Local Infiltration Analgesia in Total Knee Arthroplasty
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2015
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedJuly 2, 2017
June 1, 2017
6 months
June 28, 2017
June 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Morphine consumption
24 hours
Secondary Outcomes (4)
NRS scores
24 hours
Complications
24 hours
Patient satisfaction
24 hours
Duration of hospitalization
1 month
Study Arms (2)
LIA
ACTIVE COMPARATORLocal infiltration analgesia
sham LIA
SHAM COMPARATORSaline injections
Interventions
Eligibility Criteria
You may qualify if:
- Physical status according to American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total knee arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tziona D, Papaioannou M, Mela A, Potamianou S, Makris A. Local infiltration analgesia combined with a standardized multimodal approach including an adductor canal block in total knee arthroplasty: a prospective randomized, placebo-controlled, double-blinded clinical trial. J Anesth. 2018 Jun;32(3):326-332. doi: 10.1007/s00540-018-2476-x. Epub 2018 Mar 5.
PMID: 29508066DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Anaesthesiologist
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 2, 2017
Study Start
September 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
July 2, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share