NCT03011905

Brief Summary

Many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. This study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The primary endpoint is difference in the highest pain score first 24 hours after surgery. The investigators will also look at pain scores and analgesics consumption first few hours after surgery and at different times up to 2 years after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2017

Typical duration for phase_3

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

December 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

2.3 years

First QC Date

December 21, 2016

Last Update Submit

September 18, 2020

Conditions

Brachial Plexus BlockPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Differences between groups in highest pain scores first 24 hours after surgery

    24 hours

Secondary Outcomes (13)

  • Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours

    30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours

  • Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks

    36 hours, 3 days, 7 days, 6 weeks

  • Differences in pain scores after 6 months and 1 year

    6 months and 1 year

  • Differences in analgesic consumption

    1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year

  • Differences in block duration

    20 hours

  • +8 more secondary outcomes

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.

Drug: DexamethasoneDrug: ParacetamolDrug: EtoriCoxibDrug: OxycodoneDrug: Ropivacaine

Control

PLACEBO COMPARATOR

Single dose of NaCl, 4 ml, iv during operation.

Drug: NaCl (Control)Drug: ParacetamolDrug: EtoriCoxibDrug: OxycodoneDrug: Ropivacaine

Interventions

DexamethasoneDRUG

4 ml DexaGalen 4 mg/ml

Also known as: DexaGalen
Dexamethasone
NaCl (Control)DRUG

4 ml NaCl 9 mg/ml

Also known as: NaCl
Control
ParacetamolDRUG

Premedication and as needed after operation

ControlDexamethasone
EtoriCoxibDRUG

Premedication and first 2 postoperative days.

Also known as: Arcoxia
ControlDexamethasone
OxycodoneDRUG

Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.

Also known as: OxyContin, OxyNorm
ControlDexamethasone
RopivacaineDRUG

In brachial plexus block

ControlDexamethasone

Eligibility Criteria

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

You may qualify if:

  • Distal radius fracture planned for operation with a volar plate
  • days after trauma
  • AO classification A, B, and C
  • ASA 1 and 2
  • Age 18-65
  • BMI 18-35
  • Able to communicate in Norwegian

You may not qualify if:

  • Chronic pain
  • Other injuries
  • Pregnancy
  • Known allergic reactions to medicines used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten

Oslo, 0540, Norway

Location

Related Publications (1)

  • Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30.

    PMID: 32472958DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexamethasoneAcetaminophenEtoricoxibOxycodoneRopivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic Hydrocarbons

Study Officials

  • Anne Holmberg, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 5, 2017

Study Start

January 1, 2017

Primary Completion

April 5, 2019

Study Completion

April 5, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)