Rotator Cuff TearPhase 2/3NCT03380533
Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair
A Phase 2/3 study testing Buprenorphine, Multimodal Oral Scheme and Tramadol in people with Rotator Cuff Tear and Rotator Cuff Injury, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Arthroscopic rotator cuff repair is associated with poor post-operative pain management. The multimodal analgesic scheme (oral non-steroidal anti-inflammatory drugs associated with oral opioids) currently used according to the pain management guidelines is insufficient for most of these patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear, Rotator Cuff Injury, Analgesics, Opioid
- What is being tested?
- Buprenorphine, Multimodal Oral Scheme and Tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteArgentina
- Study dates
- 22 Sep 2016to 6 Apr 2021
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient diagnosed with rotator cuff injury, regardless of the type of injury.
- Patient undergoing Arthroscopic Rotator Cuff Repair
Who cannot join
- Refusal to participate or inability to understand the informed consent process.
- Inability to understand subjective scales of pain
- Regular use of narcotics
- Allergy or intolerance to drugs used in the protocol
- Consumption of drugs that interact with Buprenorphine (anticholinergics, Atropine, Belladonna, Benztropine, Dicyclomine, Diphenhydramine, Isopropamide, Procyclidine and Scopolamine, Antiarrhythmics, Amiodarone, Disopyramide, Dofetilide, Procainamide, Quinidine and Sotalol.
- Anticonvulsants; Carbamazepine, Phenobarbital, Phenytoin and Rifampin)
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- History of previous surgeries in shoulder treated with RAMR
- Previous neuromuscular deficit
- Febrile Syndrome
- Autoimmune or Rheumatologic Disease
- History of intestinal transit disorders (paralytic ileus)
- History of alcohol or drug abuse
- Patients in psychological or psychiatric treatment for anxiety disorders, personality disorders, mood disorders.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., 1181
About this study
Official title: The Use of Buprenorphine Transdermal Patches Improves Post-Operative Pain Management in Arthroscopic Rotator Cuff Repair?
Arthroscopic rotator cuff repair is associated with poor post-operative pain management. The multimodal analgesic scheme (oral non-steroidal anti-inflammatory drugs associated with oral opioids) currently used according to the pain management guidelines is insufficient for most of these patients.
There are few reports on the use of buprenorphine in post-operative pain with encouraging results. There is no evidence of its use in the management of post-operative pain of arthroscopic rotator cuff repair
Read the detailed description
Traditionally, oral opioids have been used to manage the postoperative pain of arthroscopic rotator cuff repair (ARCR) . Due to the intensity of pain, it often requires high doses of opioids, frequently associated with side effects, such as nausea, vomiting, constipation, disorientation, among others, which, in the context of an outpatient, interfere with the postoperative period, sometimes resulting in hospital readmissions. due to both the poor management of pain and the adverse effects of opioids.
Although there are invasive strategies of analgesia, such as the placement of continuous infusion catheters of analgesics in the sub-acromial space, these are methods that demand the management of the devices, in some cases requiring prolongation of hospitalization for the patient. management of the same, without being exempt from complications as any analgesic method added to those related to the method.
Currently, the post-operative analgesia strategy widely accepted globally and that used in our center, is multimodal analgesia, in which NSAIDs (Anti-Inflammatory Non-Steroids) and oral opioids are associated. A combination of both analgesic mechanisms of action is used as a basic scheme, and rescues with opioids are carried out orally. Although the literature supports its cost-benefit, this approach is often insufficient, not achieving adequate control of postoperative pain in ARCR, with 64% of our patients reporting poor pain management in the first week of post-operative and 10% that require re-entry to day hospital for pain management.
The application of transdermal opioid release patches is a method of non-invasive analgesia, which has previously been used with good results for the management of postoperative pain. In ARCR there is no evidence of its use in the management of post-operative pain The main advantages could be related to the plasma stability of the drug (buprenorphine), which implies fewer peaks and valleys of analgesia, a better compliance by the patient since it is of weekly duration and lower incidence of cognitive deterioration related to other opioids.
