Back to resultsUltrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
erector spinea block
Caudal epidural block
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- ASA I-II.
- Scheduled to undergo hip or proximal femur surgeries.
Exclusion Criteria:
- Refusal of participation by parents or caregivers
- Known local anesthetic (LA) drug sensitivity
- Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3.
- Skin lesions or wounds at the site of proposed needle insertion.
Sites / Locations
- Kasr Alaini hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group ESPB
In group CEA
Arm Description
Erector Spinae Plane Block
Caudal epidural block
Outcomes
Primary Outcome Measures
Pain score
By using face, legs, activity, and cry consolability scale [FLACC ]
FLACC scale will be measured as following:
Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10.
Assessment of the final score:
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Secondary Outcome Measures
pain scores
By using face, legs, activity, and cry consolability scale [FLACC ]
FLACC scale will be measured as following:
Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10.
Assessment of the final score:
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Block failure rate
The block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively
Block performance time
The incidence of adverse effects
Duration of the block
Degree of contralateral motor blockage and lower limb weakness
By using modified bromage scale as following:
Grade I : Free movement of legs and feet Degree of block :Nil (0%)
Grade II :Just able to flex knees with free movement of feet Degree of block :Partial (33%)
Grade III :Unable to flex knees, but with free movement of feet Degree of block: Almost complete (66%)
Grade IV :Unable to move legs or feet Degree of block: Complete (100%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05157516
Brief Title
Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients
Official Title
Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients: A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group ESPB
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block
Arm Title
In group CEA
Arm Type
Active Comparator
Arm Description
Caudal epidural block
Intervention Type
Procedure
Intervention Name(s)
erector spinea block
Intervention Description
the patients will receive a single injection erector spinea block after induction of general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Caudal epidural block
Intervention Description
the patients will receive caudal epidural block after induction of general anesthesia
Primary Outcome Measure Information:
Title
Pain score
Description
By using face, legs, activity, and cry consolability scale [FLACC ]
FLACC scale will be measured as following:
Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10.
Assessment of the final score:
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
2 hours post-operatively
Secondary Outcome Measure Information:
Title
pain scores
Description
By using face, legs, activity, and cry consolability scale [FLACC ]
FLACC scale will be measured as following:
Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10.
Assessment of the final score:
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
at 2 hour intervals during the first 24 hours postoperatively
Title
Block failure rate
Description
The block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively
Time Frame
First hour postoperatively
Title
Block performance time
Time Frame
Preoperative
Title
The incidence of adverse effects
Time Frame
Up to one week after the block
Title
Duration of the block
Time Frame
UP to 48 hours postoperatively
Title
Degree of contralateral motor blockage and lower limb weakness
Description
By using modified bromage scale as following:
Grade I : Free movement of legs and feet Degree of block :Nil (0%)
Grade II :Just able to flex knees with free movement of feet Degree of block :Partial (33%)
Grade III :Unable to flex knees, but with free movement of feet Degree of block: Almost complete (66%)
Grade IV :Unable to move legs or feet Degree of block: Complete (100%)
Time Frame
UP to 48 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II.
Scheduled to undergo hip or proximal femur surgeries.
Exclusion Criteria:
Refusal of participation by parents or caregivers
Known local anesthetic (LA) drug sensitivity
Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3.
Skin lesions or wounds at the site of proposed needle insertion.
Facility Information:
Facility Name
Kasr Alaini hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients
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