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NCT03513276 Clinical Trial

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

Hip Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03513276
Other study ID # 00002
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2016
Est. completion date February 2018

Study information
Verified date April 2018
Source Hospital Mutua de Terrassa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• 100cc of 2% ropivacaine
Multimodal analgesia + Local infiltration anesthesia
• Saline Solution
Multimodal analgesia + Saline solution
• Adrenaline 10mcg/ml

Locations
Country Name City State
Spain Hospital Universitari Mutua Terrassa Terrassa Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Mutua de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain measured in Visual Analog Scale Pain assesed using Visual Analog Scale ( Scoring from 0 to 10) Up to 48h postoperatively
Secondary Length of hospital stay Length of hospital stay measured in days Up to 1 week
Secondary Analgesic requirements Analgesia requirements needed besides protocol medication Measured in miligrams of drug required(Sevredol) Analgesia required by patient Up to 1 week
Secondary Complications Wound dehiscence, Infection, reoperation, dislocation. Up to 1 week
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