Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy: a Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Postoperative pain score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: Buprenorphine transdermal patch (Drug)
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.
Intervention: Tramadol (Drug)
Outcomes
Primary Outcomes
Postoperative pain score
Time Frame: 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
Time Frame: 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 Outcomes
- Incidence of Adverse Effects(From the time of surgery (Day 0) to 72 hours postoperatively)
- Patient Satisfaction (Likert Scale)(At 72 hours postoperatively)
- Early Mobilization and Rehabilitation Adherence(From 24 to 72 hours postoperatively.)
- Total Rescue Analgesic Consumption(From the time of surgery (Day 0) to 72 hours postoperatively)
Investigators
Ahmed Gamal Salah Elsawy
Anesthesia and Pain Management Consultant, Director of Day Case Surgeries
medina medical center