This study focuses on elderly patients with femoral neck or intertrochanteric fractures Hip fracture, elderly patients, postoperative pain, pain management, Esflurbiprofen patch, transdermal NSAIDs, randomized controlled trial, hemiarthroplasty, cephalomedullary nailing, opioid comsumption, functional recovery, multimodal analgesia
Conditions
Interventions
Participants receive Esflurbiprofen transdermal patch 40 mg applied once daily on the operated side, about 7 to 8 cm away from the surgical incision, starting immediately after wound closure. The patc
Experimental Drug,Placebo Comparator Drug
Esflurbiprofen transdermal patch,Placebo transdermal patch
Sponsors
Tinn Punnachet
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 60 and 85 years 2. Diagnosed with hip fracture, including: a. Femoral neck fracture undergoing with bipolar hemiarthroplasty b. Intertrochanteric fracture undergoing with cephalomedullary nailing Able to communicate and comply with postoperative pain assessment procedures
Exclusion criteria
Exclusion criteria: 1. Contraindication to NSAIDs: patients with a history of allergy or hypersensitivity to NSAIDs 2. History of severe gastrointestinal, cardiovascular, or renal disease, including chronic kidney disease stage IV to V 3. Use of anticoagulant or antiplatelet medications that may increase the risk of bleeding 4. Skin problems at or near the intended patch application site 5. Presence of additional fractures or injuries that may interfere with accurate postoperative pain assessment 6. Inability to comply with study procedures, such as due to language or communication barriers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain score (VAS at rest and in motion) At postoperative hours 6, 12, 24, 36, 48, 72, day 7, day 14, week 6, and month 3. Pain intensity measured using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain imaginable), assessed at rest and during hip motion on the operated side. | — |
Secondary
| Measure | Time frame |
|---|---|
| Barthel Index for Activities of Daily Living (ADL) At postoperative hours 24, 48, 72, day 7, day 14, week 6, and month 3. Functional ability assessed using the Barthel ADL score, evaluated by trained staff to measure postoperative recovery and independence in daily activities.,Total morphine consumption At postoperative hours 6, 12, 24, 36, and 48. Cumulative morphine dose (mg) ,Length of hospital stay At discharge. Number of days from the date of surgery to hospital discharge as recorded in medical records.,Adverse effects of Esflurbiprofen patch At postoperative hour 72 and during follow-up visits (day 7 and day 14). Incidence of local skin reactions (e.g., dermatitis) and changes in renal function (serum creatinine, estimated glomerular filtration rate). | — |
Countries
Thailand
Contacts
Public ContactTinn Punnachet
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed