NCT05120076

Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy

Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy- a Double-blinded Placebo Controlled RCT

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Balgrist University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Dexamethasone 4 Mg/mL Injectable Solution	s. arm/group description
DRUG	NaCl 0.9%	s. arm/group description

Timeline

• Start date: 2021-07-16
• Primary completion: 2024-07-31
• Completion: 2024-08-31
• First posted: 2021-11-15
• Last updated: 2024-08-12

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated drug study