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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03206554
Other study ID # 511/25/09/2015
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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