Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block
Primary Purpose
Post Operative Pain, Analgesia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
retrolaminar block
ESPB
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria: Age18-60. Both genders. hepatobiliary surgery. ASA I-III. Exclusion Criteria: Drug allergy. Morbid obesity (BMI >40 kg/m2). Psychiatric disorder. Opiod dependence.
Sites / Locations
- Minia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Retrolaminar plane block
ESPB
Arm Description
Outcomes
Primary Outcome Measures
Visual analogue pain scale
score from 0-10 (0 mean no pain and 10 the worst pain )
Secondary Outcome Measures
Time of first post operative analgesic request.
time to demand rescue analgesia
Total analgesic consumption
total fentanyl consumption during the first day postoperative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05705739
Brief Title
Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block
Official Title
Comparison Between the Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block for Postoperative Pain in Patients Undergoing Hepatobiliary Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia 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
Retrolaminar block (RLB) and erector spinae plane block (ESPB) are alternative approaches to paravertebral block (PVB) and are advantageous in that they are easier and safer techniques compared with the traditional PVB. These blocks are considered to be compartment blocks or interfascial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space.
the study aim to evaluate and compare the analgesic efficacy of retrolaminar plane block and erector spinae plane block.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retrolaminar plane block
Arm Type
Experimental
Arm Title
ESPB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
retrolaminar block
Intervention Description
curved probe will be placed 1-1.5 cm lateral to the target spinous process after identification of the lamina, the needle will be advanced caudally until it contacts the lamina
Intervention Type
Procedure
Intervention Name(s)
ESPB
Intervention Description
curved probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle.
Primary Outcome Measure Information:
Title
Visual analogue pain scale
Description
score from 0-10 (0 mean no pain and 10 the worst pain )
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Time of first post operative analgesic request.
Description
time to demand rescue analgesia
Time Frame
24 hour
Title
Total analgesic consumption
Description
total fentanyl consumption during the first day postoperative
Time Frame
24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age18-60.
Both genders.
hepatobiliary surgery.
ASA I-III.
Exclusion Criteria:
Drug allergy.
Morbid obesity (BMI >40 kg/m2).
Psychiatric disorder.
Opiod dependence.
Facility Information:
Facility Name
Minia University
City
Minya
State/Province
Minia
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block
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