Local Infiltration Analgesia in Total Knee Arthroplasty

Phase 2

Completed

• Conditions: Total Knee Arthroplasty; Analgesia
• Interventions: Other: Saline; Drug: Ropivacaine

• Registration Number: NCT03206554
• Lead Sponsor: Asklepieion Voulas General Hospital

Brief Summary

40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group LIA (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be administered. All patients received a standardized multimodal approach, including pregabalin, adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with morphine. Morphine consumption during the first 24 hours postoperatively was measured and additionally the investigators recorded: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours postoperatively, complications, patient satisfaction and duration of hospitalization.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-06
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-30
• Last Update Submitted: 2017-06-30
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Physical status according to American Society of Anesthesiologists (ASA) I-III
• Patients scheduled for total knee arthroplasty

Exclusion Criteria

• Contraindication for central and/or peripheral nervous blockade
• Reoperation on previous total knee arthroplasty
• History of allergic or other adverse reactions on the agents used in the study
• Chronic opioid or gabapentinoid use
• Serious psychiatric, mental and cognitive disorders
• Language barrier
• Difficulty in understanding or using a patient controlled analgesia device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham LIA	Saline	Saline injections
LIA	Ropivacaine	Local infiltration analgesia

Primary Outcome Measures

Name	Time	Method
Morphine consumption	24 hours

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization	1 month	Number of days patients remain in the hospital postoperatively
NRS scores	24 hours
Complications	24 hours
Patient satisfaction	24 hours	Patients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No