Back to resultsErector Spinae Plane Block After Lumbar Spinal Stenosis Surgery
Primary Purpose
Lumbar Spinal Stenosis, Erector Spinae Plane Block
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ESPB
Local infiltration by the surgeon
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis
Eligibility Criteria
Inclusion Criteria:
- Any lumbar spinae surgery on 2 or more lumbar levels
Exclusion Criteria:
- Contraindication to NSAID
- Allergy to any local anesthetics
Sites / Locations
- Clinique Saint PierreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Erector Spinae plane Block (ESPB) group
Local anesthesia infiltration by the surgeon
Arm Description
The ultrasound-guided ESPB was realized at T12 level (levo bupivacaine 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)after the induction of anesthesia but before the start of the surgery.
The surgeon infiltrates the surgical site after skin incision with local anesthetics (Levo Bupivacaïne 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)
Outcomes
Primary Outcome Measures
Total 24 h Piritramide consumption
Total consumption of Piritramide consumption after surgery
Secondary Outcome Measures
Quebec back pain disability scale (QBPDS)
A questionnaire developed to measure the level of functional disability for patients with low back pain
Full Information
NCT ID
NCT04403360
First Posted
May 21, 2020
Last Updated
May 21, 2020
Sponsor
Clinique Saint Pierre Ottignies
1. Study Identification
Unique Protocol Identification Number
NCT04403360
Brief Title
Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery
Official Title
Impact of the Erector Spinae Plane Block on the Postoperative Pain After Lumbar Spinal Stenosis Surgery: Single Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique Saint Pierre Ottignies
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
Lumbar spinae stenosis surgery is a frequent intervention resulting in important postoperative pain. Management of this postoperative pain is thus important. Different pain management therapies exist. The erector spinae plane (ESP) block was described in 2016. It involves the injection of local anesthetics into the interfascial plane, deep to erector spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Erector Spinae Plane Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erector Spinae plane Block (ESPB) group
Arm Type
Experimental
Arm Description
The ultrasound-guided ESPB was realized at T12 level (levo bupivacaine 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)after the induction of anesthesia but before the start of the surgery.
Arm Title
Local anesthesia infiltration by the surgeon
Arm Type
Active Comparator
Arm Description
The surgeon infiltrates the surgical site after skin incision with local anesthetics (Levo Bupivacaïne 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)
Intervention Type
Procedure
Intervention Name(s)
ESPB
Intervention Description
Ultrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery
Intervention Type
Procedure
Intervention Name(s)
Local infiltration by the surgeon
Intervention Description
Local infiltration of anesthetics at surgical site after skin incision
Primary Outcome Measure Information:
Title
Total 24 h Piritramide consumption
Description
Total consumption of Piritramide consumption after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Quebec back pain disability scale (QBPDS)
Description
A questionnaire developed to measure the level of functional disability for patients with low back pain
Time Frame
At 2 months]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Any lumbar spinae surgery on 2 or more lumbar levels
Exclusion Criteria:
Contraindication to NSAID
Allergy to any local anesthetics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georges SAMOURI, MD
Phone
003210437260
Email
georges.samouri@cspo.be
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas PARISI, MD
Phone
003210437608
Email
nicolas.parisi@cspo.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges SAMOURI, MD
Organizational Affiliation
Clinique Saint Pierre Ottignies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Saint Pierre
City
Ottignies
State/Province
Brabant Wallon
ZIP/Postal Code
1340
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges SAMOURI, MD
Phone
003210437260
Email
georges.samouri@cspo.be
First Name & Middle Initial & Last Name & Degree
Nicolas PARISI, MD
Phone
003210437608
Email
nicolas.parisi@cspo.be
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data will be presented in future manuscripts.
Citations:
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
result
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Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery
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