Pain, PostoperativeNCT04049838
Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children
A study testing postoperative analgesia for lower abdominal surgery in children in people with Pain, Postoperative, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- postoperative analgesia for lower abdominal surgery in children
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Feb 2019to 5 Dec 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children from 1- 7 years
- scheduled to undergo lower abdominal surgery
Who cannot join
- bleeding disorders
- emergency surgery
- skin lesion at site of needle insertion
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Aini
Cairo, 56545
Mohsen M Ibrahim, MD
Noha Asem, MD, 01003657120, kasralainirec@gmail.com
About this study
Official title: Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children . Randomized Controlled Trial
Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children
Read the detailed description
the investigators will compare the effect of posterior Transversus abdominis plan block versus the effect of lateral transversus abdominis plan bock regarding the duration of analgesia and patients satisfaction the study will be conducted on 69 children aged from 1 to 7 years presented for lower abdominal surgery.
- Conditions
- Pain, Postoperative
- Being tested
- postoperative analgesia for lower abdominal surgery in children
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative analgesia for lower abdominal surgery in childrenProcedure or surgery
compare lateral and posterior approaches of trannsversus abdominis plane block for analgesia after lower abdominal surgery in children
| Study group | Role | What they receive |
|---|---|---|
| lateral transversus abdominis block | Active comparator | patients will take lateral transversus abdominis plan block. The block will be done unilaterally on the same side of proposed surery with 0.25% bupivacaine at a volume of 1 ml·kg-1 Receives: Procedure: postoperative analgesia for lower abdominal surgery in children |
| posterior tansversus abodominis plane block | Active comparator | patients will take posterior transversus abdominis plane block. The block will be done unilaterally on the same side of proposed surery with 0.25% bupivacaine at a volume of 1 ml·kg-1 Receives: Procedure: postoperative analgesia for lower abdominal surgery in children |
| convential analgesia | Active comparator | conventional analgesia in form of 1 micrograms. Kg-1 fentanyl and paracetamol 15 mg. Kg-1 suppositories Receives: Procedure: postoperative analgesia for lower abdominal surgery in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain assessment by the CHEOPS score
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) for Post-Op Pediatric Pain the score is based on 6 crtiteria:
- crying
- facial expression
- child verbal expression
- body positiion
- touching or grabbing at wound
- legs position criterion 1 is given a score of 1-3, criterion 2 and 3 are given score 0-2, criterion 4,5 and 6 are given a score 1-2 making the worst possible score 13 while the least possible score is 4. a total score of 6 or less indicates adequate analgesia
Measured: the first 24 hours postoperative
Secondary outcomes (2)
heart rate
Measurement of heart rate (beats per minute)
Measured: at 2,4,8,12 and 24 hours postoperative
Mean arterial blood pressure
Measurement of Mean arterial blood pressure ( mm Hg)
Measured: at 2,4,8,12 and 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start16 Feb 2019
- Primary completion5 Nov 2019 (estimated)
- Study completion5 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control study
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Maher Kamel, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049838
- Sponsor's protocol ID
- 011223456
- Status last verified
- Oct 2019
- First submitted
- 21 Jul 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children . Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04049838
- Acronym / sponsor ID
- 011223456
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 16 Feb 2019 (actual)
- Primary completion
- 5 Nov 2019 (estimated)
- Study completion
- 5 Dec 2019 (estimated)
- First posted
- 8 Aug 2019 (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.
Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children
Detailed description
the investigators will compare the effect of posterior Transversus abdominis plan block versus the effect of lateral transversus abdominis plan bock regarding the duration of analgesia and patients satisfaction the study will be conducted on 69 children aged from 1 to 7 years presented for lower abdominal surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized control study
| Arm | Type | Receives |
|---|---|---|
| lateral transversus abdominis block | Active comparator | Procedure: postoperative analgesia for lower abdominal surgery in childrenpatients will take lateral transversus abdominis plan block. The block will be done unilaterally on the same side of proposed surery with 0.25% bupivacaine at a volume of 1 ml·kg-1 |
| posterior tansversus abodominis plane block | Active comparator | Procedure: postoperative analgesia for lower abdominal surgery in childrenpatients will take posterior transversus abdominis plane block. The block will be done unilaterally on the same side of proposed surery with 0.25% bupivacaine at a volume of 1 ml·kg-1 |
| convential analgesia | Active comparator | Procedure: postoperative analgesia for lower abdominal surgery in childrenconventional analgesia in form of 1 micrograms. Kg-1 fentanyl and paracetamol 15 mg. Kg-1 suppositories |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children from 1- 7 years
- scheduled to undergo lower abdominal surgery
Key exclusion criteria (3 listed)
- bleeding disorders
- emergency surgery
- skin lesion at site of needle insertion
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 |
|---|---|---|
| postoperative analgesia for lower abdominal surgery in childrencompare lateral and posterior approaches of trannsversus abdominis plane block for analgesia after lower abdominal surgery in children | Procedure or surgery | convential analgesia, lateral transversus abdominis block, posterior tansversus abodominis plane block |
Primary outcome
postoperative pain assessment by the CHEOPS score
Time frame: the first 24 hours postoperative
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) for Post-Op Pediatric Pain the score is based on 6 crtiteria: 1. crying 2. facial expression 3. child verbal expression 4. body positiion 5. touching or grabbing at wound 6. legs position criterion 1 is given a score of 1-3, criterion 2 and 3 are given score 0-2, criterion 4,5 and 6 are given a score 1-2 making the worst possible score 13 while the least possible score is 4. a total score of 6 or less indicates adequate analgesia
2 secondary outcomes
heart rate
Time frame: at 2,4,8,12 and 24 hours postoperative
Mean arterial blood pressure
Time frame: at 2,4,8,12 and 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative analgesia for lower abdominal surgery in children in people with Pain, Postoperative, run by Kasr El Aini Hospital 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 2 inclusion and 3 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 21 Oct 2019. 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 Mohamed M Kamel, MD (01005238534, mohamedmaher959@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain assessment by the CHEOPS score (time frame: the first 24 hours postoperative). 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 21 Oct 2019.