NCT06832995

Brief Summary

Despite the use of multimodal analgesia combining nerve block (NB) and systemic analgesia, intravenous (IV) morphine titration in the post-anesthetic care unit (PACU) after total hip (THA) and knee (TKA) arthroplasty is required to relieve early moderate-to-severe pain. Sedation occurrence during titration and a VAS score higher than 60/100mm are two independent risk factors for postoperative pain during hospitalization. The association of NB and multimodal analgesia constitutes the reference in evidence-based recommendations. An adductor or femoral triangle block, alone or associated with periarticular infiltration, is recommended during TKA. During THA, NB associated with surgical periarticular infiltration improves analgesia and rehabilitation This study aims to identify the incidence and risk factors of morphine titration in PACU after lower limb arthroplasty performed by 5 experienced surgeons and using a multimodal analgesic procedure

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

February 12, 2025

Last Update Submit

February 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • morphine titration

    after surgery, in the post-anesthetic care unit

Study Arms (2)

group T: IV morphine administered during the PACU stay

Drug: IV morphine administered during the PACU stay

group NT: no titration required in PACU

Interventions

IV morphine administered during the PACU stay

group T: IV morphine administered during the PACU stay

Eligibility Criteria

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

Each patient who underwent unilateral knee, total knee and total hip arthroplasty at the Sévigné Private Hospital between January 1, 2023, and December 31, 2023.

You may qualify if:

  • Total hip arthroplasty
  • Total Knee Arthroplasty
  • Uni-compartmental knee arthroplasty (UKA)

You may not qualify if:

  • Bilateral surgery Surgical revision Hip fracture surgery Other osteoarticular procedure(s) associated to hip/knee arthroplasty Refusal to use data Contra-indication of paracetamol, ketoprofen and dexamethasone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Sévigné

Cesson-Sévigné, 35051, France

Location

Study Design

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

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 18, 2025

Study Start

April 1, 2024

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations