- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04539314
Unilateral Transversus Abdominis Plane Block in Pediatrics
Dexmedetomidine as an Adjuvant to Bupivacaine in Unilateral Transversus Abdominis Plane Block in Pediatrics
Study Overview
Status
Intervention / Treatment
Detailed Description
After insertion of venous access, all children received premedication in the form of atropine at a dose of 0.01-0.02 mg/kg. Perioperative monitoring included continuous ECG, pulse oximetry and non-invasive arterial blood pressure. Baseline reading of heart rate, mean arterial blood pressure was recorded after monitor attachment.
General anesthesia will be induced using propofol 1.5-2.5 mg/kg over 20-30 s as tolerated, atracurium 0.5 mg/kg to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium 0.1 mg/kg supplements will be given to maintain muscle relaxation.
TAP block will be performed in All patients immediately after induction patients will be allocated randomly into three equal groups, 30 patients in each as the following.
Group 1 (control group) TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) Group 2 We will carry out TAP block using the same dose of bupivacaine in the control group plus dexmedetomidine 0.5 μg / kg as an adjuvant Group (3) In this participants dexmedetomidine in dose 1 μg / kg will be given as an adjuvant to the control dose of bupivacaine in the TAP block TAP block procedure With the patient in the supine position, the site of the ultrasound and needle entry was sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle located around the midaxillary line with the probe transverse to the abdomen. Anteriorly, the needle passes to come perpendicular to the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line. Then, the local anesthetic will be injected. (Al-Sadek et al.,2014).
The procedure will be performed immediately after induction of anesthesia by candidate anesthesiologist who is not aware of group allocation.
After completion of surgical procedure anesthesia will be discontinued, muscle relaxant reversed using atropine 0.02 mg/kg and 0.05 mg/kg of neostigmine, extubated, and transferred to PACU.
Parameters will be assessed
• Quality of analgesia will be assessed immediately postoperatively and then at 2, 4, 8, 12 and 24 h postoperatively using FLACC scale (face,leg,activity,cry and consolability).
Time to the first analgesic requirement will be recorded from immediately postoperative to the time of FLACC score >6. Acetaminophen (perfalgan) 15 mg/kg IV will be given as rescue analgesia for patients if FLACC score >6 and total dose of acetaminophen will be recorded.
• Hemodynamic data including heart rate (HR) and mean arterial blood pressure (MAP).
Intraoperative any increase in heart rate and or mean arterial blood pressure by more than 20% of baseline values in response to surgical stimulus or thereafter throughout the whole operation warranted administration of intravenous fentanyl (0.5 μg/kg).
- postoperative complication including postoperative hypotension or bradycardia (decrease in MAP or HR by more than 20% of baseline value), postoperative nausea and vomiting (PONV)
- length of hospital stays, and patients or parents' satisfaction assessed on a 5-point scale (Al-Sadek et al.,2014) 1-completely dissatisfied, 2-dissatisfied, 3-not satisfied nor dissatisfied, 4- satisfied 5-completely satisfied
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minia
-
Cairo, Minia, Egypt, 61511
- Amany khairy Abo el-hussein
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA class I or II, aged from 1-7 years old undergoing any lower abdominal surgery that requires skin incision in one side of midline of the anterior abdominal wall
Exclusion Criteria:
- Participants refusing regional block and those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia and hepatic disease or enlargement in addition to those who required emergency procedures or operations that requires exploratory longitudinal midline incision were excluded from the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%)
|
We will carry out the TAP block using 0.5 ml/ kg bupivacaine 0.25%
|
Active Comparator: Dexmedetomidine 0.5 μg group
TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) plus dexmedetomidine 0.5 μg / kg as an adjuvant
|
We will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 0.5 μg / kg
|
Active Comparator: Dexmedetomidine 1 μg group
TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) plus dexmedetomidine 1 μg / kg as an adjuvant
|
We will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 1 μg / kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of analgesia
Time Frame: 24 hours after block
|
Quality of analgesia will be assessed by using FLACC scale (face,leg,activity,cry and consolability)
|
24 hours after block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative complication
Time Frame: For 24 hours after surgery
|
postoperative complication including postoperative hypotension or bradycardia (decrease in MAP or HR by more than 20% of baseline value), postoperative nausea and vomiting (PONV)
|
For 24 hours after surgery
|
parents' satisfaction
Time Frame: 24 hours
|
parents' satisfaction
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Dexmedetomidine
- Bupivacaine
Other Study ID Numbers
- 274:7/2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unilateral TAP Block in Pediatric Patients Undergoing Lower Abdominal Surgery
-
Tanta UniversityCompletedEfficacy of Erector Spinae Plane Block in Lower Limb Surgery in PediatricEgypt
-
Alexandria UniversityCompletedAnalgesic Efficacy of M-TAPA Block Accomplished Prior to Surgery in Patients Undergoing Laparoscopic Gynecological SurgeriesEgypt
Clinical Trials on Bupivacain
-
University Hospital Inselspital, BerneCompletedUrinary Retention | Analgesia, Epidural | UrodynamicsSwitzerland
-
Basaksehir Cam & Sakura Şehir HospitalRecruitingAnesthesia, Local | Post Operative Pain | Fracture of Hip | QoR-15Turkey
-
Assiut UniversityNot yet recruiting
-
Sisli Hamidiye Etfal Training and Research HospitalCompleted
-
Benha UniversityCompletedPostoperative PainEgypt
-
Ankara City Hospital BilkentNot yet recruitingHip Fractures | Spinal Anesthesia
-
University Tunis El ManarRecruitingPostoperative Pain | Analgesia | Anesthesia, Local | Mandible FractureTunisia
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalEnrolling by invitation
-
Istanbul UniversityNot yet recruiting
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalRecruitingPostoperative PainTurkey