Evaluation of the Effectiveness of an Accelerated Rehabilitation Protocol Based on Multimodal Analgesia Optimization for Uni-compartmental Knee Prosthesis Surgery

NCT04916158 | Unknown

• 1 other identifier: 29BRC20.0324
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Today, prosthetic replacement for osteoarthritis of the knee is a frequent surgery. In France, nearly 100,000 knee arthroplasties are performed each year . Over the last two decades, there has been growing interest in performing single compartment knee replacement (SKR) surgery in patients with isolated single compartment osteoarthritis. The explanation lies in faster recovery, less postoperative pain and less morbidity compared to total knee arthroplasty (TKR) . Pain control is one of the major elements of outpatient management of CKD . Prosthetic knee surgery is very painful, the median pain is rated at 5 out of 10 and on average we use 32 milligrams of morphine . The efficiency of the adductor canal block is effective in this context, it avoids the motor block obtained by the femoral block, therefore interesting for ambulatory management in view of a resumption of the fast walking foreseen for the patient. The IPACK (interspace between popliteal artery and the capsule posterior knee) is designed to block the small sensory branches of the sciatic nerve that pass through this space without affecting the motor components. The IPACK block provides analgesia only for the posterior knee and would probably be ineffective alone for postoperative analgesia It is therefore often performed with an adductor canal block for multimodal analgesia. This block is performed in several facilities, and data are increasingly emerging on its effectiveness . Thus, based on the recommendations of the French Society of Anesthesia and Resuscitation, on improved rehabilitation after heavy orthopedic surgery on the lower limb published in 2019 the objective of this study is to evaluate the relevance of a protocol concerning prosthetic knee replacement (PUC) in ambulatory care, based on optimized pain control.

Conditions

Anesthesia

Keywords

IPACK, knee arthroplasty, ambulatory

Outcome Measures

Primary Outcomes (1)

• Test get up and go test measured from day 0 to day 3. The test is successful if the score is >1

  Day 0 to Day 3

Secondary Outcomes (3)

• evaluation of the patient's recovery by the QOR-15 questionnaire at 24 and 48 hours,

  24 and 48 hours

• evaluation of visual analogue pain scale up to Day 5 postoperatively

  day 5

• evaluation of morphine consumption up to Day 5 postoperatively

  day 5

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with programmed SKR

You may qualify if:

• Patients with programmed SKR,
• \>18 and \< 85 years of age,
• Score ASA 1-2,
• No cognitive impairment,
• No thromboembolic TCDA,
• Without CI to local anesthetics, analgesics,
• Accepting outpatient care
• No opposition formulated

You may not qualify if:

• \<18 years and \>85 years
• Patients under legal protection (guardianship, curatorship, ...)
• Refusal to participate
• Support for a total knee prosthesis,
• Emergency surgery or revision surgery,
• ASA3-4,
• SAOS not fitted,
• Allergy or hypersensitivity to local anesthetics,
• Outpatient discharge criteria not met.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Central Study Contacts

Quentin HERBEL

CONTACT

0618136736; quentinherbel@gmail.com

Claire-Marine Grayo, Doctorat

CONTACT

claire-marine.grayo@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: June 7, 2021
• Study Start: January 7, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)