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

Postoperative Pain Clinical Trial

— AMBUPRESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03205189
• Other study ID #: 2015/119/SC
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2017
• Last updated: July 10, 2017
• Start date: May 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2017
• Source: University Hospital, Rouen
• Contact: Vincent COMPERE
• Phone: 023288
• Email: vincent.compere[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Surgery
• Anesthesia
• Pain, Postoperative
• Postoperative Complication
• Postoperative Complications
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence to analgesic treatment	Adherence to analgesic treatment in relation to prescription (yes or not)	Within 7 days after ambulatory surgery
Secondary	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
Secondary	Use of morphine analgesics	Incidence of morphine analgesic use	Within 7 days after ambulatory surgery