Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine 0.125%
Bupivacaine 0.25%
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring TAP block, pediatric, Laparoscopic, postoperative pain
Eligibility Criteria
Inclusion Criteria:
- ASA I-II physical status patients.
- Genders Eligible for Study :male.
- All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
- Duration of Laparoscopic procedure not exceeding 90 minutes.
- Written informed consent from parent of guardian .
Exclusion Criteria:
- Sensitivities to local anesthetics.
- Significant renal, liver, or cardiac disease.
- Surgery requiring an open procedure
Sites / Locations
- Assiut university faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Control
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.
Outcomes
Primary Outcome Measures
pain score
Children's Hospital Eastern Ontario Pain Scale
Secondary Outcome Measures
Total intraoperative fentanyl consumption
Microgram (ug)
number of participants with incidence of nausea
number of patients
number of participants with incidence of hematoma
number of patients
number of participants with incidence of infection
number of patients
Total postoperative paracetamol consumption
Milligram (mg)
Number of participants with incidence of vomiting
number of patients
Full Information
NCT ID
NCT02723487
First Posted
March 14, 2016
Last Updated
December 6, 2017
Sponsor
Abdelrady S Ibrahim, MD
1. Study Identification
Unique Protocol Identification Number
NCT02723487
Brief Title
Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery
Official Title
Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abdelrady S Ibrahim, MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.
Detailed Description
A prospective randomized controlled double blind study using a computer generated randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric patients undergoing laparoscopic surgery under general anesthesia.
After induction of general anesthesia and endotracheal intubation, patients in group B and group C will be placed in the supine position and transversus abdominis plane block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe connected to a portable ultrasound unit will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. needle attached to a syringe filled with the Local anesthetic solution will be inserted until it reaches the plane between the internal oblique and transversus abdominis muscles.
After careful aspiration to exclude vascular puncture, injection of bupivacaine will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side .
Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra abdominal pressure will be maintained at 10-12 mmHg.
The use of opioids during the procedure will based on the cardiovascular response to stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient analgesia and will be treated with fentanyl in doses of 1mcg / kg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
TAP block, pediatric, Laparoscopic, postoperative pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
No Intervention
Arm Description
Control
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.125%
Other Intervention Name(s)
Plain marcaine
Intervention Description
Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25%
Other Intervention Name(s)
Plain marcaine
Intervention Description
Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.
Primary Outcome Measure Information:
Title
pain score
Description
Children's Hospital Eastern Ontario Pain Scale
Time Frame
12 hours postoperative
Secondary Outcome Measure Information:
Title
Total intraoperative fentanyl consumption
Description
Microgram (ug)
Time Frame
12 hours postoperative
Title
number of participants with incidence of nausea
Description
number of patients
Time Frame
12 hours postoperative
Title
number of participants with incidence of hematoma
Description
number of patients
Time Frame
12 hours postoperative
Title
number of participants with incidence of infection
Description
number of patients
Time Frame
12 hours postoperative
Title
Total postoperative paracetamol consumption
Description
Milligram (mg)
Time Frame
12 hours postoperative
Title
Number of participants with incidence of vomiting
Description
number of patients
Time Frame
12 hours postoperative
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
According to type of surgery laparoscopic undescended testis
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II physical status patients.
Genders Eligible for Study :male.
All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
Duration of Laparoscopic procedure not exceeding 90 minutes.
Written informed consent from parent of guardian .
Exclusion Criteria:
Sensitivities to local anesthetics.
Significant renal, liver, or cardiac disease.
Surgery requiring an open procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrady s Ibrahim, MD
Organizational Affiliation
Assistant profossor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university faculty of medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24918899
Citation
Long JB, Birmingham PK, De Oliveira GS Jr, Schaldenbrand KM, Suresh S. Transversus abdominis plane block in children: a multicenter safety analysis of 1994 cases from the PRAN (Pediatric Regional Anesthesia Network) database. Anesth Analg. 2014 Aug;119(2):395-399. doi: 10.1213/ANE.0000000000000284.
Results Reference
background
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Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery
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