Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.

April 29, 2018 updated by: fangles, Hospital Mutua de Terrassa
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitari Mutua Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hip osteoarthritis requiring Total Hip Replacement

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Multimodal analgesia + Local Infiltration Anesthesia
100cc of 2% ropivacaine + Adrenaline 10mcg/ml + 20cc saline solution
Drug: 100cc of 2% ropivacaine
Multimodal analgesia + Local infiltration anesthesia
Drug: Adrenaline 10mcg/ml
ACTIVE_COMPARATOR: Multimodal analgesia + saline solution
120cc of saline solution
Drug: Saline Solution
Multimodal analgesia + Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measured in Visual Analog Scale
Time Frame: Up to 48h postoperatively
Pain assesed using Visual Analog Scale ( Scoring from 0 to 10)
Up to 48h postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Up to 1 week
Length of hospital stay measured in days
Up to 1 week
Analgesic requirements
Time Frame: Up to 1 week
Analgesia requirements needed besides protocol medication Measured in miligrams of drug required(Sevredol) Analgesia required by patient
Up to 1 week
Complications
Time Frame: Up to 1 week
Wound dehiscence, Infection, reoperation, dislocation.
Up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Mutua de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

April 29, 2018

First Posted (ACTUAL)

May 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 29, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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