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NCT Number: NCT05120076

Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy

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

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

Bernese periacetabular osteotomy (PAO) 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) to a control group (placebo) (3ml 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 up to 60 patients receiving elective unilateral PAO 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 periacetabular osteotomy for any reason
  • 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 4 Mg/mL Injectable Solution

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 (worst 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 (worst possible pain).

  3. Amount of opiates (morphinequivalent) consumed

    Time frame: 48 hours postoperatively

    The authors 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 hours postoperatively

    The authors 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). (0% worst, 100% best)

  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).(0% worst, 100% best)

  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).(0% worst, 100% best)

  4. Number of vomiting events

    Time frame: 48 hours postoperatively

    The authors will count the number of vomiting events postoperatively as a direct marker for postoperative Nausea.

  5. Physical therapy milestones 1

    Time frame: 1 week postoperatively

    First steps in the hallway

  6. Physical therapy milestones 2

    Time frame: 1 week postoperatively

    Walk up stairs

  7. Physical therapy milestones 3

    Time frame: 1 week postoperatively

    Bicycle ergometer can be used indipendently by the patient

  8. Length of hospitalization

    Time frame: 2 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dominik Kaiser, MD

CONTACT

[email protected]

+41443865764

Sabrina Catanzaro, study nurse

CONTACT

[email protected]

+41443867370

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy- a Double-blinded Placebo Controlled RCT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2021
Registry last updated
Aug 12, 2024

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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