Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery
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|ClinicalTrials.gov Identifier: NCT02723487|
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Bupivacaine 0.125% Drug: Bupivacaine 0.25%||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||October 2017|
No Intervention: Group A
Active Comparator: Group B
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.
Drug: Bupivacaine 0.125%
Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.
Other Name: Plain marcaine
Active Comparator: Group C
patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.
Drug: Bupivacaine 0.25%
Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.
Other Name: Plain marcaine
- pain score [ Time Frame: 12 hours postoperative ]Children's Hospital Eastern Ontario Pain Scale
- Total intraoperative fentanyl consumption [ Time Frame: 12 hours postoperative ]Microgram (ug)
- number of participants with incidence of nausea [ Time Frame: 12 hours postoperative ]number of patients
- number of participants with incidence of hematoma [ Time Frame: 12 hours postoperative ]number of patients
- number of participants with incidence of infection [ Time Frame: 12 hours postoperative ]number of patients
- Total postoperative paracetamol consumption [ Time Frame: 12 hours postoperative ]Milligram (mg)
- Number of participants with incidence of vomiting [ Time Frame: 12 hours postoperative ]number of patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723487
|Assiut university faculty of medicine|
|Principal Investigator:||Abdelrady s Ibrahim, MD||Assistant profossor|