RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

Study Overview
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Brief Summary
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The purpose of the study is to determine if the administration of a mix of Sufentanil and Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.

Detailed Description
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This study will compare the need for analgesia (Hydromorphone PCA) of two groups of patients post-VATS. The placebo group will only have a PCA for post-operative analgesia, witch is the standard care for patient post-VATS. The experimental group will have a intrathecal injection of a mix of morphine and sufentanil before the induction of anesthesia.

Official Title
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Randomized Controlled Trial Comparing Post-VATS Analgesia Between Patients With an Intrathecal Injection of Morphine and Sufentanil Versus Placebo.

Conditions
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Thoracic Surgery, Video-assisted, Postoperative Pain, Rachianesthesia, Sufentanil, Morphine

Intervention / Treatment
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* Drug: Intrathecal Morphine/Sufentanil
* Device: PCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: VATS ASA 1,2 or 3 Minimum weight of 50 kg Patient able to consent Exclusion Criteria: Patient refusal Patient unable to understand PCA Contraindication to rachianalgesia Zona Pregnancy Over 30 mg of morphine during the last 24 hours Use of Pregabalin, Gabapentin, Doluxetin, Amitriptyline or NSAI in a context of chronic pain Severe allergic reaction to morphine, hydromorphone, sufentanil or local anesthetic Intubation over 1 hour after surgery (unability to use PCA) High risk of conversion to thoracotomy Unable to perform rachianalgesia due to technical difficulties

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrathecal Morphine/Sufentanil and PCA<br>Patients will receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will have a PCA for analgesia rescue in the post-operative period. | Drug: Intrathecal Morphine/Sufentanil<br> <br> Device: PCA<br> <br> * Other names: Patient Controlled Analgesia;|
| Placebo Comparator: PCA alone<br>Patients will NOT receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will only have a PCA for analgesia in the post-operative period. | Device: PCA<br> <br> * Other names: Patient Controlled Analgesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydromorphone consommation | The amount of Hydromorphone needed by the patient in the first 24hr after his VATS. | 24hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | A VAS will be used. | Every 4h x 24hr | 
| Adverse effects of narcotics | Including : Saturation [Saturation (%) and the need for oxygen (l/min) will be assess to evaluate the incidence of desaturation and hypoventilation in both arms] Sedation [Sedation will be evaluate with the Riker Sedation Agitation Scale] Respiratory rate [To evaluate the incidence of hypoventilation (<8/min) and to compare the average between both arms] | Every 4h x 24hr | 
| Adverse reactions associate with rachianesthesia | Including : Backache Headache Legs strength | 24hr | 
| Adverse reactions of narcotics | Including : Nausea Pruritis Urinary retention | 24hr |