- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04610398
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy- a Double-blinded Placebo Controlled RCT
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Dominik Kaiser, MD
- Phone Number: +41443865764
- Email: dominik.kaiser@balgrist.ch
Study Contact Backup
- Name: Sabrina Catanzaro, study nurse
- Phone Number: +41443867370
- Email: sabrina.catanzaro@balgrist.ch
Study Locations
-
-
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Zürich, Switzerland, 8008
- Uniklinik Balgrist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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"
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dexamethasone group
The patients in the dexamethasone group will receive 12mg dexamethasone (Fortecortin ®) intravenously 15-60 minutes prior to surgery while in general anasthesia as well as 12mg dexamethasone intravenously (Fortecortin®) on the first postoperative day at approx.
8.00a.m. by the investigators.
|
s. arm/group description
Other Names:
|
Placebo Comparator: Placebo/ Control group
The patients will not receive any additional drugs preoperatively.
A 0.9% NaCl Solution (NaCl B. Braun Inf Lös 0.9 % 250ml Ecoflac plus®) will be administered at approx.
8.00 a.m. on the first postoperative day by the investigators.
|
s. arm/group description
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 hours postoperatively
|
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).
|
24 hours postoperatively
|
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.
|
48 hours postoperatively
|
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.
|
48 houts postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 hours postoperatively
|
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).
|
24 hours postoperatively
|
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).
|
48 hours postoperatively
|
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.
|
48 hours postoperatively
|
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)
|
48 hours postoperatively
|
Length of hospitalization
Time Frame: after 1 week
|
The length of hospitalization will be obtained from the Patient Chart.
|
after 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Zingg, MD, PI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Vomiting
- Pain, Postoperative
- Nausea
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Dexamethasone acetate
Other Study ID Numbers
- DEXA and HAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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