Local Infiltration Analgesia in Total Knee Arthroplasty

Asklepieion Voulas General Hospital

Status and phase: Completed; Phase 2

Conditions: Analgesia; Total Knee Arthroplasty

Treatments: Other: Saline; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03206554

511/25/09/2015

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups

LIA

Active Comparator group

Description:

Local infiltration analgesia

Treatment:

Drug: Ropivacaine

sham LIA

Sham Comparator group

Description:

Saline injections

Treatment:

Other: Saline