AnesthesiaNCT03701126
Ultrasound Guided TAP Block Versus Caudal Block in Pediatrics
A study testing Transversus Abdominis Plane Block, Caudal Block and Bupivacaine 0.25% Injectable Solution in people with Anesthesia, run by Zagazig University at 1 site in Egypt.
Trial summary
The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound. At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Transversus Abdominis Plane Block, Caudal Block and Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA (American society of anesthiologists) physical status grade I-II.
- Operations not extending more than two hours.
- Unilateral surgeries.
Who cannot join
- Refusal of parents.
- Urgent cases.
- Bilateral or Complicated hernias (i.e., obstructed, strangulated, irreducible …).
- Other contraindication of regional anesthesia e.g. septic focus at site of injection, patients on anticoagulant therapy or suffering from coagulopathy, allergy to local anesthetic drug.
- Prolonged operations more than two hours.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine, Zagazig University.
Zagazig, Alsharkia, 44519
Mohammed AS Mekawy, MSc
About this study
Official title: Ultrasound Guided Transversus Abdominis Plane Block Versus Caudal Block in Inguinal Hernia Repair Surgery in Pediatrics
The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound. At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. In addition to providing postoperative analgesia, caudal block significantly reduces intraoperative analgesic requirements and upper airway complications. Transversus abdominis plane (TAP) block involves infiltration of local anesthetics to the plane between the internal oblique and transversus abdominis muscles. Indeed, TAP block offers a hemodynamic stability, appropriate intra-operative analgesia and post surgical analgesia of the abdominal wall.
Read the detailed description
The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound.
At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. In addition to providing postoperative analgesia, caudal block significantly reduces intraoperative analgesic requirements and upper airway complications.
However, in recent days there is a trend toward the use of peripheral nerve blockade wherever applicable, given the lower incidences of adverse effects when compared with neuron-axial techniques. Furthermore, there may be specific anatomic variations or abnormalities which preclude the use of caudal block.
The abdominal wall consists of three muscular layers, the external oblique abdominis muscle (EOAM), the internal oblique abdominis muscle (IOAM), and the tranversus abdominis muscle (TAM), and their associated fascial sheaths. The central abdominal wall also includes the rectus abdominis muscles and its associated fascial sheath. This muscular wall is innervated by nerve afferents that course through the transversus abdominis neuron-fascial plane.
Transversus abdominis plane (TAP) block involves infiltration of local anesthetics to the plane between the internal oblique and transversus abdominis muscles. Indeed, TAP block offers a hemodynamic stability, appropriate intra-operative analgesia and post surgical analgesia of the abdominal wall.
- Conditions
- Anesthesia
- Being tested
- Transversus Abdominis Plane Block, Caudal Block, Bupivacaine 0.25% Injectable Solution, Ultra-sound guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane BlockProcedure or surgery
ultrasound (US) guided TAP block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).
Caudal BlockProcedure or surgery
ultrasound (US) guided caudal block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).
Bupivacaine 0.25% Injectable SolutionDrug
Dose 1ml /kg of patient body weight
Ultra-sound guidanceDevice
using superficial high frequency probe to guide regional anesthesia
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance Receives: Procedure: Transversus Abdominis Plane Block; Drug: Bupivacaine 0.25% Injectable Solution; Device: Ultra-sound guidance |
| group B | Active comparator | Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance Receives: Procedure: Caudal Block; Drug: Bupivacaine 0.25% Injectable Solution; Device: Ultra-sound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for first analgesic request
by investigator till hospital discharge, then through telephone with parents after discharge
Measured: 24 hours after surgery
Secondary outcomes (4)
Total Opioid consumpsion
Total amount of intra-operative fentanyl consumption.
Measured: During operation
Total Ibuprofen consumption
Total amount of oral ibuprofen consumption postoperative.
Measured: 24 hours after surgery
post operative pain score.
Pain assessment by Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) by investigator till hospital discharge, then through telephone with parents after discharge
Measured: 2 , 4 , 8 , 12 & 24 hours after surgery.
parents satisfaction score.
satisfaction were measured on a 5 point scale of "extremely dissatisfied" to "extremely satisfied" as follows: 1- Completely dissatisfied (worst), 2- Dissatisfied 3- Not satisfied, nor dissatisfied, 4- Satisfied, 5- Completely satisfied (best).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammed Abdullah Seliem Mekawy, Zagazig University
- Investigators
- Mohammed A Refky, MD, Study chair, Faculty of medicine, zagazig university, EgyptDoaa M Farid, MD, Study chair, Faculty of medicine, zagazig university, EgyptAyat A Amer, MD, Study director, Faculty of medicine, zagazig university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701126
- Sponsor's protocol ID
- TAP/caudal block in pediatric
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Transversus Abdominis Plane Block Versus Caudal Block in Inguinal Hernia Repair Surgery in Pediatrics
- ClinicalTrials.gov ID
- NCT03701126
- Acronym / sponsor ID
- TAP/caudal block in pediatric
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound. At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. In addition to providing postoperative analgesia, caudal block significantly reduces intraoperative analgesic requirements and upper airway complications. Transversus abdominis plane (TAP) block involves infiltration of local anesthetics to the plane between the internal oblique and transversus abdominis muscles. Indeed, TAP block offers a hemodynamic stability, appropriate intra-operative analgesia and post surgical analgesia of the abdominal wall.
Detailed description
The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound.
At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. In addition to providing postoperative analgesia, caudal block significantly reduces intraoperative analgesic requirements and upper airway complications.
However, in recent days there is a trend toward the use of peripheral nerve blockade wherever applicable, given the lower incidences of adverse effects when compared with neuron-axial techniques. Furthermore, there may be specific anatomic variations or abnormalities which preclude the use of caudal block.
The abdominal wall consists of three muscular layers, the external oblique abdominis muscle (EOAM), the internal oblique abdominis muscle (IOAM), and the tranversus abdominis muscle (TAM), and their associated fascial sheaths. The central abdominal wall also includes the rectus abdominis muscles and its associated fascial sheath. This muscular wall is innervated by nerve afferents that course through the transversus abdominis neuron-fascial plane.
Transversus abdominis plane (TAP) block involves infiltration of local anesthetics to the plane between the internal oblique and transversus abdominis muscles. Indeed, TAP block offers a hemodynamic stability, appropriate intra-operative analgesia and post surgical analgesia of the abdominal wall.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: Transversus Abdominis Plane Block, Drug: Bupivacaine 0.25% Injectable Solution, Device: Ultra-sound guidanceTransversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance |
| group B | Active comparator | Procedure: Caudal Block, Drug: Bupivacaine 0.25% Injectable Solution, Device: Ultra-sound guidanceCaudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA (American society of anesthiologists) physical status grade I-II.
- Operations not extending more than two hours.
- Unilateral surgeries.
Key exclusion criteria (5 listed)
- Refusal of parents.
- Urgent cases.
- Bilateral or Complicated hernias (i.e., obstructed, strangulated, irreducible …).
- Other contraindication of regional anesthesia e.g. septic focus at site of injection, patients on anticoagulant therapy or suffering from coagulopathy, allergy to local anesthetic drug.
- Prolonged operations more than two hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus Abdominis Plane Blockultrasound (US) guided TAP block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg). | Procedure or surgery | group A |
| Caudal Blockultrasound (US) guided caudal block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg). | Procedure or surgery | group B |
| Bupivacaine 0.25% Injectable SolutionDose 1ml /kg of patient body weight | Drug | group A, group B |
| Ultra-sound guidanceusing superficial high frequency probe to guide regional anesthesia | Device | group A, group B |
Primary outcome
Time for first analgesic request
Time frame: 24 hours after surgery
by investigator till hospital discharge, then through telephone with parents after discharge
4 secondary outcomes
Total Opioid consumpsion
Time frame: During operation
Total Ibuprofen consumption
Time frame: 24 hours after surgery
post operative pain score.
Time frame: 2 , 4 , 8 , 12 & 24 hours after surgery.
parents satisfaction score.
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A Refky, MD study chair
Faculty of medicine, zagazig university, Egypt
Doaa M Farid, MD study chair
Faculty of medicine, zagazig university, Egypt
Ayat A Amer, MD study director
Faculty of medicine, zagazig university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abdominis Plane Block, Caudal Block and Bupivacaine 0.25% Injectable Solution in people with Anesthesia, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed AS Mekawy, MSc (+201154183388, mmekawy40@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for first analgesic request (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.