Active — Not RecruitingPhase 4

Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy

Saudi Arabia70 participantsStarted 2024-12-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative pain score

Timeframe: 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

Timeframe: From the time of surgery (Day 0) to 72 hours postoperatively.

Trial details

NCT IDNCT06742554

Sponsormedina medical center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Postoperative Pain trials