Local Infiltration Analgesia in Total Knee Arthroplasty

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206554
• Other study ID #: 511/25/09/2015
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2017
• Last updated: June 30, 2017
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2017
• Source: Asklepieion Voulas General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Total Knee Arthroplasty

Intervention

Drug:
• Ropivacaine
Large volume local anaesthetic intraarticularly

Other:
• Saline
sham injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asklepieion Voulas General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption		24 hours
Secondary	NRS scores		24 hours
Secondary	Complications		24 hours
Secondary	Patient satisfaction	Patients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No	24 hours
Secondary	Duration of hospitalization	Number of days patients remain in the hospital postoperatively	1 month