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Completed

NCT Number: NCT04178109

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

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).

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Key information

Conditions

Postoperative Pain Acute Pain Neurologic Manifestations Pain Pain, Acute Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Elena Nikolakopoulou

Athens, Kifissia, 14571, Greece

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Dexketoprofen/tramadol (27mg/75mg)

Drug

Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h

Tramadol Hydrochloride

Drug

Patients in group B received IV tramadol 75mg every 8h

Paracetamol

Drug

Patients in group B received IV paracetamol 1g every 8h

Ropivacaine Hydrochloride 7.5 MG/ML

Drug

300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients

Levobupivacaine hydrochloride

Drug

10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia

Primary outcomes

  1. Pain score in 8hours

    Time frame: 8 hours

    Pain score with the visualised analogue scale in 8hours

  2. Pain score in 24hours

    Time frame: 24 hours

    Pain score with the visualised analogue scale in 24 hours

  3. Pain score in 48 hours

    Time frame: 48 hours

    Pain score with the visualised analogue scale in 48 hours

  4. Pain score in 72 hours

    Time frame: 72 hours

    Pain score with the visualised analogue scale in 72 hours

  5. Total analgesic consumption

    Time frame: 24 houra

    Total analgesic consumption as rescue analgesia the first 24 hours

Secondary outcomes

  1. Side effects

    Time frame: 72 hours

    All the side effects of the drug the first 72 hours

Sponsors and collaborators

Lead sponsor

KAT General Hospital

Other

Registry information

Official study title

EVALUATION OF ORAL USE OF DEXKETOPROFEN/TRAMADOL IN ACUTE POSTOPERATIVE PAIN IN PATIENTS UNDERGOING TOTAL HIP REPLACEMENT WITH A MINIMALLY INVASIVE ANTERIOR APPROACH (AMIS).

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2019
Registry last updated
Nov 26, 2019

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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