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Local Infiltration Analgesia in Total Knee Arthroplasty

Local Infiltration Analgesia in Total Knee Arthroplasty: A Randomized, Prospective, Placebo Controlled, Double Blinded Study.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03206554
Enrollment
40
Registered
2017-07-02
Start date
2015-09-30
Completion date
2016-03-31
Last updated
2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Total Knee Arthroplasty

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.

Interventions

DRUGRopivacaine

Large volume local anaesthetic intraarticularly

OTHERSaline

sham injection

Sponsors

Asklepieion Voulas General Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Morphine consumption24 hours

Secondary

MeasureTime frameDescription
NRS scores24 hours
Complications24 hours
Patient satisfaction24 hoursPatients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No
Duration of hospitalization1 monthNumber of days patients remain in the hospital postoperatively

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026