Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.

Overview

Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions . When unrelieved or poorly controlled, it is associated with medical complications, poor patient satisfaction and increased risk of developing chronic pain. Dexketoprofen is a new NSAID treating acute postoperative pain and when it combined with tramadol may have a better effect. The purpose of this study is to evaluate the analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior approach (AMIS).

Full Title of Study: “EVALUATION OF ORAL USE OF DEXKETOPROFEN/TRAMADOL IN ACUTE POSTOPERATIVE PAIN IN PATIENTS UNDERGOING TOTAL HIP REPLACEMENT WITH A MINIMALLY INVASIVE ANTERIOR APPROACH (AMIS).”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: November 10, 2019

Interventions

  • Drug: Dexketoprofen/tramadol (27mg/75mg)
    • Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h
  • Drug: Tramadol hydrochloride
    • Patients in group B received IV tramadol 75mg every 8h
  • Drug: Paracetamol
    • Patients in group B received IV paracetamol 1g every 8h
  • Drug: Ropivacaine Hydrochloride 7.5 MG/ML
    • 300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients
  • Drug: Levobupivacaine Hydrochloride
    • 10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia

Arms, Groups and Cohorts

  • Active Comparator: Group A
    • Group A was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg. Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine. Group A was given the oral combination dexketoprofen/tramadole (25mg/75mg) 2h after surgery every 8h for 72h.
  • Placebo Comparator: Group B
    • Group B was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg. Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine. Group B received postoperative analgesia with intravenous tramadole 75mg and paracetamol 1g every 8h with the first dose beginning 2h after the end of the surgery. For 72h

Clinical Trial Outcome Measures

Primary Measures

  • Pain score in 8hours
    • Time Frame: 8 hours
    • Pain score with the visualised analogue scale in 8hours
  • Pain score in 24hours
    • Time Frame: 24 hours
    • Pain score with the visualised analogue scale in 24 hours
  • Pain score in 48 hours
    • Time Frame: 48 hours
    • Pain score with the visualised analogue scale in 48 hours
  • Pain score in 72 hours
    • Time Frame: 72 hours
    • Pain score with the visualised analogue scale in 72 hours
  • Total analgesic consumption
    • Time Frame: 24 houra
    • Total analgesic consumption as rescue analgesia the first 24 hours

Secondary Measures

  • Side effects
    • Time Frame: 72 hours
    • All the side effects of the drug the first 72 hours

Participating in This Clinical Trial

Inclusion Criteria

  • unilateral total hip arthroplasty with a direct anterior minimal invasive technique – ASA score I or II – signed written informed consent form – 3 days hospitalization – 45-80 years old – primary Total hip arthroplasty Exclusion Criteria:

  • allergy to any given drugs – contraindications for spinal anesthesia – active bleeding – renal failure ( gfr< 90ml/h) – hepatic failure ( abnormal sgot,sgpt,γgt) – heart failure – history of gastrointestinal bleeding

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • KAT General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elena Nikolakopoulou, MD – KAT General Hospital

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