RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intrathecal Morphine/Sufentanil and 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.	Drug: Intrathecal Morphine/Sufentanil; Device: PCA; Other Names: Patient Controlled Analgesia
Placebo Comparator: PCA alone; 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; Other Names: Patient Controlled Analgesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Yanick Sansoucy, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 23, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 18, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Morphine; Sufentanil
• Other Study ID Numbers: Epimorph for VATS