Local Infiltration Analgesia in Total Knee Arthroplasty
Primary Purpose
Total Knee Arthroplasty, Analgesia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Total Knee Arthroplasty
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
LIA
sham LIA
Arm Description
Local infiltration analgesia
Saline injections
Outcomes
Primary Outcome Measures
Morphine consumption
Secondary Outcome Measures
NRS scores
Complications
Patient satisfaction
Patients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No
Duration of hospitalization
Number of days patients remain in the hospital postoperatively
Full Information
NCT ID
NCT03206554
First Posted
June 28, 2017
Last Updated
June 30, 2017
Sponsor
Asklepieion Voulas General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03206554
Brief Title
Local Infiltration Analgesia in Total Knee Arthroplasty
Official Title
Local Infiltration Analgesia in Total Knee Arthroplasty: A Randomized, Prospective, Placebo Controlled, Double Blinded Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asklepieion Voulas General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIA
Arm Type
Active Comparator
Arm Description
Local infiltration analgesia
Arm Title
sham LIA
Arm Type
Sham Comparator
Arm Description
Saline injections
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Large volume local anaesthetic intraarticularly
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
sham injection
Primary Outcome Measure Information:
Title
Morphine consumption
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
NRS scores
Time Frame
24 hours
Title
Complications
Time Frame
24 hours
Title
Patient satisfaction
Description
Patients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No
Time Frame
24 hours
Title
Duration of hospitalization
Description
Number of days patients remain in the hospital postoperatively
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29508066
Citation
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.
Results Reference
derived
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Local Infiltration Analgesia in Total Knee Arthroplasty
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