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

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

Study Overview

• Status: Recruiting
• Conditions: Pain; Postoperative Nausea; Amount of Postoperative Opioid Use in Milligrams
• Intervention / Treatment: Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: NaCl 0.9%

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dominik Kaiser, MD; Phone Number: +41443865764; Email: dominik.kaiser@balgrist.ch
• Study Contact Backup: Name: Sabrina Catanzaro, study nurse; Phone Number: +41443867370; Email: sabrina.catanzaro@balgrist.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Recruiting
    • Uniklinik Balgrist
    • Contact: Dominik Kaiser; Phone Number: +41443865764; Email: dominik.kaiser@balgrist.ch
    • Contact: Patrickt Zingg; Email: patrick.zingg@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone group; 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 4 Mg/mL Injectable Solution; s. arm/group description; Other Names: Fortecortin Inject (Merck (Switzerland))
Placebo Comparator: Placebo/ Control group; 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.	Drug: NaCl 0.9%; s. arm/group description; Other Names: NaCL Braun (B Braun medical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain level	The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain).	6 hours postoperatively
Postoperative pain level	The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain).	24 hours postoperatively
Amount of opiates (morphinequivalent) consumed	The authors 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)	The authors will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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). (0% worst, 100% best)	6 hours postoperatively
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).(0% worst, 100% best)	24 hours postoperatively
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).(0% worst, 100% best)	48 hours postoperatively
Number of vomiting events	The authors will count the number of vomiting events postoperatively as a direct marker for postoperative Nausea.	48 hours postoperatively
Physical therapy milestones 1	First steps in the hallway	1 week postoperatively
Physical therapy milestones 2	Walk up stairs	1 week postoperatively
Physical therapy milestones 3	Bicycle ergometer can be used indipendently by the patient	1 week postoperatively
Length of hospitalization	The length of hospitalization will be obtained from the Patient Chart.	2 weeks

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Patrick Zingg, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Vomiting; Pain, Postoperative; Nausea; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Dexamethasone acetate
• Other Study ID Numbers: DEXA and PAO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No If requested the individual participant data will be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes