Comparison of Analgesic Efficiency Between IPACK Block and Surgical Infiltration After Total Knee Arthroplasty (IPACK)

March 9, 2020 updated by: University Hospital, Montpellier

Comparison of Analgesic Efficiency Between IPACK Block (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) and Surgical Infiltration After Total Knee Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adults patients after a total knee arthroplasty

Description

Inclusion criteria:

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

Exclusion criteria:

- Child, non primitive surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IPACK group
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)
Surgical infiltration group
Other: Injection of local anesthetics during total knee arthroplasty by surgical infiltration
Injection of local anesthetics during total knee arthroplasty by surgical infiltration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic need
Time Frame: 24 hours
Morphine consumption during the first 24 hours after total knee arthroplasty
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores in the recovery room
Time Frame: 24 hours
Pain scores in the recovery room during the first 24 hours after surgery using the EVA scale
24 hours
maximal pain score
Time Frame: 24 hours
maximal pain score during the first 24 hours after surgery using the EVA scale
24 hours
Description of the analgesics administered
Time Frame: 24 hours
types of other analgesics needed during the first 24 hours after surgery
24 hours
amount other analgesics
Time Frame: 24 hours
amount other analgesics needed during the first 24 hours after surgery
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Xavier Capdevila, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 20, 2018

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

November 30, 2019

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (ACTUAL)

October 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL18_0304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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