Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy

Balgrist University Hospital60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain, Postoperative Nausea, Postoperative Opioid Use

Interventions

Dexamethasone 4mgDRUG

s. arm/group description

NaCl 0.9%DRUG

s. arm/group description

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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"

Locations (1)

Uniklinik Balgrist

Zurich, Switzerland

Outcomes

Primary Outcomes

Postoperative pain level

The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).

Time frame: 6 hours postoperatively

Postoperative pain level

The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).

Time frame: 24 hours postoperatively

Amount of opiates (morphinequivalent) consumed

We will assess the amount of Opiates the Patient needed due to the performed Surgery during the hospital stay.

Time frame: 48 hours postoperatively

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.

Time frame: 48 houts postoperatively

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Data from ClinicalTrials.gov

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