Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy

NCT04610398 | Completed Phase 3 FDA Drug

• 1 other identifier: DEXA and HAS
• 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 hip arthroscopy.

Conditions

Pain, Postoperative; Nausea, Postoperative; Opioid Use

Outcome Measures

Primary Outcomes (4)

• Postoperative pain level

  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

  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

  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)

  We will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.

  48 houts postoperatively

Secondary Outcomes (6)

• 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

  48 hours 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 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.

Drug: NaCl 0.9%

Interventions

Dexamethasone 4mg 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+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Location

Related Publications (1)

• 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.

  PMID: 38456291 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; 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

  PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 30, 2020
• Study Start: March 11, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)