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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain, Ambulatory Surgery, Anesthesia, Postoperative Complication

Intervention / Treatment
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* Other: Comparison between pre-operative prescription and post-operative prescription


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, prospective, study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pre-operative prescription group<br>This group will have a pre-operative prescription delivered during the preoperative anesthesia clinic. | Other: Comparison between pre-operative prescription and post-operative prescription<br>* The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.<br>|
| Other: Postoperative prescription group<br>This group will receive the postoperative prescription. | Other: Comparison between pre-operative prescription and post-operative prescription<br>* The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, ambulatory surgery, general anesthesia, anesthesia consultation, post-op prescription