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Completed

NCT Number: NCT03763760

High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain

The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Hip-surgery with Arthroplasty in a group of expected High Pain Responders and the effect on postoperative pain and postoperative inflammation.

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Key information

Conditions

Postoperative Pain Arthritis Catastrophizing Pain Chronic Pain Hip Osteoarthritis Joint Diseases Musculoskeletal Diseases Nausea Neurologic Manifestations Opioid Use Osteoarthritis Osteoarthritis, Hip Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Postoperative Nausea and Vomiting Rheumatic Diseases Signs and Symptoms Signs and Symptoms, Digestive Surgery Vomiting

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre Hospital, Capital Region of Denmark., Hvidovre, Denmark

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About this study

This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Hip Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders.

The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid given as an intravenous bolus after the spinal anaesthesia has been given, but before the surgery starts.

The hypothesis is that by attenuating the inflammatory response to the surgery itself by the steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon ambulation 24 hours after unilateral Hip Arthroplasty.

Patients referred to Unilateral Total Hip Arthroplasty because of Hip-osteoarthritis at Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are screened and offered inclusion in the study.

The two groups will be randomized and double blinded. One group will be treated, as the current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).

The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg bodyweight).

The patients will be monitored the first 7 days after surgery, during the admission to the hospital, and by a Pain-diary in the patients own home.

Blood tests will be taken preoperatively and postoperatively to determine the effect of the highdose steroid on the inflammatory response.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 40 and 90.
  • Booked for unilateral Hip-arthroplasty.
  • Is able to take part in the investigation(selfreported pain and nausea/vomiting)
  • Understands Danish or English, or has a translator available.
  • Signed written consent.
  • A daily use of 30 mg or more of morphine or morphine equivalents .
  • A pain catastrophizing scale(PCS) score of >20.

Exclusion criteria

  • Insulin-dependent diabetes melitus.
  • Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids).
  • Pregnancy/Breastfeeding
  • Allergies for the investigational drug.
  • A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.

Treatment and study plan

Dexamethasone

Drug

An intravenous bolus dose of dexamethasone given prior to surgery.

Other names: Dexa-ratiopharm

Primary outcomes

  1. Postoperative pain after 24 hours: VAS

    Time frame: 24 hours

    The amount of patients with moderate postoperative pain in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty.

    Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS >30 mm.

Secondary outcomes

  1. Postoperative opioid usage

    Time frame: 7 days

    The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.

  2. Postoperative antiemetics usage

    Time frame: 7 days

    The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.

  3. The inflammatory response expressed by C-reactive protein(CRP).

    Time frame: 2 days

    The inflammatory response is monitored by the blood-sample c-reactive protein(CRP) and analyzed to se the possible attenuation of the response because of dexamethasone.

  4. Postoperative pain summarized in the first 7 days

    Time frame: 7 days

    Pain summarized over the first 7 days after surgery, assessed by a summation of the Visual Analog Scale(VAS)-scores in the first 7 days as noted in the pain diary filed in by the participants.

    Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain one can imagine. Moderate pain is considered a VAS >30 mm.

Other outcomes

  1. Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward.

    Time frame: 7 days.

    An investigation into reason of why our patients remain in the hospital in the days after total Knee Arthroplasty in our Fast-Track center. This is investigated through a questionnaire previously used in a similar investigation in our center.

    The questionnaire is filled in by our project nurse. the questionnaire is a checkmark schedule with predetermined reasons to stay in hospital like low bloodpressure, sedation, dizzyness, lack of physiotherapy and medical and surgical complications.

    The outcome assesment will be descriptive.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Collaborators

  • Sygehus Lillebaelt

Registry information

Official study title

High-Dose Steroids in High Pain Responders Undergoing Total Hip-arthroplasty: A Randomized Double Blinded Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2018
Registry last updated
Jun 30, 2021

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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