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

Phase 4Active Not RecruitingNCT06742554

medina medical center70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Postoperative Pain Shoulder Pain Opioid Analgesia Tramadol Buprenorphine Arthroscopy

Interventions

Buprenorphine transdermal patchDRUG

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.

TramadolDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

Incidence of Adverse Effects

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.

Time frame: From the time of surgery (Day 0) to 72 hours postoperatively

Patient Satisfaction (Likert Scale)

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

Time frame: At 72 hours postoperatively

Early Mobilization and Rehabilitation Adherence

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.

Time frame: From 24 to 72 hours postoperatively.

Total Rescue Analgesic Consumption

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.