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This study compares the efficacy, safety, and patient satisfaction of the Buprenorphine 10 mg transdermal patch versus Tramadol for postoperative analgesia in shoulder arthroscopic surgery. The study hypothesizes that Buprenorphine provides superior pain relief with fewer side effects compared to Tramadol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine Transdermal Patch | Active Comparator | 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. |
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| Tramadol | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score | Postoperative pain scores measured using the The Numeric Rating Scale over 72 hours. It involves asking participants to rate their pain on a scale of 0 to 10, where:
| Pain intensity will be measured using the The numeric rating scale , recorded at 6, 12, 24, 48, and 72 hours after surgery. |
| Duration of Effective Analgesia | The time from the full recovery from the interscalene brachial plexus block (ISBPB) until 72 hrs postoperatively. | From the time of surgery (Day 0) to 72 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Effects | he number of participants experiencing adverse effects (e.g., nausea, vomiting, dizziness, sedation, or skin irritation) will be recorded. Data will be collected through direct patient reports and clinical observations. | From the time of surgery (Day 0) to 72 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medina Medical Center | Madinah | 42313 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26816973 | Background | 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. |
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De-identified individual participant data, including primary and secondary outcome measures, will be shared.
Data will be made available upon publication of the study results in a peer-reviewed journal
Researchers and healthcare professionals conducting methodologically sound and ethically approved research.
Individuals or institutions with research objectives aligned with the scope of the study, such as meta-analyses or systematic reviews
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This is a randomized, parallel-assignment study where participants are allocated to one of two intervention groups. Group A will receive a Buprenorphine 10 mg transdermal patch applied 4 hours prior to surgery, providing sustained analgesia for up to 72 hours postoperatively. Group B will receive Tramadol at a standard dosage (100 mg every 8 hours as needed for pain) starting postoperatively. Both groups will receive interscalene brachial plexus block (ISBPB) as part of their intraoperative anesthesia.
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| Tramadol | Drug | 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. |
|
| Patient Satisfaction (Likert Scale) |
Patient satisfaction with pain management will be assessed using a 5-point Likert scale, where 1 indicates "very dissatisfied" and 5 indicates "very satisfied." Higher scores reflect better patient satisfaction |
| At 72 hours postoperatively |
| Early Mobilization and Rehabilitation Adherence | The ability to perform early mobilization and adhere to physiotherapy protocols (e.g., range-of-motion exercises) will be assessed by physical therapists. This will be rated as "Full adherence," "Partial adherence," or "No adherence." Full adherence indicates a better outcome. | From 24 to 72 hours postoperatively. |
| Total Rescue Analgesic Consumption | The total amount of rescue analgesics (e.g., acetaminophen or additional opioids) required by each participant will be recorded in milligrams. Lower consumption indicates better efficacy of the primary analgesic. | From the time of surgery (Day 0) to 72 hours postoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
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