Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription

NCT ID: NCT03205189

Last Updated: 2017-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the comparison of the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia preoperative clinic and a group with postoperative prescription.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ambulatory surgery increased over the last twenty years in France. The management of home pain after ambulatory surgery is a major challenge because it is the principal complication after day surgery with several consequences: nausea and vomiting, chronic pain, functional impairment with handicap, sleeping troubles, extra-hospital consultation. Management of home pain remains currently could be performed in ambulatory surgery. The French Society of Anesthesiology recommends to deliver pre-surgical prescription during the preoperative anesthesia clinic but this guideline is not bases on evidence in the literature. Also, we have previously shown in a retrospective non-randomized work a decrease of postoperative home pain in patient with general anesthesia. The main objective of this controlled and comparative study is to compare the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia consultation and a group with postoperative prescription.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Ambulatory Surgery Anesthesia Postoperative Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, prospective, study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre-operative prescription group

This group will have a pre-operative prescription delivered during the preoperative anesthesia clinic.

Group Type OTHER

Comparison between pre-operative prescription and post-operative prescription

Intervention Type OTHER

The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.

Postoperative prescription group

This group will receive the postoperative prescription.

Group Type OTHER

Comparison between pre-operative prescription and post-operative prescription

Intervention Type OTHER

The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Comparison between pre-operative prescription and post-operative prescription

The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any major ambulatory surgery patient with general anesthesia.

Exclusion Criteria

* Pregnancy.
* Minor patient.
* ASA score \> 3.
* lack of general anesthesia.
* General anesthesia combined with locoregional anesthesia.
* Contraindication to ambulatory surgery.
* Chronic pain.
* chronic analgesic consumption.
* no indication of non steroidal anti-inflammatory drug, paracetamol with codeine and morphine.
* Active or old drug addiction.
* Cognitive disorders or dementia.
* Serious psychiatric disorders.
* Patient under curatorship or tutorship.
* No social protection
* Misunderstanding of the French language
* Patient participating in another trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vincent COMPERE, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rouen University Hospital

Rouen, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vincent COMPERE

Role: CONTACT

023288 ext. 8990

Julien BLOT

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vincent COMPERE, Pr

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Selim J, Djerada Z, Chaventre C, Clavier T, Dureuil B, Besnier E, Compere V. Preoperative analgesic instruction and prescription reduces early home pain after outpatient surgery: a randomized controlled trial. Can J Anaesth. 2022 Aug;69(8):1033-1041. doi: 10.1007/s12630-021-02023-0. Epub 2021 May 13.

Reference Type DERIVED
PMID: 33982238 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015/119/SC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preoperative IV Versus Oral Acetaminophen
NCT03468920 COMPLETED PHASE4
Postoperative and Opioid Free Anesthesia
NCT03316339 TERMINATED PHASE3
Scheduled or As Needed Pain Regimen?
NCT06495632 RECRUITING PHASE4
Pilot Trial: Postoperative Opioid-free Analgesia
NCT04254679 COMPLETED PHASE2/PHASE3