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

Phase 4

Active, not recruiting

• Conditions: Postoperative Pain; Shoulder Pain; Opioid Analgesia; Tramadol; Buprenorphine; Arthroscopy; Interscalene Brachial Plexus Block; Analgesic
• Interventions: Drug: Buprenorphine transdermal patch; Drug: Tramadol

• Registration Number: NCT06742554
• Lead Sponsor: medina medical center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine Transdermal Patch	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.
Tramadol	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medina Medical Center; 🇸🇦 Medina, Saudi Arabia