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

Primary Purpose

Hip Osteoarthritis

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

100cc of 2% ropivacaine

Saline Solution

Adrenaline 10mcg/ml

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Universitari Mutua Terrassa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal analgesia + Local Infiltration Anesthesia

Multimodal analgesia + saline solution

Arm Description

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

120cc of saline solution

Outcomes

Primary Outcome Measures

Pain measured in Visual Analog Scale

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

Secondary Outcome Measures

Length of hospital stay

Length of hospital stay measured in days

Analgesic requirements

Analgesia requirements needed besides protocol medication Measured in miligrams of drug required(Sevredol) Analgesia required by patient

Complications

Wound dehiscence, Infection, reoperation, dislocation.

Full Information

NCT ID

NCT03513276

First Posted

February 26, 2018

Last Updated

April 29, 2018

Sponsor

Hospital Mutua de Terrassa

1. Study Identification

Unique Protocol Identification Number

NCT03513276

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Mutua de Terrassa

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multimodal analgesia + Local Infiltration Anesthesia

Arm Type

Experimental

Arm Description

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

Arm Title

Multimodal analgesia + saline solution

Arm Type

Active Comparator

Arm Description

120cc of saline solution

Intervention Type

Drug

Intervention Name(s)

100cc of 2% ropivacaine

Intervention Description

Multimodal analgesia + Local infiltration anesthesia

Intervention Type

Drug

Intervention Name(s)

Saline Solution

Intervention Description

Multimodal analgesia + Saline solution

Intervention Type

Drug

Intervention Name(s)

Adrenaline 10mcg/ml

Primary Outcome Measure Information:

Title

Pain measured in Visual Analog Scale

Description

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

Time Frame

Up to 48h postoperatively

Secondary Outcome Measure Information:

Title

Length of hospital stay

Description

Length of hospital stay measured in days

Time Frame

Up to 1 week

Title

Analgesic requirements

Description

Analgesia requirements needed besides protocol medication Measured in miligrams of drug required(Sevredol) Analgesia required by patient

Time Frame

Up to 1 week

Title

Complications

Description

Wound dehiscence, Infection, reoperation, dislocation.

Time Frame

Up to 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hospital Universitari Mutua Terrassa

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08221

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

33601948

Citation

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.

Results Reference

derived

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

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