Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy
NCT ID: NCT06742554
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
70 participants
INTERVENTIONAL
2024-12-01
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Buprenorphine Transdermal Patch
Participants in this arm will receive a 10 mg Buprenorphine transdermal patch, applied 4 hours before shoulder arthroscopic surgery. The patch delivers a steady dose of Buprenorphine for up to 7 days, providing sustained postoperative analgesia. All participants will also undergo an interscalene brachial plexus block (ISBPB) as part of their anesthesia protocol.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine.
Buprenorphine transdermal patch
Buprenorphine Transdermal Patch (10 mg): Applied once before surgery for continuous pain control.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine.
Tramadol
Participants in this arm will receive Tramadol for postoperative pain management. The medication will be administered at a dose of 100 mg every 8 hours as needed, beginning after the interscalene brachial plexus block (ISBPB) wears off.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine.
Tramadol
Tramadol: Administered orally or intravenously at a standard dose of 100 mg every 8 hours, based on patient-reported pain levels.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine.
Interventions
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Buprenorphine transdermal patch
Buprenorphine Transdermal Patch (10 mg): Applied once before surgery for continuous pain control.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine.
Tramadol
Tramadol: Administered orally or intravenously at a standard dose of 100 mg every 8 hours, based on patient-reported pain levels.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine.
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective shoulder arthroscopy.
* Classified as ASA (American Society of Anesthesiologists) physical status I or II.
* Able to provide informed consent.
* Willing to comply with study protocols and follow-up assessments
Exclusion Criteria
* History of substance abuse, opioid dependency, or chronic pain requiring ongoing analgesic therapy.
* Pregnant or breastfeeding individuals.
* Presence of severe hepatic, renal, or respiratory disease.
* Any psychiatric or neurological condition that might interfere with pain perception or reporting (e.g., dementia, severe anxiety).
* Participation in another clinical trial within the last 30 days.
* Inability to apply or tolerate a transdermal patch (e.g., due to skin disorders or sensitivities).
* Contraindications to interscalene brachial plexus block, such as infection at the site, coagulopathy, or pre-existing neuropathy in the upper limb.
18 Years
65 Years
ALL
No
Sponsors
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medina medical center
OTHER
Responsible Party
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Ahmed Gamal Salah Elsawy
Anesthesia and Pain Management Consultant, Director of Day Case Surgeries
Locations
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Medina Medical Center
Madinah, , Saudi Arabia
Countries
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References
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Arshad Z, Prakash R, Gautam S, Kumar S. Comparison between Transdermal Buprenorphine and Transdermal Fentanyl for Postoperative Pain Relief after Major Abdominal Surgeries. J Clin Diagn Res. 2015 Dec;9(12):UC01-4. doi: 10.7860/JCDR/2015/16327.6917. Epub 2015 Dec 1.
Other Identifiers
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BUT002/2024
Identifier Type: -
Identifier Source: org_study_id