Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy

Phase 3

Completed

• Conditions: Opioid Use; Pain, Postoperative; Nausea, Postoperative
• Interventions: Drug: Dexamethasone 4mg; Drug: NaCl 0.9%

• Registration Number: NCT04610398
• Lead Sponsor: Balgrist University Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-30
• Study Start: 2021-03-11
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone group	Dexamethasone 4mg	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.
Placebo/ Control group	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain level	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	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)	48 houts postoperatively	We will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.

Secondary Outcome Measures

Name	Time	Method
Length of hospitalization	after 1 week	The length of hospitalization will be obtained from the Patient Chart.
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire	48 hours postoperatively	Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).
Number of vomiting events	48 hours postoperatively	We will Count the number of vomiting Events postoperatively as a direct marker for postoperative Nausea.
Physical therapy milestones	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)

Trial Locations

Locations (1)

Uniklinik Balgrist; 🇨🇭 Zürich, Switzerland