Pain, PostoperativePhase 3NCT04610398
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy
A Phase 3 study testing Dexamethasone 4mg and NaCl 0.9% in people with Pain, Postoperative and Nausea, Postoperative, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after hip arthroscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Nausea, Postoperative, Opioid Use
- What is being tested?
- Dexamethasone 4mg and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Mar 2021to 30 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 10Show fewer
- 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"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy- a Double-blinded Placebo Controlled RCT
The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after hip arthroscopy.
Read the 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.
- Conditions
- Pain, Postoperative, Nausea, Postoperative, Opioid Use
- Being tested
- Dexamethasone 4mg, NaCl 0.9%
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4mgDrug
Also called Fortecortin Inject (Merck (Switzerland))
- arm/group description
NaCl 0.9%Drug
Also called NaCL Braun (B.Braun Medical)
- arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Active comparator | 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. Receives: Drug: Dexamethasone 4mg |
| Placebo/ Control group | Placebo comparator | 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. Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain level
The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).
Measured: 6 hours postoperatively
Postoperative pain level
The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).
Measured: 24 hours postoperatively
Amount of opiates (morphinequivalent) consumed
We will assess the amount of Opiates the Patient needed due to the performed Surgery during the hospital stay.
Measured: 48 hours postoperatively
Amount of anti-emetics consumed (Ondansetron)
We will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.
Measured: 48 houts postoperatively
Secondary outcomes (6)
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).
Measured: 6 hours postoperatively
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).
Measured: 24 hours postoperatively
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).
Measured: 48 hours postoperatively
Number of vomiting events
We will Count the number of vomiting Events postoperatively as a direct marker for postoperative Nausea.
Measured: 48 hours postoperatively
Physical therapy milestones
Our patients will be instructed and perform different postoperative Rehabilitation steps including (first steps in the hallway, Walking up and down stairs, bicycle Ergometer)
Measured: 48 hours postoperatively
Length of hospitalization
The length of hospitalization will be obtained from the Patient Chart.
Measured: after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start11 Mar 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Zingg, MD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610398
- Sponsor's protocol ID
- DEXA and HAS
- Status last verified
- Sep 2023
- First submitted
- 6 Oct 2020
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: If requested the individual participant data will be made available to other researchers.
Publications
Kaiser D, Hoch A, Dimitriou D, Groeber T, Bomberg H, Aguirre JA, Eichenberger U, Zingg PO. Perioperative Intravenous Dexamethasone Significantly Reduces Postoperative Opioid Requirement and Nausea After Unilateral Elective Hip Arthroscopy: A Randomized Double-blinded Placebo-controlled Trial. Am J Sports Med. 2024 Apr;52(5):1165-1172. doi: 10.1177/03635465241232157. Epub 2024 Mar 8.
PubMed 38456291
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy- a Double-blinded Placebo Controlled RCT
- ClinicalTrials.gov ID
- NCT04610398
- Acronym / sponsor ID
- DEXA and HAS
- Conditions
- Pain, Postoperative, Nausea, Postoperative, Opioid Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after hip arthroscopy.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Active comparator | Drug: Dexamethasone 4mgThe 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. |
| Placebo/ Control group | Placebo comparator | Drug: NaCl 0.9%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Age ≥ 18 years
Key exclusion criteria (10 listed)
- • Chronic pain patient, chronic lower back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 4mgAlso: Fortecortin Inject (Merck (Switzerland))s. arm/group description | Drug | Dexamethasone group |
| NaCl 0.9%Also: NaCL Braun (B.Braun Medical)s. arm/group description | Drug | Placebo/ Control group |
Primary outcome
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).
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).
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.
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.
6 secondary outcomes
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Time frame: 6 hours postoperatively
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Time frame: 24 hours postoperatively
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Time frame: 48 hours postoperatively
Number of vomiting events
Time frame: 48 hours postoperatively
Physical therapy milestones
Time frame: 48 hours postoperatively
Length of hospitalization
Time frame: after 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 38456291Kaiser D, Hoch A, Dimitriou D, Groeber T, Bomberg H, Aguirre JA, Eichenberger U, Zingg PO. Perioperative Intravenous Dexamethasone Significantly Reduces Postoperative Opioid Requirement and Nausea After Unilateral Elective Hip Arthroscopy: A Randomized Double-blinded Placebo-controlled Trial. Am J Sports Med. 2024 Apr;52(5):1165-1172. doi: 10.1177/03635465241232157. Epub 2024 Mar 8.
- Individual participant dataSharing planned: No. If requested the individual participant data will be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Zingg, MD principal investigator
PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone 4mg and NaCl 0.9% in people with Pain, Postoperative and Nausea, Postoperative, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain level (time frame: 6 hours postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.