Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-09 @ 7:14 AM
Study NCT ID:
NCT03380533
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2017-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2017-12-08', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain perception', 'timeFrame': 'Five days', 'description': 'subjective perception of pain through the use of an analogous visual scale'}], 'secondaryOutcomes': [{'measure': 'Consumption of rescue opiods', 'timeFrame': 'Five Days', 'description': 'consumption of rescue opiods'}, {'measure': 'Hours of sleep', 'timeFrame': '5 days', 'description': 'hours of sleep'}, {'measure': 'Perception of Sickness', 'timeFrame': '5 days', 'description': 'presence or not of nausea'}, {'measure': 'Readmissions rate', 'timeFrame': '5 days', 'description': 'record of hospital readmissions for pain or complications related to the use of buprenorphine patches'}, {'measure': 'Misuse or abuse of opioids rate', 'timeFrame': 'Fourth month post operatory', 'description': 'Behaviors of misuse or abuse of opioids after the immediate postoperative period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tear', 'Rotator Cuff Injury', 'Analgesics, Opioid', 'Buprenorphine']}, 'descriptionModule': {'briefSummary': '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.\n\nThere 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', 'detailedDescription': '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.\n\nAlthough 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.\n\nCurrently, 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.\n\nThe 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.\n\nCompared 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed with rotator cuff injury, regardless of the type of injury.\n* Patient undergoing Arthroscopic Rotator Cuff Repair\n\nExclusion Criteria:\n\n1. Refusal to participate or inability to understand the informed consent process.\n2. Inability to understand subjective scales of pain\n3. Regular use of narcotics\n4. Allergy or intolerance to drugs used in the protocol\n5. 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.\n\n Anticonvulsants; Carbamazepine, Phenobarbital, Phenytoin and Rifampin)\n6. History of previous surgeries in shoulder treated with RAMR\n7. Previous neuromuscular deficit\n8. Febrile Syndrome\n9. Autoimmune or Rheumatologic Disease\n10. History of intestinal transit disorders (paralytic ileus)\n11. History of alcohol or drug abuse\n12. Patients in psychological or psychiatric treatment for anxiety disorders, personality disorders, mood disorders.'}, 'identificationModule': {'nctId': 'NCT03380533', 'briefTitle': 'Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'The Use of Buprenorphine Transdermal Patches Improves Post-Operative Pain Management in Arthroscopic Rotator Cuff Repair?', 'orgStudyIdInfo': {'id': '2960'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Buprenorphine Patch', 'description': 'Buprenorphine 10mg Patch + Placebo Tablet + Multimodal Oral Scheme\n\nMultimodal Oral Scheme:\n\nDiclofenac 75mg c 12h Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs)', 'interventionNames': ['Drug: Buprenorphine', 'Drug: Multimodal Oral Scheme', 'Drug: Placebo Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol Tablet', 'description': 'Placebo Patch + Tramadol 50mg Tablet + Multimodal Oral Scheme\n\nMultimodal Oral Scheme:\n\nDiclofenac 75mg c 12h Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs)', 'interventionNames': ['Drug: Placebo Patch', 'Drug: Multimodal Oral Scheme', 'Drug: Tramadol']}], 'interventions': [{'name': 'Buprenorphine', 'type': 'DRUG', 'otherNames': ['Buprenorphine Patch'], 'description': 'Buprenorphine 10mg transdermal patch used during the first five postoperative days after arthroscopic rotator cuff repair', 'armGroupLabels': ['Buprenorphine Patch']}, {'name': 'Placebo Patch', 'type': 'DRUG', 'description': 'Adhesive patch with the same macroscopic characteristics to the buprenorphine patch, without drugs.', 'armGroupLabels': ['Tramadol Tablet']}, {'name': 'Multimodal Oral Scheme', 'type': 'DRUG', 'description': 'Diclofenac 75mg c 12h Tramadol 50mg c 12h. Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs)', 'armGroupLabels': ['Buprenorphine Patch', 'Tramadol Tablet']}, {'name': 'Tramadol', 'type': 'DRUG', 'otherNames': ['Tramadol Tablet'], 'description': 'Tramadol 50mg tablet that the patient consumes every 8 hours during the first five days', 'armGroupLabels': ['Tramadol Tablet']}, {'name': 'Placebo Tablet', 'type': 'DRUG', 'description': 'Placebo tablet that the patient consumes every 8 hours during the first five days', 'armGroupLabels': ['Buprenorphine Patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1181', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'BERNARDO AGUSTIN BERTONA ALTIERI', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}