Dual Injection ESPB Versus Single Injection ESPB for Laparotomies
Primary Purpose
Post Operative Pain, Regional Block
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
single level
dual level
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain focused on measuring ESPB, pain, regional block
Eligibility Criteria
Inclusion Criteria: Age18-60. Both genders. abdominal surgery. ASA I-III. Exclusion Criteria: Drug allergy. Morbid obesity (BMI >40 kg/m2). Psychiatric disorder. Opiod dependence. patient refuse.
Sites / Locations
- Minia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
single ESPB
dual ESB
Arm Description
single injection at level T8
dual injection at level T7 and T9
Outcomes
Primary Outcome Measures
first analgesic request
time to request fentanyl
Secondary Outcome Measures
resting visual analogue pain scale
pain score at rest from 0-10 which 0 mean no pain and 10 the worst pain
dynamic visual analogue pain scale
pain score at movement (cough) from 0-10 which 0 mean no pain and 10 the worst pain
analgesic consumption
total fentanyl required first day postoperative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05633329
Brief Title
Dual Injection ESPB Versus Single Injection ESPB for Laparotomies
Official Title
Comparison Between the Efficacy of Ultrasound Guided Single Injection Erector Spinae Plane Block Versus Dual Injection Erector Spinae Plane Block for Postoperative Pain in Patients Undergoing Abdominal Surgery: Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
June 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Regional Block
Keywords
ESPB, pain, regional block
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single ESPB
Arm Type
Experimental
Arm Description
single injection at level T8
Arm Title
dual ESB
Arm Type
Experimental
Arm Description
dual injection at level T7 and T9
Intervention Type
Procedure
Intervention Name(s)
single level
Intervention Description
injection of 40 ml bupivacaine 0.25 at T8 (20 ml on each side)
Intervention Type
Procedure
Intervention Name(s)
dual level
Intervention Description
injection of 40 ml of bupivacaine 0.25 at two level T7 and T9 (10 ml on each level of both side)
Primary Outcome Measure Information:
Title
first analgesic request
Description
time to request fentanyl
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
resting visual analogue pain scale
Description
pain score at rest from 0-10 which 0 mean no pain and 10 the worst pain
Time Frame
24 hours
Title
dynamic visual analogue pain scale
Description
pain score at movement (cough) from 0-10 which 0 mean no pain and 10 the worst pain
Time Frame
24 hours
Title
analgesic consumption
Description
total fentanyl required first day postoperative
Time Frame
24 hours
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.
abdominal surgery.
ASA I-III.
Exclusion Criteria:
Drug allergy.
Morbid obesity (BMI >40 kg/m2).
Psychiatric disorder.
Opiod dependence.
patient refuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hassan m. hetta, lecturer
Organizational Affiliation
minia university/ faculty of medicine
Official's Role
Principal Investigator
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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Dual Injection ESPB Versus Single Injection ESPB for Laparotomies
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