NCT02436694

Brief Summary

Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and sciatic nerve block improve analgesia postoperatively in patients submitted to total knee arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the local anaesthetic in a SSFNB and SSSNB in reducing pain scores, assessed by VAS. Outcome measures: Mean pain scores in both groups. Secondary aims: Evaluate opioid consumption in the postoperative period (8- 12h, 24h, 48h) and assess incidence of side effects and complications (numbness, paraesthesias, weakness, site infection, haematoma and falls).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

April 1, 2015

Last Update Submit

November 25, 2015

Conditions

Nerve Block

Keywords

DexamethasonePerineural

Outcome Measures

Primary Outcomes (1)

  • Quantification of Pain by VAS

    Pain assessed by VAS

    48 hours

Secondary Outcomes (3)

  • Morphine consumption in mg

    48 hours

  • Side-effects (numbness, paraesthesias, weakness, site infection, haematoma and falls)

    48 hours

  • Complications from technique (Motor ou sensitive changes, infection, nausea)

    48 hours

Study Arms (2)

Local Anesthetic ropivacaíne

ACTIVE COMPARATOR

Femoral nerve block with ropivacaine 0.375% and sciatic nerve block with ropivacaine 0.2%

Drug: Local Anesthetic ropivacaíne

Perineural Dexamethasone

EXPERIMENTAL

Femoral nerve block with ropivacaine 0.375% and perineural dexamethasone and sciatic nerve block with ropivacaine 0.2% and perineural dexamethasone

Drug: Local Anesthetic ropivacaíneDrug: Perineural Dexamethasone

Interventions

Local Anesthetic ropivacaíneDRUG

Femoral and sciatic nerve block with ropivacaíne

Also known as: Nerve block with local anesthetic
Local Anesthetic ropivacaínePerineural Dexamethasone
Perineural DexamethasoneDRUG

Addition of perineural dexamethasone to local anesthetic for femoral and sciatic nerve block

Also known as: Nerve block with local anesthetic and dexamethasone
Perineural Dexamethasone

Eligibility Criteria

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

You may qualify if:

  • Adult patients admitted foi unilaterla total knee arthroplasty

You may not qualify if:

  • Refusal/Incapacity to give informed consent
  • Contra-indication to general anesthesia
  • Infection at needle insertion site
  • Coagulation disorders
  • Pre-existing neurologic disorders
  • Known allergy to any of the drugs from the protocol
  • ASA status \>3
  • Weight\<50kg
  • BMI\>40
  • Inability to understand or use VAS pain score

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar do Porto

Porto, Porto District, 4099-001, Portugal

RECRUITING

MeSH Terms

Interventions

Nerve BlockAnesthetics, LocalDexamethasone

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Raul carvalho, MD

    Centro Hospitalar do Porto

    STUDY DIRECTOR

Central Study Contacts

Marta M Carvalho, MD

CONTACT

00351 912948973marta.monteiro.carvalho@gmail.com

Silvia AB Pinho, MD

CONTACT

00351914619787silviaabpinho@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 1, 2015

First Posted

May 7, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations

PT(1)