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RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

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ClinicalTrials.gov Identifier: NCT02152514
Recruitment Status : Terminated (Due to technical details recruitment was unreasonably slow)
First Posted : June 2, 2014
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Yanick Sansoucy, 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.

Condition or disease Intervention/treatment Phase
Thoracic Surgery, Video-assisted Postoperative Pain Rachianesthesia Sufentanil Morphine Drug: Intrathecal Morphine/Sufentanil Device: PCA Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Comparing Post-VATS Analgesia Between Patients With an Intrathecal Injection of Morphine and Sufentanil Versus Placebo.
Study Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Patient Controlled Analgesia




Primary Outcome Measures :
  1. Hydromorphone consommation [ Time Frame: 24hr ]
    The amount of Hydromorphone needed by the patient in the first 24hr after his VATS.


Secondary Outcome Measures :
  1. Pain [ Time Frame: Every 4h x 24hr ]
    A VAS will be used.

  2. Adverse effects of narcotics [ Time Frame: 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]

  3. Adverse reactions associate with rachianesthesia [ Time Frame: 24hr ]

    Including :

    • Backache
    • Headache
    • Legs strength

  4. Adverse reactions of narcotics [ Time Frame: 24hr ]

    Including :

    • Nausea
    • Pruritis
    • Urinary retention



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152514


Locations
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Canada, Quebec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
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Principal Investigator: Yanick Sansoucy Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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Responsible Party: Yanick Sansoucy, Anesthesiologist, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02152514     History of Changes
Other Study ID Numbers: Epimorph for VATS
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Sufentanil
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics