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

Not Applicable

• Conditions: Postoperative Pain; Ambulatory Surgery; Anesthesia; Postoperative Complication
• Interventions: Other: Comparison between pre-operative prescription and post-operative prescription

• Registration Number: NCT03205189
• Lead Sponsor: University Hospital, Rouen

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.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-28
• Status Verified: 2017-07
• Study First Posted: 2017-07-02
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-13
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-operative prescription group	Comparison between pre-operative prescription and post-operative prescription	This group will have a pre-operative prescription delivered during the preoperative anesthesia clinic.
Postoperative prescription group	Comparison between pre-operative prescription and post-operative prescription	This group will receive the postoperative prescription.

Primary Outcome Measures

Name	Time	Method
Early home pain after ambulatory surgery	24 hours 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France