Local Infiltration Analgesia in Total Knee Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Total Knee Arthroplasty
• Intervention / Treatment: Drug: Ropivacaine; Other: Saline

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LIA; Local infiltration analgesia	Drug: Ropivacaine; Large volume local anaesthetic intraarticularly
Sham Comparator: sham LIA; Saline injections	Other: Saline; sham injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morphine consumption	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asklepieion Voulas General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 511/25/09/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No