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
About this trial
This is an interventional prevention trial for Thoracic Surgery, Video-assisted
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
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
NCT ID
NCT02152514
First Posted
May 23, 2014
Last Updated
January 18, 2016
Sponsor
Université de Sherbrooke
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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