of saline was injected divisionally periarticular area; intra-articular(12.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml).
- The skin was closed with Nylon or medical staples.
- Sterile dressing was applied on surgical wound.
- Peripheral intravenous PCA(Patient Controlled Analgesia) was connected.
| Study group | Role | What they receive |
|---|---|---|
| MMA group | Experimental | Not described Receives: Procedure: Arthroscopic rotator cuff repair with intraoperative periarticular injection |
| Control group | Placebo comparator | Not described Receives: Procedure: Arthroscopic rotator cuff repair with non-injection of MMA drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale(VAS) for Pain
Measured: postoperative 5 hours
Secondary outcomes (1)
Postoperative narcotic consumption
Measured: every 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunchul Jo, Seoul National University Hospital
- Investigators
- Chris H. Jo, M.D., Ph.D, Principal investigator, Seoul Metropolitan Government Seoul National University Boramae Medical Center; Joint and Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204606
- Sponsor's protocol ID
- BRM-10-02
- Status last verified
- Mar 2013
- First submitted
- 16 Sep 2010
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA): A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01204606
- Acronym / sponsor ID
- BRM-10-02
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- First posted
- 17 Sep 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.
- The purpose of this study is to compare the efficacy of periarticular injections consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with the efficacy of periarticular injections consisting of the same amount of placebo(isotonic saline) during arthroscopic rotator cuff repair.
- Adding of multimodal analgesia(MMA) to conventional rotator cuff repair, it was expected that could reduce postoperative pain and narcotic consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMA group | Experimental | Procedure: Arthroscopic rotator cuff repair with intraoperative periarticular injection |
| Control group | Placebo comparator | Procedure: Arthroscopic rotator cuff repair with non-injection of MMA drugs |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- rotator cuff tear
- arthroscopic surgery
Key exclusion criteria (10 listed)
- age<45 or >85
- allergies to the drugs used in the study
- acute trauma history
- history of renal disease
- history of hepatic 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 |
|---|---|---|
| Arthroscopic rotator cuff repair with intraoperative periarticular injection* Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table. * The surgical area was prepared and draped with Betadine. * Small stab incisions were made in the creation of 4 or 5 portals as needed. * A scope was explored via the arthroscopic portal into the GH joint \& subacromial space. * Repaired of rotator cuff tear was done with suture anchors. * Mixed MMA drugs(ropivacaine 300mg;40ml, morphine 10mg;1ml, cefotetan 1g; dilution to ropivacaine, epinephrine 0.3mg;0.3ml, total volume:41.3ml) and sodium hyaluronate 20mg;2ml were injected divisionally periarticular area; intra-articular(sodium hyaluronate 20ml;2ml + 10.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml). * The skin was closed with Nylon or medical staples. * Sterile dressing was applied on surgical wound. * Peripheral intravenous PCA(Patient Controlled Analgesia) was connected. | Procedure or surgery | MMA group |
| Arthroscopic rotator cuff repair with non-injection of MMA drugs* Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table. * The surgical area was prepared and draped with Betadine. * Small stab incisions were made in the creation of 4 or 5 portals as needed. * A scope was explored via the arthroscopic portal into the GH joint \& subacromial space. * Repaired of rotator cuff tear was done with suture anchors. * 43.3ml of saline was injected divisionally periarticular area; intra-articular(12.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml). * The skin was closed with Nylon or medical staples. * Sterile dressing was applied on surgical wound. * Peripheral intravenous PCA(Patient Controlled Analgesia) was connected. | Procedure or surgery | Control group |
Primary outcome
Visual Analogue Scale(VAS) for Pain
Time frame: postoperative 5 hours
1 secondary outcome
Postoperative narcotic consumption
Time frame: every 6 hours after surgery
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 12 Mar 2013.
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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.
Chris H. Jo, M.D., Ph.D principal investigator
Seoul Metropolitan Government Seoul National University Boramae Medical Center; Joint and Spine Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff repair with intraoperative periarticular injection and Arthroscopic rotator cuff repair with non-injection of MMA drugs in people with Rotator Cuff Tear, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 10 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 12 Mar 2013. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale(VAS) for Pain (time frame: postoperative 5 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 12 Mar 2013.