Compared with other opioids, buprenorphine is associated with a lower risk of abuse, overdose and poisoning due to the ceiling effect. Despite this favorable pharmacological profile, the use of buprenorphine in patches has a lower abuse rate than other forms of administering the same drug. On the one hand, the release rate of the patch may be insufficient to satisfy the compulsive desire and, to that end, the patch may be less desirable. On the other hand, the availability in the market and the way to use the patches could be other conditioning factors.
- Being tested
- Buprenorphine, Placebo Patch, Multimodal Oral Scheme, Tramadol, Placebo Tablet
- 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.
BuprenorphineDrug
Also called Buprenorphine Patch
Buprenorphine 10mg transdermal patch used during the first five postoperative days after arthroscopic rotator cuff repair
Placebo PatchDrug
Adhesive patch with the same macroscopic characteristics to the buprenorphine patch, without drugs.
Multimodal Oral SchemeDrug
Diclofenac 75mg c 12h Tramadol 50mg c 12h. Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs)
TramadolDrug
Also called Tramadol Tablet
Tramadol 50mg tablet that the patient consumes every 8 hours during the first five days
Placebo TabletDrug
Placebo tablet that the patient consumes every 8 hours during the first five days
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine Patch | Active comparator | Buprenorphine 10mg Patch + Placebo Tablet + Multimodal Oral Scheme
Multimodal Oral Scheme:
Diclofenac 75mg c 12h Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs) Receives: Drug: Buprenorphine; Drug: Multimodal Oral Scheme; Drug: Placebo Tablet |
| Tramadol Tablet | Active comparator | Placebo Patch + Tramadol 50mg Tablet + Multimodal Oral Scheme
Multimodal Oral Scheme:
Diclofenac 75mg c 12h Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs) Receives: Drug: Placebo Patch; Drug: Multimodal Oral Scheme; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
subjective perception of pain through the use of an analogous visual scale
Measured: Five days
Secondary outcomes (5)
Consumption of rescue opiods
consumption of rescue opiods
Measured: Five Days
Hours of sleep
hours of sleep
Measured: 5 days
Perception of Sickness
presence or not of nausea
Measured: 5 days
Readmissions rate
record of hospital readmissions for pain or complications related to the use of buprenorphine patches
Measured: 5 days
Misuse or abuse of opioids rate
Behaviors of misuse or abuse of opioids after the immediate postoperative period
Measured: Fourth month post operatory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start22 Sep 2016
- Primary completion8 Dec 2017
- Study completion6 Apr 2021
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BERNARDO AGUSTIN BERTONA ALTIERI, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380533
- Sponsor's protocol ID
- 2960
- Status last verified
- Apr 2021
- First submitted
- 8 Dec 2017
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Buprenorphine Transdermal Patches Improves Post-Operative Pain Management in Arthroscopic Rotator Cuff Repair?
- ClinicalTrials.gov ID
- NCT03380533
- Acronym / sponsor ID
- 2960
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 21 Dec 2017 (actual)
- 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.
Arthroscopic rotator cuff repair is associated with poor post-operative pain management. The multimodal analgesic scheme (oral non-steroidal anti-inflammatory drugs associated with oral opioids) currently used according to the pain management guidelines is insufficient for most of these patients.
There are few reports on the use of buprenorphine in post-operative pain with encouraging results. There is no evidence of its use in the management of post-operative pain of arthroscopic rotator cuff repair
Detailed description
Traditionally, oral opioids have been used to manage the postoperative pain of arthroscopic rotator cuff repair (ARCR) . Due to the intensity of pain, it often requires high doses of opioids, frequently associated with side effects, such as nausea, vomiting, constipation, disorientation, among others, which, in the context of an outpatient, interfere with the postoperative period, sometimes resulting in hospital readmissions. due to both the poor management of pain and the adverse effects of opioids.
Although there are invasive strategies of analgesia, such as the placement of continuous infusion catheters of analgesics in the sub-acromial space, these are methods that demand the management of the devices, in some cases requiring prolongation of hospitalization for the patient. management of the same, without being exempt from complications as any analgesic method added to those related to the method.
