Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery. (TAB)
Primary Purpose
Analgesia
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
TAB Block
Psoas Block
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia
Eligibility Criteria
Inclusion Criteria:
- Children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last >30minutes (eg. undescended testis and inguinal hernia repair).
- Written consent, free and informed
Exclusion Criteria:
- Significant respiratory, cardiac or renal disease
- BMI >95th percentile for age.
Sites / Locations
- Pediatric hospital, faculty of medicine, Assiut universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TAB Block
Psoas Block
Arm Description
Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block.
Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block.
Outcomes
Primary Outcome Measures
FLACC PAIN score
postoperative FLACC pain scores.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03388671
Brief Title
Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.
Acronym
TAB
Official Title
Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 25, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.
Detailed Description
Transversus abdominis plane (TAP) block is a promising effective method for postoperative pain control after major abdominal surgery. TAP block provides analgesia by inhibiting nerve conduction from the anterior abdominal wall arising from the intercostal nerves, subcostal nerves, and first lumbar nerve (T6-L1). Using a landmark technique, it is easily performed, but its popularity has decreased because of reduced efficacy due to inaccurate injection and the potential for intra-peritoneal organ damage. Ultrasound-guided TAP block provides better results and fewer complications, but it requires experienced operators. Surgically administered TAP (sTAP) block guided by the video camera of the laparoscope is a simple technique and may cause no complications. Also, under laparoscopic guidance, block of ilioinguinal, iliohypogastric, and genitofemoral nerves can be possible with anesthetic injection in the plane between psoas major and the fasciae covering its anterior aspects [laparoscopic-assisted psoas (LAP) blockade].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas blocks. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.
Masking
ParticipantOutcomes Assessor
Masking Description
The data collection personnel and the patients' guardians will be blinded to the group assignment.
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAB Block
Arm Type
Active Comparator
Arm Description
Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block.
Arm Title
Psoas Block
Arm Type
Active Comparator
Arm Description
Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block.
Intervention Type
Procedure
Intervention Name(s)
TAB Block
Intervention Description
patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided TAB Block
Intervention Type
Procedure
Intervention Name(s)
Psoas Block
Intervention Description
patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Bucain
Intervention Description
patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block or TAB block
Primary Outcome Measure Information:
Title
FLACC PAIN score
Description
postoperative FLACC pain scores.
Time Frame
36hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last >30minutes (eg. undescended testis and inguinal hernia repair).
Written consent, free and informed
Exclusion Criteria:
Significant respiratory, cardiac or renal disease
BMI >95th percentile for age.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hala S Abdelghaffar, MD
Phone
01003812011
Ext
+2088
Email
hallasaad@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Seham M Moeen, MD
Phone
01006386324
Ext
+2088
Email
seham.moeen@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala S Abdelghaffar, MD
Organizational Affiliation
Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric hospital, faculty of medicine, Assiut university
City
Assiut
State/Province
Assiut Governorate
ZIP/Postal Code
715715
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala S Abdelghaffar, MD
Phone
+201003812011
Email
hallasaad@yahoo.com
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, MD
Phone
01006386324
Email
seham.moeen@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.
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