NCT03704831

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

October 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

September 24, 2018

Last Update Submit

March 9, 2020

Conditions

Total Knee Arthroplasty

Keywords

Locoregional anesthesiaIPACK blocksurgical infiltrationTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Analgesic need

    Morphine consumption during the first 24 hours after total knee arthroplasty

    24 hours

Secondary Outcomes (4)

  • Pain scores in the recovery room

    24 hours

  • maximal pain score

    24 hours

  • Description of the analgesics administered

    24 hours

  • amount other analgesics

    24 hours

Study Arms (2)

IPACK group

IPACK group

Other: Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block

Surgical infiltration group

Surgical infiltration group

Other: Injection of local anesthetics during total knee arthroplasty by surgical infiltration

Interventions

Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK blockOTHER

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)

IPACK group
Injection of local anesthetics during total knee arthroplasty by surgical infiltrationOTHER

Injection of local anesthetics during total knee arthroplasty by surgical infiltration.

Surgical infiltration group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults patients after a total knee arthroplasty

You may qualify if:

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

You may not qualify if:

  • \- Child, non primitive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

  • Xavier Capdevila, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

October 15, 2018

Study Start

October 20, 2018

Primary Completion

November 1, 2019

Study Completion

November 30, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

FR(1)