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

medina medical center

Status and phase: Active, not recruiting; Phase 4

Conditions: Analgesic; Postoperative Pain; Interscalene Brachial Plexus Block; Shoulder Pain; Arthroscopy; Buprenorphine; Tramadol; Opioid Analgesia

Treatments: Drug: Tramadol; Drug: Buprenorphine transdermal patch

Study type: Interventional

Funder types: Other

Identifiers

NCT06742554

BUT002/2024

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Buprenorphine Transdermal Patch

Active Comparator group

Description:

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.

Treatment:

Drug: Buprenorphine transdermal patch

Tramadol

Active Comparator group

Description:

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.

Treatment:

Drug: Tramadol