NCT06789042

Brief Summary

Effect of adding Dexamethasone to Erector Spinae Plane Block in Patients undergoing Total Hip Arthroplasty

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2025

Completed
Last Updated

July 23, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

January 17, 2025

Last Update Submit

July 19, 2025

Conditions

Hip OsteoarthritisHip ArthropathyHip Arthritis

Keywords

erector spinae plane blocktotal hip arthroplastypain managementperineural adjuvant

Outcome Measures

Primary Outcomes (1)

  • Time to first rescue opioid analgesia

    Time after surgery when the patient needs opiate for the first time

    48 hours after surgery

Secondary Outcomes (17)

  • Total Opioid Consumption

    48 hours after procedure

  • Numerical Rating Scale [range 0:10]

    4 hours after surgery

  • Numerical Rating Scale [range 0:10]

    8 hours after surgery

  • Numerical Rating Scale [range 0:10]

    12 hours after surgery

  • Numerical Rating Scale [range 0:10]

    24 hours after surgery

  • +12 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Ultrasound-guided ESPB - 20ml 0,2% ropivacaine + 2ml 0.9% NaCl

Drug: 0.9%NaCl

Dexamethasone

ACTIVE COMPARATOR

Ultrasound-guided ESPB - 20ml 0,2% ropivacaine + 4mg Dexamethasone

Drug: Dexamethasone 4mg

Interventions

0.9%NaClDRUG

20ml 0.2% Ropivacaine + 2.0ml 0.9% NaCl

Control group
Dexamethasone 4mgDRUG

20ml 0.2% Ropivacaine + 4mg Dexamethasone

Dexamethasone

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for total hip arthroplasty
  • patients aged \>65 and \<100 years
  • patients able to provide informed consent
  • patients able to reliably report symptoms to the research team

You may not qualify if:

  • inability to provide first-party consent due to cognitive impairment or a language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Wielkopolska, 61-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, HipAgnosia

Interventions

Sodium ChlorideDexamethasone

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Malgorzata Resyner, MD PhD

    Poznań University of Medical Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

February 1, 2025

Primary Completion

July 15, 2025

Study Completion

July 18, 2025

Last Updated

July 23, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)