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Completed

NCT Number: NCT04610398

Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy

The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after hip arthroscopy.

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Key information

Conditions

Pain, Postoperative Nausea Nausea, Postoperative Neurologic Manifestations Opioid Use Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Uniklinik Balgrist

Zurich, 8008, Switzerland

About this study

Hip arthroscopy (HAS) is a standard procedure with good mid and long-term results. Postoperative pain is a great concern and postoperative pain management of great importance. High demand for opiates and the associated side effects especially nausea limit the postoperative rehabilitation.

Promising results to reduce postoperative pain and nausea have been achieved by perioperative dexamethasone, which has a strong anti-inflammatory effect reducing pain and inflammation as well as a strong anti-emetic effect, especially in total hip replacement.

It is our goal to compare the effect of perioperative intravenous dexamethasone (3x 4mg Amp. Fortecortin =12mg prior to surgery and 3x4mg Amp. Fortecortin = 12mg at 8.00am of the first postoperative day in 250ml saline solution) to a control group (placebo) (1x 250ml saline solution postoperative day 1 at 8.00am) regarding pain level, opiate consumption, postoperative nausea and patient satisfaction.

A double-blinded prospective randomized control trial including 60 patients receiving elective unilateral HAS will be conducted.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • • Age ≥ 18 years
  • general anasthesia
  • Elective isolated unilateral HAS for any reason
  • No Prior hip surgery
  • Written informed consent as documented by signature (Appendix Informed Consent Form)
  • Competent German language skills

Exclusion criteria

  • • Chronic pain patient, chronic lower back pain
  • Steroid or immunosuppressive drugs used within 6 months of surgery
  • Renal failure, hepatic failure
  • Relevant allergies
  • Pregnancy/ Breast feeding
  • Contraindications for Fortecortin treatment according to Swissmedic
  • Previous enrollment into the current study
  • Participation in another study with investigational drug within the 30 days preceding and during the present study
  • Known or suspected non-compliance, drug or alcohol abuse
  • Illness according to "Warnings and Precautions of Dexamethasone and NaCl"

Treatment and study plan

Dexamethasone 4mg

Drug

s. arm/group description

Other names: Fortecortin Inject (Merck (Switzerland))

NaCl 0.9%

Drug

s. arm/group description

Other names: NaCL Braun (B.Braun Medical)

Primary outcomes

  1. Postoperative pain level

    Time frame: 6 hours postoperatively

    The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).

  2. Postoperative pain level

    Time frame: 24 hours postoperatively

    The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).

  3. Amount of opiates (morphinequivalent) consumed

    Time frame: 48 hours postoperatively

    We will assess the amount of Opiates the Patient needed due to the performed Surgery during the hospital stay.

  4. Amount of anti-emetics consumed (Ondansetron)

    Time frame: 48 houts postoperatively

    We will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.

Secondary outcomes

  1. Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire

    Time frame: 6 hours postoperatively

    Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).

  2. Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire

    Time frame: 24 hours postoperatively

    Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).

  3. Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire

    Time frame: 48 hours postoperatively

    Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).

  4. Number of vomiting events

    Time frame: 48 hours postoperatively

    We will Count the number of vomiting Events postoperatively as a direct marker for postoperative Nausea.

  5. Physical therapy milestones

    Time frame: 48 hours postoperatively

    Our patients will be instructed and perform different postoperative Rehabilitation steps including (first steps in the hallway, Walking up and down stairs, bicycle Ergometer)

  6. Length of hospitalization

    Time frame: after 1 week

    The length of hospitalization will be obtained from the Patient Chart.

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy- a Double-blinded Placebo Controlled RCT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2020
Registry last updated
Sep 25, 2023

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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