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

NCT06742554 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: BUT002/2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

buprinorphin; transdermal; tramadol

Outcome Measures

Primary Outcomes (2)

• Postoperative pain score

  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.

  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

  The time from the full recovery from the interscalene brachial plexus block (ISBPB) until 72 hrs postoperatively.

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

Secondary Outcomes (4)

• 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

Study Arms (2)

Buprenorphine Transdermal Patch

ACTIVE COMPARATOR

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.

Drug: Buprenorphine transdermal patch

Tramadol

ACTIVE COMPARATOR

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.

Drug: Tramadol

Interventions

Buprenorphine transdermal patch DRUG

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.

Buprenorphine Transdermal Patch

Tramadol DRUG

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.

Tramadol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• medina medical center: lead

Study Sites (1)

Medina Medical Center

Madinah, 42313, Saudi Arabia

Location

Related Publications (1)

• Arshad Z, Prakash R, Gautam S, Kumar S. Comparison between Transdermal Buprenorphine and Transdermal Fentanyl for Postoperative Pain Relief after Major Abdominal Surgeries. J Clin Diagn Res. 2015 Dec;9(12):UC01-4. doi: 10.7860/JCDR/2015/16327.6917. Epub 2015 Dec 1.

  PMID: 26816973 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia and Pain Management Consultant, Director of Day Case Surgeries

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: December 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 30, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be made available upon publication of the study results in a peer-reviewed journal
• Access Criteria: Researchers and healthcare professionals conducting methodologically sound and ethically approved research. Individuals or institutions with research objectives aligned with the scope of the study, such as meta-analyses or systematic reviews

Locations

SA (1)