NCT03513276

Brief Summary

Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by optimal pain management protocols. Multimodal analgesia protocols including local infiltration anesthesia (LIA) have obtained excellent results in fast-track programs involving Total Knee Arthroplasty but further research and data is needed in Total Hip Arthoplasty programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2016

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

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

February 26, 2018

Last Update Submit

April 29, 2018

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain measured in Visual Analog Scale

    Pain assesed using Visual Analog Scale ( Scoring from 0 to 10)

    Up to 48h postoperatively

Secondary Outcomes (3)

  • Length of hospital stay

    Up to 1 week

  • Analgesic requirements

    Up to 1 week

  • Complications

    Up to 1 week

Study Arms (2)

Multimodal analgesia + Local Infiltration Anesthesia

EXPERIMENTAL

100cc of 2% ropivacaine + Adrenaline 10mcg/ml + 20cc saline solution

Drug: 100cc of 2% ropivacaineDrug: Adrenaline 10mcg/ml

Multimodal analgesia + saline solution

ACTIVE COMPARATOR

120cc of saline solution

Drug: Saline Solution

Interventions

100cc of 2% ropivacaineDRUG

Multimodal analgesia + Local infiltration anesthesia

Multimodal analgesia + Local Infiltration Anesthesia
Saline SolutionDRUG

Multimodal analgesia + Saline solution

Multimodal analgesia + saline solution
Adrenaline 10mcg/mlDRUG
Multimodal analgesia + Local Infiltration Anesthesia

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hip osteoarthritis requiring Total Hip Replacement

You may not qualify if:

  • Mental Disorders
  • contraindications for epidural anesthesia
  • Neurologic disorders that could interfere with pain evaluation
  • allergy to drugs in multimodal analgesic protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Related Publications (1)

  • Bernaus M, Novellas M, Bartra A, Nunez JH, Angles F. Local infiltration analgesia does not have benefits in fast-track hip arthroplasty programmes: a double-blind, randomised, placebo-controlled, clinical trial. Hip Int. 2022 Nov;32(6):711-716. doi: 10.1177/1120700021992684. Epub 2021 Feb 18.

    PMID: 33601948DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

RopivacaineSaline SolutionEpinephrine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 26, 2018

First Posted

May 1, 2018

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

ES(1)