AnalgesiaPhase 2/3TABNCT03388671
Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.
A Phase 2/3 study testing TAB Block, Psoas Block and Bupivacaine in people with Analgesia, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Analgesia
- What is being tested?
- TAB Block, Psoas Block and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2017to Dec 2020
- Phase
- Phase 2/3
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last >30minutes (eg. undescended testis and inguinal hernia repair).
- Written consent, free and informed
Who cannot join
- Significant respiratory, cardiac or renal disease
- BMI >95th percentile for age.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Pediatric hospital, faculty of medicine, Assiut university
Asyut, Assiut Governorate, 715715
Hala S Abdelghaffar, MD, +201003812011, hallasaad@yahoo.com
Seham M Moeen, MD, 01006386324, seham.moeen@yahoo.com
About this study
The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.
Read the detailed description
Transversus abdominis plane (TAP) block is a promising effective method for postoperative pain control after major abdominal surgery. TAP block provides analgesia by inhibiting nerve conduction from the anterior abdominal wall arising from the intercostal nerves, subcostal nerves, and first lumbar nerve (T6-L1). Using a landmark technique, it is easily performed, but its popularity has decreased because of reduced efficacy due to inaccurate injection and the potential for intra-peritoneal organ damage. Ultrasound-guided TAP block provides better results and fewer complications, but it requires experienced operators. Surgically administered TAP (sTAP) block guided by the video camera of the laparoscope is a simple technique and may cause no complications. Also, under laparoscopic guidance, block of ilioinguinal, iliohypogastric, and genitofemoral nerves can be possible with anesthetic injection in the plane between psoas major and the fasciae covering its anterior aspects [laparoscopic-assisted psoas (LAP) blockade].
- Conditions
- Analgesia
- Being tested
- TAB Block, Psoas Block, Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAB BlockProcedure or surgery
patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided TAB Block
Psoas BlockProcedure or surgery
patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block
BupivacaineDrug
Also called Bucain
patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block or TAB block
| Study group | Role | What they receive |
|---|---|---|
| TAB Block | Active comparator | Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block. Receives: Procedure: TAB Block; Drug: Bupivacaine |
| Psoas Block | Active comparator | Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block. Receives: Procedure: Psoas Block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC PAIN score
postoperative FLACC pain scores.
Measured: 36hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start25 Dec 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas blocks. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdelghaffar, MD, Principal investigator, Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388671
- Sponsor's protocol ID
- 17300080
- Acronym
- TAB
- Status last verified
- Jul 2020
- First submitted
- 25 Dec 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.
- ClinicalTrials.gov ID
- NCT03388671
- Acronym / sponsor ID
- TAB / 17300080
- Conditions
- Analgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Dec 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Jan 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 aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.
Detailed description
Transversus abdominis plane (TAP) block is a promising effective method for postoperative pain control after major abdominal surgery. TAP block provides analgesia by inhibiting nerve conduction from the anterior abdominal wall arising from the intercostal nerves, subcostal nerves, and first lumbar nerve (T6-L1). Using a landmark technique, it is easily performed, but its popularity has decreased because of reduced efficacy due to inaccurate injection and the potential for intra-peritoneal organ damage. Ultrasound-guided TAP block provides better results and fewer complications, but it requires experienced operators. Surgically administered TAP (sTAP) block guided by the video camera of the laparoscope is a simple technique and may cause no complications. Also, under laparoscopic guidance, block of ilioinguinal, iliohypogastric, and genitofemoral nerves can be possible with anesthetic injection in the plane between psoas major and the fasciae covering its anterior aspects [laparoscopic-assisted psoas (LAP) blockade].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas blocks. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.
| Arm | Type | Receives |
|---|---|---|
| TAB Block | Active comparator | Procedure: TAB Block, Drug: BupivacainePatients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block. |
| Psoas Block | Active comparator | Procedure: Psoas Block, Drug: BupivacainePatients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last >30minutes (eg. undescended testis and inguinal hernia repair).
- Written consent, free and informed
Key exclusion criteria (2 listed)
- Significant respiratory, cardiac or renal disease
- BMI >95th percentile for age.
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 |
|---|---|---|
| TAB Blockpatients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided TAB Block | Procedure or surgery | TAB Block |
| Psoas Blockpatients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block | Procedure or surgery | Psoas Block |
| BupivacaineAlso: Bucainpatients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block or TAB block | Drug | Psoas Block, TAB Block |
Primary outcome
FLACC PAIN score
Time frame: 36hours
postoperative FLACC pain scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Hala S Abdelghaffar, MD principal investigator
Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TAB Block, Psoas Block and Bupivacaine in people with Analgesia, run by Assiut 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 2 inclusion and 2 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 14 Jul 2020. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hala S Abdelghaffar, MD (01003812011 ext. +2088, hallasaad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC PAIN score (time frame: 36hours). 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 14 Jul 2020.