Clinical trial NCT05120076: Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy
Official title: Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy- a Double-blinded Placebo Controlled RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain
Postoperative Nausea
Amount of Postoperative Opioid Use in Milligrams
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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"

Primary outcomes:
measure: Postoperative pain level
timeFrame: 6 hours postoperatively
measure: Postoperative pain level
timeFrame: 24 hours postoperatively
measure: Amount of opiates (morphinequivalent) consumed
timeFrame: 48 hours postoperatively
measure: Amount of anti-emetics consumed (Ondansetron)
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
timeFrame: 6 hours postoperatively
measure: Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
timeFrame: 24 hours postoperatively
measure: Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
timeFrame: 48 hours postoperatively
measure: Number of vomiting events
timeFrame: 48 hours postoperatively
measure: Physical therapy milestones 1
timeFrame: 1 week postoperatively
measure: Physical therapy milestones 2
timeFrame: 1 week postoperatively
measure: Physical therapy milestones 3
timeFrame: 1 week postoperatively
measure: Length of hospitalization
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Uniklinik Balgrist
Study officials:
affiliation: Study Principal Investigator
name: Patrick Zingg, MD
role: PRINCIPAL_INVESTIGATOR
References: