NCT03332316

Brief Summary

Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_4 postoperative-pain

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

October 26, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

November 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

6.1 years

First QC Date

October 26, 2017

Last Update Submit

November 22, 2023

Conditions

Postoperative PainNerve Block

Outcome Measures

Primary Outcomes (1)

  • First need of opiate

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

    48 hours

Secondary Outcomes (4)

  • Opiate consumption

    48 hours

  • Pain

    postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 28 hours, 32 hours, at 36 hours, at 40 hours, at 44 hours, at 48 hours,seventh postoperative day

  • Mobilisation

    postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 28 hours, 32 hours, at 36 hours, at 40 hours, at 44 hours, at 48 hours

  • Blood glucose

    postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours

Other Outcomes (2)

  • Quality of life (EQ-5D-3L) -query

    Before operation and 6-8 weeks, 6 months, 12 months postoperatively

  • McGill -pain query

    Before operation and 6-8 weeks, 6 months, 12 months postoperatively

Study Arms (4)

DEXA0

PLACEBO COMPARATOR

Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally

Drug: Ropivacaine Hydrochloride Inj 2 mg/mlDrug: Sodium Chloride 9mg/mL

DEXA1

EXPERIMENTAL

Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,2 ml and Sodium Chloride 9mg/mL 0,8 ml perineurally

Drug: Dexamethasone Sodium PhosphateDrug: Ropivacaine Hydrochloride Inj 2 mg/mlDrug: Sodium Chloride 9mg/mL

DEXA2

EXPERIMENTAL

Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,4 ml and Sodium Chloride 9mg/mL 0,6 ml perineurally

Drug: Dexamethasone Sodium PhosphateDrug: Ropivacaine Hydrochloride Inj 2 mg/mlDrug: Sodium Chloride 9mg/mL

DEXA4

EXPERIMENTAL

Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,8 ml and Sodium Chloride 9mg/mL 0,2 ml perineurally

Drug: Dexamethasone Sodium PhosphateDrug: Ropivacaine Hydrochloride Inj 2 mg/mlDrug: Sodium Chloride 9mg/mL

Interventions

Dexamethasone Sodium PhosphateDRUG

Dexamethasone injection

Also known as: Oradexon
DEXA1DEXA2DEXA4
Ropivacaine Hydrochloride Inj 2 mg/mlDRUG

Ropivacaine injection

DEXA0DEXA1DEXA2DEXA4
Sodium Chloride 9mg/mLDRUG

Sodium Chloride injection

Also known as: Saline
DEXA0DEXA1DEXA2DEXA4

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult people under ankle/foot arthrodesis as a curative therapy of ankle arthrosis or situation after ankle injury or malposition

You may not qualify if:

  • Age under 18 years Complicated diabetes mellitus Lack of finnish language skill and/or co-operation Chronic pain Steroid medication in regular use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

dexamethasone 21-phosphateDexamethasoneSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Maija-Liisa Kalliomäki, PhD

    Tampere University Hospital

    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

October 26, 2017

First Posted

November 6, 2017

Study Start

November 2, 2017

Primary Completion

November 21, 2023

Study Completion

November 21, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)