A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery

Postoperative Pain Clinical Trial

Official title:

A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06268587
• Other study ID #: 2023/80
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1423
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• outpatient surgery

• no age limit

• accepted post-operative monitoring by text messages (SMS)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Outpatient Surgery
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège	Wallonie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	Measure the impact of the protocol on the occurrence of nausea and vomiting on day one	The patients receive a text message (SMS) on day 1 asking for their pain level between 1 and 10. The patients receive a text message (SMS) on day 1 asking if they suffer from nausea and vomiting. If the answer is no, they respond 0 to the SMS. If the answer is yes, they answer 1.; In the event of no response to the SMS or the présence nausea and vomiting, they are contacted by telephone.	day 1
Secondary	Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction	The patients receive a text message (SMS) on day 7 to know their satisfaction. A Visual Analogue Scale Satisfaction is used. A Visual Analogue Scale Satisfaction = 0: the worst experience. A Visual Analogue Scale Satisfaction = 10: the best experience	day 7