Currently, the post-operative analgesia strategy widely accepted globally and that used in our center, is multimodal analgesia, in which NSAIDs (Anti-Inflammatory Non-Steroids) and oral opioids are associated. A combination of both analgesic mechanisms of action is used as a basic scheme, and rescues with opioids are carried out orally. Although the literature supports its cost-benefit, this approach is often insufficient, not achieving adequate control of postoperative pain in ARCR, with 64% of our patients reporting poor pain management in the first week of post-operative and 10% that require re-entry to day hospital for pain management.
The application of transdermal opioid release patches is a method of non-invasive analgesia, which has previously been used with good results for the management of postoperative pain. In ARCR there is no evidence of its use in the management of post-operative pain The main advantages could be related to the plasma stability of the drug (buprenorphine), which implies fewer peaks and valleys of analgesia, a better compliance by the patient since it is of weekly duration and lower incidence of cognitive deterioration related to other opioids.
Compared with other opioids, buprenorphine is associated with a lower risk of abuse, overdose and poisoning due to the ceiling effect. Despite this favorable pharmacological profile, the use of buprenorphine in patches has a lower abuse rate than other forms of administering the same drug. On the one hand, the release rate of the patch may be insufficient to satisfy the compulsive desire and, to that end, the patch may be less desirable. On the other hand, the availability in the market and the way to use the patches could be other conditioning factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine Patch | Active comparator | Drug: Buprenorphine, Drug: Multimodal Oral Scheme, Drug: Placebo TabletBuprenorphine 10mg Patch + Placebo Tablet + Multimodal Oral Scheme Multimodal Oral Scheme: Diclofenac 75mg c 12h Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs) |
| Tramadol Tablet | Active comparator | Drug: Placebo Patch, Drug: Multimodal Oral Scheme, Drug: TramadolPlacebo Patch + Tramadol 50mg Tablet + Multimodal Oral Scheme Multimodal Oral Scheme: Diclofenac 75mg c 12h Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient diagnosed with rotator cuff injury, regardless of the type of injury.
- Patient undergoing Arthroscopic Rotator Cuff Repair
Key exclusion criteria (13 listed)
- Refusal to participate or inability to understand the informed consent process.
- Inability to understand subjective scales of pain
- Regular use of narcotics
- Allergy or intolerance to drugs used in the protocol
- Consumption of drugs that interact with Buprenorphine (anticholinergics, Atropine, Belladonna, Benztropine, Dicyclomine, Diphenhydramine, Isopropamide, Procyclidine and Scopolamine, Antiarrhythmics, Amiodarone, Disopyramide, Dofetilide, Procainamide, Quinidine and Sotalol.
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 |
|---|---|---|
| BuprenorphineAlso: Buprenorphine PatchBuprenorphine 10mg transdermal patch used during the first five postoperative days after arthroscopic rotator cuff repair | Drug | Buprenorphine Patch |
| Placebo PatchAdhesive patch with the same macroscopic characteristics to the buprenorphine patch, without drugs. | Drug | Tramadol Tablet |
| Multimodal Oral SchemeDiclofenac 75mg c 12h Tramadol 50mg c 12h. Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs) | Drug | Buprenorphine Patch, Tramadol Tablet |
| TramadolAlso: Tramadol TabletTramadol 50mg tablet that the patient consumes every 8 hours during the first five days | Drug | Tramadol Tablet |
| Placebo TabletPlacebo tablet that the patient consumes every 8 hours during the first five days | Drug | Buprenorphine Patch |
Primary outcome
Pain perception
Time frame: Five days
subjective perception of pain through the use of an analogous visual scale
5 secondary outcomes
Consumption of rescue opiods
Time frame: Five Days
Hours of sleep
Time frame: 5 days
Perception of Sickness
Time frame: 5 days
Readmissions rate
Time frame: 5 days
Misuse or abuse of opioids rate
Time frame: Fourth month post operatory
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 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Buprenorphine, Multimodal Oral Scheme and Tramadol in people with Rotator Cuff Tear and Rotator Cuff Injury, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 13 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 Apr 2021. 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 Argentina. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain perception (time frame: Five days). 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 Apr 2021.