The effect of adrenocortical hormone on operation related pain in patients after the operation for dysplasia of the hip.

Phase 1

• Conditions: Dysplasia of the hip; MedDRA version: 20.0Level: LLTClassification code 10063175Term: Hip dysplasiaSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-000402-30-DK
• Lead Sponsor: Viktoria Lindberg-Larsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Patients undergoing periacetabular osteotomy due to symptomatic hip dysplasia (CE<25grader) or retroverted acetabulum (crossover and posterior wall sign)
2.= 18 years
3.Females if fertile*: Verified negative s-HCG, usage of safe contraceptives** or surgical sterilisation.
4.Patients who give their written informed consent to participating in the trial, after having fully understood the content of the protocol and restrictions.
*Postmenopausal is defined as >12months amenorrhoea.
**Safe contraceptives accepted: intrauterine device or hormone contraceptives.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Patients who cannot speak or understand Danish
2.Allergy or contraindications to trial medication
3.Spinal anaesthesia
4.Second intervention carried out simultaneously (e.g. femur osteotomy)
5.Patients with daily opioid consumption prior to surgery (tramadol and codeine accepted)
6.Drug, medical abuse or weekly alcohol consumption beyond =7 (female) and =14 (men) units, respectively.
7.Mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants)
8.Diabetes diagnosed prior to inclusion
9.Immune suppression therapy (e.g. systemic glucocorticoids)
10.Kidney impairment (eGFR < 50ml/min) or liver disease (=Child Pugh B)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified