Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy

Pain, Postoperative Clinical Trial

Official title:

Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy- a Double-blinded Placebo Controlled RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610398
• Other study ID #: DEXA and HAS
• Status: Completed
• Phase: Phase 3
• Start date: March 11, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Nausea
• Nausea, Postoperative
• Opioid Use
• Pain, Postoperative
• Postoperative Nausea and Vomiting

Intervention

Drug:
• Dexamethasone 4mg
s. arm/group description
• NaCl 0.9%
s. arm/group description

Locations

Country	Name	City	State
Switzerland	Uniklinik Balgrist	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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).	6 hours postoperatively
Secondary	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).	24 hours postoperatively
Secondary	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).	48 hours postoperatively
Secondary	Number of vomiting events	We will Count the number of vomiting Events postoperatively as a direct marker for postoperative Nausea.	48 hours postoperatively
Secondary	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)	48 hours postoperatively
Secondary	Length of hospitalization	The length of hospitalization will be obtained from the Patient Chart.	after 1 week