Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    60
  • sponsor
    Balgrist University Hospital
Updated on 23 April 2022
postoperative pain
nausea
dexamethasone
Accepts healthy volunteers

Summary

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

Description

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.

Details
Condition Pain, Postoperative Nausea, Amount of Postoperative Opioid Use in Milligrams
Treatment Nacl 0.9%, Dexamethasone 4 Mg/mL Injectable Solution
Clinical Study IdentifierNCT05120076
SponsorBalgrist University Hospital
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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