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Clinical Trials/NCT03513276
NCT03513276CompletedPhase 4

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

Hospital Mutua de Terrassa1 site in 1 country63 target enrollmentStarted: February 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
63
Locations
1
Primary Endpoint
Pain measured in Visual Analog Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
20 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Multimodal analgesia + Local Infiltration Anesthesia

Experimental

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

Intervention: 100cc of 2% ropivacaine (Drug)

Multimodal analgesia + Local Infiltration Anesthesia

Experimental

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

Intervention: Adrenaline 10mcg/ml (Drug)

Multimodal analgesia + saline solution

Active Comparator

120cc of saline solution

Intervention: Saline Solution (Drug)

Outcomes

Primary Outcomes

Pain measured in Visual Analog Scale

Time Frame: Up to 48h postoperatively

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

Secondary Outcomes

  • Length of hospital stay(Up to 1 week)
  • Analgesic requirements(Up to 1 week)
  • Complications(Up to 1 week)

Investigators

Sponsor
Hospital Mutua de Terrassa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

fangles

Medical Doctor

Hospital Mutua de Terrassa

Study Sites (1)

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