Back to resultsThoracolumbar Interfascial Plane Block Versus Bilateral Erector Spinae Plane Block In Lumbar Laminectomy
Primary Purpose
Postoperative Pain, Lumbar Laminectomy, Thoracolumbar Interfascial Plane Block
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracolumbar Interfascial Plane Block (TLIP)
Bilateral Erector Spinae plane Block (ESB)
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Seventy cases with herniated lumbar disc scheduled for lumbar single-level or multiple-level lumbar discectomy with American Society of Anesthesiologists physical status (ASA) I or II aged between 21 and 60 years of both genders.
Exclusion Criteria:
- Body mass index >32
- History of relevant allergy to any of the drugs used in the procedure
- Previous lumbar spine surgery or back surgery with planed spinal fixation
Sites / Locations
- Tanta University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Thoracolumbar Interfascial Plane Block (TLIP)
Bilateral Erector Spinae plane Block (ESB)
Arm Description
Outcomes
Primary Outcome Measures
Degree of pain by visual Analog Scale (VAS) score at rest
Pain scores will be observed and recorded using the Visual Analog Scale (VAS) both at rest and during movement. The scores will be recorded in the ward at 2, 4, 8, 12, and 24 h.
VAS score from 0 to 10 (0: No pain, 10: The worst pain)
Secondary Outcome Measures
Degree of pain by visual Analog Scale (VAS) score at movement
Pain scores will be observed and recorded using the Visual Analog Scale (VAS) both at rest and during movement. The scores will be recorded in the ward at 2, 4, 8, 12, and 24 h VAS score from 0 to 10 (0: No pain, 10: The worst pain)
Total rescue analgesics consumption
The time to first analgesic
24-h morphine consumption
Side effects associated with morphine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04757480
Brief Title
Thoracolumbar Interfascial Plane Block Versus Bilateral Erector Spinae Plane Block In Lumbar Laminectomy
Official Title
Ultrasound Guided Thoracolumbar Interfascial Plane Block Versus Bilateral Ultrasound Guided Erector Spinae Plane Block for Post-Operative Pain Management In Lumbar Laminectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
October 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this prospective randomized trial is to compare the efficacy ultrasound guided thoracolumbar interfascial plane block versus bilateral ultrasound guided erector spinae plane block for post-operative pain management after lumbar laminectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Lumbar Laminectomy, Thoracolumbar Interfascial Plane Block, Erector Spinae Plane Block, Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thoracolumbar Interfascial Plane Block (TLIP)
Arm Type
Experimental
Arm Title
Bilateral Erector Spinae plane Block (ESB)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Thoracolumbar Interfascial Plane Block (TLIP)
Intervention Description
(20ml) (plain bupivacaine 0.25% on each side toward the LG-MF interface.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Erector Spinae plane Block (ESB)
Intervention Description
Will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the eighth thoracic segment (T8).
Primary Outcome Measure Information:
Title
Degree of pain by visual Analog Scale (VAS) score at rest
Description
Pain scores will be observed and recorded using the Visual Analog Scale (VAS) both at rest and during movement. The scores will be recorded in the ward at 2, 4, 8, 12, and 24 h.
VAS score from 0 to 10 (0: No pain, 10: The worst pain)
Time Frame
First 24 hours postoperative
Secondary Outcome Measure Information:
Title
Degree of pain by visual Analog Scale (VAS) score at movement
Description
Pain scores will be observed and recorded using the Visual Analog Scale (VAS) both at rest and during movement. The scores will be recorded in the ward at 2, 4, 8, 12, and 24 h VAS score from 0 to 10 (0: No pain, 10: The worst pain)
Time Frame
First 24 hours postoperative
Title
Total rescue analgesics consumption
Time Frame
First 24 hours postoperative
Title
The time to first analgesic
Time Frame
First 24 hours postoperative
Title
24-h morphine consumption
Time Frame
First 24 hours postoperative
Title
Side effects associated with morphine
Time Frame
First 24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Seventy cases with herniated lumbar disc scheduled for lumbar single-level or multiple-level lumbar discectomy with American Society of Anesthesiologists physical status (ASA) I or II aged between 21 and 60 years of both genders.
Exclusion Criteria:
Body mass index >32
History of relevant allergy to any of the drugs used in the procedure
Previous lumbar spine surgery or back surgery with planed spinal fixation
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
ElGharbiaa
ZIP/Postal Code
31511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliaa M Abdel kader
Phone
01021559948
Email
aliaa.hasanin@gmail.com
Phone
00201000629011
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available with reasonalble consent
Learn more about this trial
Thoracolumbar Interfascial Plane Block Versus Bilateral Erector Spinae Plane Block In Lumbar Laminectomy
We'll reach out to this number within 24 hrs