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

Primary Purpose

Postoperative Pain, Ambulatory Surgery, Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Comparison between pre-operative prescription and post-operative prescription
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring postoperative pain, ambulatory surgery, general anesthesia, anesthesia consultation, post-op prescription

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Pre-operative prescription group

Postoperative prescription group

Arm Description

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

This group will receive the postoperative prescription.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.
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
Adherence to analgesic treatment
Adherence to analgesic treatment in relation to prescription (yes or not)
Patient's satisfaction
Patient's satisfaction with prescribed treatment (scale from 0 to 10, satisfying opinion defined by a score greater than 8)
Use of morphine analgesics
Incidence of morphine analgesic use

Full Information

First Posted
June 15, 2017
Last Updated
July 10, 2017
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT03205189
Brief Title
Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription
Acronym
AMBUPRESS
Official Title
Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription: a Randomized Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Ambulatory Surgery, Anesthesia, Postoperative Complication
Keywords
postoperative pain, ambulatory surgery, general anesthesia, anesthesia consultation, post-op prescription

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, prospective, study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-operative prescription group
Arm Type
Other
Arm Description
This group will have a pre-operative prescription delivered during the preoperative anesthesia clinic.
Arm Title
Postoperative prescription group
Arm Type
Other
Arm Description
This group will receive the postoperative prescription.
Intervention Type
Other
Intervention Name(s)
Comparison between pre-operative prescription and post-operative prescription
Intervention Description
The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.
Primary Outcome Measure Information:
Title
Early home pain after ambulatory surgery
Description
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.
Time Frame
24 hours after ambulatory surgery
Secondary Outcome Measure Information:
Title
Intense painful experience during hospitalisation
Description
Incidence of a pain experience at mobilization or at rest of intensity greater than 3 on a scale from 0 to 10 during hospitalisation.
Time Frame
Day 1
Title
Low painful experience during hospitalisation
Description
Incidence of a pain experience at mobilization or at rest of intensity lower than 3 on a scale from 0 to 10 during hospitalisation.
Time Frame
Day 1
Title
Low home pain experience
Description
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
Time Frame
24 hours after ambulatory surgery
Title
Intense home pain experience
Description
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.
Time Frame
Within 7 days after ambulatory surgery
Title
Low home pain experience
Description
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
Time Frame
Within 7 days after ambulatory surgery
Title
Adherence to analgesic treatment
Description
Adherence to analgesic treatment in relation to prescription (yes or not)
Time Frame
Within 7 days after ambulatory surgery
Title
Patient's satisfaction
Description
Patient's satisfaction with prescribed treatment (scale from 0 to 10, satisfying opinion defined by a score greater than 8)
Time Frame
Within 7 days after ambulatory surgery
Title
Use of morphine analgesics
Description
Incidence of morphine analgesic use
Time Frame
Within 7 days after ambulatory surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent COMPERE
Phone
023288
Ext
8990
Email
vincent.compere@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent COMPERE, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent COMPERE, Pr
Email
vincent.compere@chu-rouen.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33982238
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.
Results Reference
derived

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

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