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

December 18, 2024 updated by: Ahmed Gamal Salah Elsawy, medina medical center

Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy: a Randomized Controlled Trial.

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Medina, Saudi Arabia, 42313
        • Medina Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Buprenorphine transdermal patch

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.
Active Comparator: 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.
Drug: Tramadol

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the time of surgery (Day 0) to 72 hours postoperatively.
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.
Pain intensity will be measured using the The numeric rating scale , recorded at 6, 12, 24, 48, and 72 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Effects
Time Frame: 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.
From the time of surgery (Day 0) to 72 hours postoperatively
Patient Satisfaction (Likert Scale)
Time Frame: 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
At 72 hours postoperatively
Early Mobilization and Rehabilitation Adherence
Time Frame: 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.
From 24 to 72 hours postoperatively.
Total Rescue Analgesic Consumption
Time Frame: 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.
From the time of surgery (Day 0) to 72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

medina medical center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUT002/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including primary and secondary outcome measures, will be shared.

IPD Sharing Time Frame

Data will be made available upon publication of the study results in a peer-reviewed journal

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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