RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

Phase 4

Terminated

• Conditions: Morphine; Thoracic Surgery, Video-assisted; Rachianesthesia; Postoperative Pain; Sufentanil
• Interventions: Drug: Intrathecal Morphine/Sufentanil; Device: PCA

• Registration Number: NCT02152514
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-02
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal Morphine/Sufentanil and PCA	Intrathecal Morphine/Sufentanil	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.
PCA alone	PCA	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.
Intrathecal Morphine/Sufentanil and PCA	PCA	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.

Primary Outcome Measures

Name	Time	Method
Hydromorphone consommation	24hr	The amount of Hydromorphone needed by the patient in the first 24hr after his VATS.

Secondary Outcome Measures

Name	Time	Method
Adverse reactions of narcotics	24hr	Including : * Nausea; * Pruritis; * Urinary retention
Adverse effects of narcotics	Every 4h x 24hr	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 \[To evaluate the incidence of hypoventilation (\<8/min) and to compare the average between both arms\]
Pain	Every 4h x 24hr	A VAS will be used.
Adverse reactions associate with rachianesthesia	24hr	Including : * Backache; * Headache; * Legs strength

Trial Locations

Locations (1)

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada