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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03704831
Other study ID # RECHMPL18_0304
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 20, 2018
Est. completion date November 30, 2019

Study information

Verified date March 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this retrospective study is to compare the analgesic efficiency of IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) with surgical infiltration after total knee arthroplasty. The main objective is to compare cumulative morphine consumption the first 24 hours after surgery. The secondary objectives are to compare pain scores, types and amounts of other analgesics needed during the first 24 hours after surgery.


Description:

After patient agreement, data will be collected on patient records and will be compared into 2 groups.

Data will be :

- cumulative consumption of morphine during the first 24 hours after surgery

- pain scores during the first 24 hours after surgery

- amount of analgesics during the first 24 hours after surgery

- maximal pain score during the first 24 hours after surgery


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 30, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion criteria:

- All adults patients after a total knee arthroplasty since november 2015

Exclusion criteria:

- Child, non primitive surgery

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block
Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee)
Injection of local anesthetics during total knee arthroplasty by surgical infiltration
Injection of local anesthetics during total knee arthroplasty by surgical infiltration.

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analgesic need Morphine consumption during the first 24 hours after total knee arthroplasty 24 hours
Secondary Pain scores in the recovery room Pain scores in the recovery room during the first 24 hours after surgery using the EVA scale 24 hours
Secondary maximal pain score maximal pain score during the first 24 hours after surgery using the EVA scale 24 hours
Secondary Description of the analgesics administered types of other analgesics needed during the first 24 hours after surgery 24 hours
Secondary amount other analgesics amount other analgesics needed during the first 24 hours after surgery 24 hours
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