Clinical trial NCT03205189: Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription
Official title: Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription: a Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Ambulatory Surgery
Anesthesia
Postoperative Complication
Keywords: postoperative pain
ambulatory surgery
general anesthesia
anesthesia consultation
post-op prescription
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, prospective, study
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Early home pain after ambulatory surgery
timeFrame: 24 hours after ambulatory surgery
Secondary outcomes:
measure: Intense painful experience during hospitalisation
timeFrame: Day 1
measure: Low painful experience during hospitalisation
timeFrame: Day 1
measure: Low home pain experience
timeFrame: 24 hours after ambulatory surgery
measure: Intense home pain experience
timeFrame: Within 7 days after ambulatory surgery
measure: Low home pain experience
timeFrame: Within 7 days after ambulatory surgery
measure: Adherence to analgesic treatment
timeFrame: Within 7 days after ambulatory surgery
measure: Patient's satisfaction
timeFrame: Within 7 days after ambulatory surgery
measure: Use of morphine analgesics
timeFrame: Within 7 days after ambulatory surgery
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Vincent COMPERE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.