Clinical trial NCT06742554: Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy
Official title: Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain
Shoulder Pain
Opioid Analgesia
Tramadol
Buprenorphine
Arthroscopy
Interscalene Brachial Plexus Block
Analgesic
Keywords: buprinorphin
transdermal
tramadol
Lead sponsor: medina medical center
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain score
timeFrame: Pain intensity will be measured using the The numeric rating scale , recorded at 6, 12, 24, 48, and 72 hours after surgery.
measure: Duration of Effective Analgesia
timeFrame: From the time of surgery (Day 0) to 72 hours postoperatively.
Secondary outcomes:
measure: Incidence of Adverse Effects
timeFrame: From the time of surgery (Day 0) to 72 hours postoperatively
measure: Patient Satisfaction (Likert Scale)
timeFrame: At 72 hours postoperatively
measure: Early Mobilization and Rehabilitation Adherence
timeFrame: From 24 to 72 hours postoperatively.
measure: Total Rescue Analgesic Consumption
timeFrame: From the time of surgery (Day 0) to 72 hours postoperatively
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: Medina Medical Center
Study officials:
References:
citation: 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.