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

Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription: a Randomized Prospective Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Anesthesia; Postoperative Complication; Ambulatory Surgery
• Intervention / Treatment: Other: Comparison between pre-operative prescription and post-operative prescription

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pre-operative prescription group; This group will have a pre-operative prescription delivered during the preoperative anesthesia clinic.	Other: 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.
Other: Postoperative prescription group; This group will receive the postoperative prescription.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early home pain after ambulatory surgery	The primary outcome is the incidence of at least one home pain experience with intensity greater than 3 on a scale from 0 to 10 within 24 hours after surgery.	24 hours after ambulatory surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intense painful experience during hospitalisation	Incidence of a pain experience at mobilization or at rest of intensity greater than 3 on a scale from 0 to 10 during hospitalisation.	Day 1
Low painful experience during hospitalisation	Incidence of a pain experience at mobilization or at rest of intensity lower than 3 on a scale from 0 to 10 during hospitalisation.	Day 1
Low home pain experience	Incidence of a pain experience at mobilization or at rest of intensity lower than 3 at home on a scale from 0 to 10 within 24 hours after surgery	24 hours after ambulatory surgery
Intense home pain experience	Incidence of home pain at mobilization or at rest of intensity greater than 3 on a scale from 0 to 10 within 7 days after surgery.	Within 7 days after ambulatory surgery
Low home pain experience	Incidence of home pain at mobilization or at rest of intensity lower than 3 at home on a scale from 0 to 10 within 7 days after surgery	Within 7 days after ambulatory surgery
Adherence to analgesic treatment	Adherence to analgesic treatment in relation to prescription (yes or not)	Within 7 days after ambulatory surgery
Patient's satisfaction	Patient's satisfaction with prescribed treatment (scale from 0 to 10, satisfying opinion defined by a score greater than 8)	Within 7 days after ambulatory surgery
Use of morphine analgesics	Incidence of morphine analgesic use	Within 7 days after ambulatory surgery

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Vincent COMPERE, Pr, University Hospital, Rouen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: general anesthesia; postoperative pain; ambulatory surgery; anesthesia consultation; post-op prescription
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Postoperative Complications
• Other Study ID Numbers: 2015/119/SC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No