PainPhase 3NCT05120076
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy
A Phase 3 study testing Dexamethasone 4 Mg/mL Injectable Solution and NaCl 0.9% in people with Pain and Postoperative Nausea, 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 periacetabular osteotomy. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative Nausea, Amount of Postoperative Opioid Use in Milligrams
- What is being tested?
- Dexamethasone 4 Mg/mL Injectable Solution 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
- 16 Jul 2021to 31 Aug 2024
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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 9Show 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.
Switzerland1 site, 1 recruiting
- Recruiting
Uniklinik Balgrist
Zurich, 8008
Dominik Kaiser, +41443865764, dominik.kaiser@balgrist.ch
Patrickt Zingg, patrick.zingg@balgrist.ch
About this study
Official title: Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy- a Double-blinded Placebo Controlled RCT
The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after periacetabular osteotomy.
Read the 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.
- Being tested
- Dexamethasone 4 Mg/mL Injectable Solution, NaCl 0.9%
- Medical subject headings
- Pain, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4 Mg/mL Injectable SolutionDrug
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 4 Mg/mL Injectable Solution |
| Placebo/ Control group | Placebo comparator | The patients will not receive any additional drugs preoperatively. 3ml of 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 (worst 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 (worst possible pain).
Measured: 24 hours postoperatively
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.
Measured: 48 hours postoperatively
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.
Measured: 48 hours postoperatively
Secondary outcomes (8)
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)
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).(0% worst, 100% best)
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).(0% worst, 100% best)
Measured: 48 hours postoperatively
Number of vomiting events
The authors will count the number of vomiting events postoperatively as a direct marker for postoperative Nausea.
Measured: 48 hours postoperatively
Physical therapy milestones 1
First steps in the hallway
Measured: 1 week postoperatively
Physical therapy milestones 2
Walk up stairs
Measured: 1 week postoperatively
Physical therapy milestones 3
Bicycle ergometer can be used indipendently by the patient
Measured: 1 week postoperatively
Length of hospitalization
The length of hospitalization will be obtained from the Patient Chart.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start16 Jul 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Zingg, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120076
- Sponsor's protocol ID
- DEXA and PAO
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No If requested the individual participant data will be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy- a Double-blinded Placebo Controlled RCT
- ClinicalTrials.gov ID
- NCT05120076
- Acronym / sponsor ID
- DEXA and PAO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 15 Nov 2021 (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 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.
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 4 Mg/mL Injectable SolutionThe 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. 3ml of 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 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 4 Mg/mL Injectable SolutionAlso: 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 (worst 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 (worst possible pain).
Amount of opiates (morphinequivalent) consumed
Time frame: 48 hours postoperatively
The authors 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 hours postoperatively
The authors will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.
8 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 1
Time frame: 1 week postoperatively
Physical therapy milestones 2
Time frame: 1 week postoperatively
Physical therapy milestones 3
Time frame: 1 week postoperatively
Length of hospitalization
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No. 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
Study Principal Investigator
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 4 Mg/mL Injectable Solution and NaCl 0.9% in people with Pain and Postoperative Nausea, 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominik Kaiser, MD (+41443865764, dominik.kaiser@balgrist.ch), or a site near the patient. 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?
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 12 Aug 2024.