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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05120076
Other study ID # DEXA and PAO
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 16, 2021
Est. completion date August 31, 2023

Study information

Verified date October 2022
Source Balgrist University Hospital
Contact Dominik Kaiser, MD
Phone +41443865764
Email dominik.kaiser@balgrist.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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"

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone 4 Mg/mL Injectable Solution
s. arm/group description
NaCl 0.9%
s. arm/group description

Locations

Country Name City State
Switzerland Uniklinik Balgrist Zürich

Sponsors (1)

Lead Sponsor Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain level The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain). 6 hours postoperatively
Primary Postoperative pain level The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain). 24 hours postoperatively
Primary Amount of opiates (morphinequivalent) consumed The authors will assess the amount of Opiates the Patient needed due to the performed Surgery during the hospital stay. 48 hours postoperatively
Primary Amount of anti-emetics consumed (Ondansetron) The authors will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay. 48 hours postoperatively
Secondary Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R). (0% worst, 100% best) 6 hours postoperatively
Secondary Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).(0% worst, 100% best) 24 hours postoperatively
Secondary Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).(0% worst, 100% best) 48 hours postoperatively
Secondary Number of vomiting events The authors will count the number of vomiting events postoperatively as a direct marker for postoperative Nausea. 48 hours postoperatively
Secondary Physical therapy milestones 1 First steps in the hallway 1 week postoperatively
Secondary Physical therapy milestones 2 Walk up stairs 1 week postoperatively
Secondary Physical therapy milestones 3 Bicycle ergometer can be used indipendently by the patient 1 week postoperatively
Secondary Length of hospitalization The length of hospitalization will be obtained from the Patient Chart. 2 weeks
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