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RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

Primary Purpose

Thoracic Surgery, Video-assisted, Postoperative Pain, Rachianesthesia

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Intrathecal Morphine/Sufentanil
PCA
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thoracic Surgery, Video-assisted

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre hospitalier universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intrathecal Morphine/Sufentanil and PCA

PCA alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain
A VAS will be used.
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]
Adverse reactions associate with rachianesthesia
Including : Backache Headache Legs strength
Adverse reactions of narcotics
Including : Nausea Pruritis Urinary retention

Full Information

First Posted
May 23, 2014
Last Updated
January 18, 2016
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT02152514
Brief Title
RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo
Official Title
Randomized Controlled Trial Comparing Post-VATS Analgesia Between Patients With an Intrathecal Injection of Morphine and Sufentanil Versus Placebo.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Due to technical details recruitment was unreasonably slow
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery, Video-assisted, Postoperative Pain, Rachianesthesia, Sufentanil, Morphine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrathecal Morphine/Sufentanil and PCA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PCA alone
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intrathecal Morphine/Sufentanil
Intervention Type
Device
Intervention Name(s)
PCA
Other Intervention Name(s)
Patient Controlled Analgesia
Primary Outcome Measure Information:
Title
Hydromorphone consommation
Description
The amount of Hydromorphone needed by the patient in the first 24hr after his VATS.
Time Frame
24hr
Secondary Outcome Measure Information:
Title
Pain
Description
A VAS will be used.
Time Frame
Every 4h x 24hr
Title
Adverse effects of narcotics
Description
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]
Time Frame
Every 4h x 24hr
Title
Adverse reactions associate with rachianesthesia
Description
Including : Backache Headache Legs strength
Time Frame
24hr
Title
Adverse reactions of narcotics
Description
Including : Nausea Pruritis Urinary retention
Time Frame
24hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanick Sansoucy
Organizational Affiliation
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada

12. IPD Sharing Statement

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RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

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