Postoperative Pain, Shoulder Pain, Opioid Analgesia, Tramadol, Buprenorphine, Arthroscopy, Interscalene Brachial Plexus Block, Analgesic
Conditions
Keywords
buprinorphin, transdermal, tramadol
Brief summary
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.
Interventions
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.
DRUGTramadol
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.
Sponsors
medina medical center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 65 years. * 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
* Known allergy or hypersensitivity to Buprenorphine, Tramadol, or any related compounds. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score | Pain intensity will be measured using the The numeric rating scale , recorded at 6, 12, 24, 48, and 72 hours after surgery. | 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: * 0 represents No Pain * 10 represents Worst Possible Pain Lower scores indicate better outcomes. |
| Duration of Effective Analgesia | From the time of surgery (Day 0) to 72 hours postoperatively. | The time from the full recovery from the interscalene brachial plexus block (ISBPB) until 72 hrs postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Effects | From the time of surgery (Day 0) to 72 hours postoperatively | 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. |
| Patient Satisfaction (Likert Scale) | At 72 hours postoperatively | 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 |
| Early Mobilization and Rehabilitation Adherence | From 24 to 72 hours postoperatively. | 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. |
| Total Rescue Analgesic Consumption | From the time of surgery (Day 0) to 72 hours postoperatively | 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. |
Countries
Saudi Arabia
Outcome results
None listed