Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy

Balgrist University Hospital

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: NaCl 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT05120076

DEXA and PAO

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Dexamethasone group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone 4 Mg/mL Injectable Solution

Placebo/ Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: NaCl 0.9%