NCT06268587

Brief Summary

The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is: \- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics. The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

December 26, 2023

Last Update Submit

February 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measure the impact of the protocol on the proportion of patients with a pain greater than 3/10 on a Visual Analogue Scale at day one and who did not take the analgesics.

    Visual Analogue Scale = 0/10 : no pain Visual Analogue Scale = 10/10: maximal pain The patients receive a text message (SMS) on day 1 asking for their pain level between 1 and 10. They send the response via SMS. If the response is greater than 3/10, an SMS asks patients if they have taken their painkillers. If they took them, they say "taken". Otherwise, they are invited to take them and are contacted again 45 minutes later for a new evaluation. In the event of no response to the SMS or pain \> 3/10 despite taking the prescribed painkillers, they are contacted by telephone.

    day 1

Secondary Outcomes (3)

  • Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group

    day 1

  • Measure the impact of the protocol on the occurrence of nausea and vomiting on day one

    day 1

  • Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction

    day 7

Study Arms (2)

control group

The control group is made up of patients, without age limit, who underwent an outpatient surgery from 01/09/19 to 28/02/20 inclusive and accepted post-operative monitoring by SMS. These patients leaves the hospital with instructions and prescriptions.

experimental group

The experimental group is made up of patients, without age limit, who underwent an outpatient surgery procedure from 1/9/21 to 28/2/22 inclusive and accepted post-operative monitoring by SMS. The patients leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain.

Combination Product: Measure the impact of the home analgesia protocol on the proportion of patients with a VAS &amp;gt; 3/10 on day one and who did not take analgesics.

Interventions

Measure the impact of the home analgesia protocol on the proportion of patients with a VAS \&amp;gt; 3/10 on D+1 and who did not take analgesics. The protocol consists of providing the patient with instructions at the time of discharge, analgesics for a maximum of two days with dosages and an explanatory booklet on pain management

experimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent outpatient surgery at the Liège university hospital center in Belgium

You may qualify if:

  • outpatient surgery
  • no age limit
  • accepted post-operative monitoring by text messages (SMS)

You may not qualify if:

  • refusal of post-operative follow-up by text messages (SMS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liège

Liège, Wallonia, 4000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

argipressin, Asu(1,6)-

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 26, 2023

First Posted

February 20, 2024

Study Start

September 1, 2019

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations