Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy

NCT05120076 | Recruiting Phase 3 FDA Drug

• 1 other identifier: DEXA and PAO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Postoperative Nausea; Amount of Postoperative Opioid Use in Milligrams

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (8)

• Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire

  6 hours postoperatively

• Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire

  24 hours postoperatively

• Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire

  48 hours postoperatively

• Number of vomiting events

  48 hours postoperatively

• Physical therapy milestones 1

  1 week postoperatively

Study Arms (2)

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.

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.

Drug: NaCl 0.9%

Interventions

Dexamethasone 4 Mg/mL Injectable Solution DRUG

s. arm/group description

Also known as: Fortecortin Inject (Merck (Switzerland))

Dexamethasone group

NaCl 0.9% DRUG

s. arm/group description

Also known as: NaCL Braun (B Braun medical)

Placebo/ Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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"

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Uniklinik Balgrist

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Pain; Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Patrick Zingg, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Kaiser, MD

CONTACT

+41443865764; dominik.kaiser@balgrist.ch

Sabrina Catanzaro, study nurse

CONTACT

+41443867370; sabrina.catanzaro@balgrist.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Only the investigators as well as the head of anasthesiology will be informed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: November 15, 2021
• Study Start: July 16, 2021
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)