Back to resultsEfficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Erector spinae plane block
No injection
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for thoracoscopy
- physical status I-III
Exclusion Criteria:
- allergy to local anaesthetics
- other contraindications to peripheral nerve blocks
- patients suffering from chronic pain condition
Sites / Locations
- Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of LausanneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Erector spinae plane block
Placebo
Arm Description
Outcomes
Primary Outcome Measures
IV morphine consumption
mg
Secondary Outcome Measures
IV morphine consumption
mg
IV morphine consumption
mg
Pain scores
Visual analog scale, 0-10
Chronic pain scores
Visual analog scale, 0-10
Forced vital capacity
L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03454191
Brief Title
Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy
Official Title
Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric Albrecht
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erector spinae plane block
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
Injection of local anaesthetics below the erector spinae muscle after induction of anaesthesia
Intervention Type
Procedure
Intervention Name(s)
No injection
Intervention Description
No injection
Primary Outcome Measure Information:
Title
IV morphine consumption
Description
mg
Time Frame
24 postoperative hours
Secondary Outcome Measure Information:
Title
IV morphine consumption
Description
mg
Time Frame
2 postoperative hours
Title
IV morphine consumption
Description
mg
Time Frame
48 postoperative hours
Title
Pain scores
Description
Visual analog scale, 0-10
Time Frame
2, 24, 24 postoperative hours
Title
Chronic pain scores
Description
Visual analog scale, 0-10
Time Frame
3 and 6 postoperative months
Title
Forced vital capacity
Description
L
Time Frame
24 and 48 postoperative hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for thoracoscopy
physical status I-III
Exclusion Criteria:
allergy to local anaesthetics
other contraindications to peripheral nerve blocks
patients suffering from chronic pain condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Albrecht, PD- MER
Phone
+41 79 556 63 41
Email
eric.albrecht@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Albrecht, PD-MER
Phone
+41 79 556 63 41
Email
eric.albrecht@chuv.ch
Facility Information:
Facility Name
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, MD
Phone
+41795566341
Email
eric.albrecht@chuv.ch
First Name & Middle Initial & Last Name & Degree
Magnus Oloffson, MD
Phone
+41795563809
Email
magnus.oloffson@chuv.ch
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy
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