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Active, Not Recruiting

NCT Number: NCT06742554

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Postoperative Pain Analgesic Arthralgia Arthroscopy Buprenorphine Interscalene Brachial Plexus Block Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Opioid Analgesia Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shoulder Pain Signs and Symptoms Tramadol

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medina Medical Center

Madinah, 42313, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

medina medical center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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