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

Phase 4

Completed

• Conditions: Hip Osteoarthritis
• Interventions: Drug: Saline Solution; Drug: 100cc of 2% ropivacaine; Drug: Adrenaline 10mcg/ml

• Registration Number: NCT03513276
• Lead Sponsor: Hospital Mutua de Terrassa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Study First Submitted: 2018-02-26
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-29
• Last Update Submitted: 2018-04-29
• Study First Posted: 2018-05-01
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal analgesia + saline solution	Saline Solution	120cc of saline solution
Multimodal analgesia + Local Infiltration Anesthesia	100cc of 2% ropivacaine	100cc of 2% ropivacaine + Adrenaline 10mcg/ml + 20cc saline solution
Multimodal analgesia + Local Infiltration Anesthesia	Adrenaline 10mcg/ml	100cc of 2% ropivacaine + Adrenaline 10mcg/ml + 20cc saline solution

Primary Outcome Measures

Name	Time	Method
Pain measured in Visual Analog Scale	Up to 48h postoperatively	Pain assesed using Visual Analog Scale ( Scoring from 0 to 10)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitari Mutua Terrassa; 🇪🇸 Terrassa, Barcelona, Spain