Analgesia, EpiduralNCT03482947
TAP vs Caudal Block Using Dexmedetomidine/ Bupivacaine for Post Operative Analgesia
A study testing ultrasonography-guided TAP block and Caudal epidural block in people with Analgesia, Epidural, run by Assiut University at 1 site in Egypt.
Trial summary
Caudal epidural block is a well-established and commonly performed regional neuraxial technique for providing intraoperative and postoperative analgesia in children scheduled for lower abdomen/perineal surgical interventions. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Analgesia, Epidural
- What is being tested?
- ultrasonography-guided TAP block and Caudal epidural block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Oct 2020
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients 2-8 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TAP vs Caudal Block Using Dexmedetomidine/Bupivacaine Combination for Postoperative Analgesia in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair
Caudal epidural block is a well-established and commonly performed regional neuraxial technique for providing intraoperative and postoperative analgesia in children scheduled for lower abdomen/perineal surgical interventions. Although the efficacy and safety of Caudal epidural block are fairly high, the associated complications, such as inadvertent dural puncture, unwarranted motor blockade of the lower limbs, and disturbance of bladder function, limit its use. Furthermore, a major limitation of an uncomplicated Caudal epidural block when administered as a "single-shot" technique is its brief duration of action (up to 6 hours), which makes administration of additional analgesics necessary .
Read the detailed description
Ultrasonography guidance, by virtue of real-time visualization of the muscle layers and fascial planes, has significantly facilitated practice of regional nerve blockade for it offers confirmation of the spread of the local anesthetic drug in the correct space. Interestingly, there has been a reinvigoration of interest in ultrasonography-guided transversus abdominis plane block in children since its emergence as a valid postoperative analgesia alternative in adults undergoing abdominal surgery. transversus abdominis plane block involves blockade of spinal afferent nerves in the neurofascial plane between the internal oblique and transversus abdominis muscle. Whereas the advantages (reduction in pain intensity/analgesic requirements) of ultrasonography-guided transversus abdominis plane block have been well documented in adults in the first 48 hours post surgery, in children, its use as a primary postoperative analgesia technique remains limited. Caudal anesthesia is easy to perform in younger children; however, its main disadvantage is the short duration of action. Even bupivacaine, along-acting local anesthetic drug, can provide only4-8 h of analgesia. Dexmedetomidine is a highly selective alfa2 agonist with sedative and analgesic properties. It has an alfa1/2 selectivity ratio of 1600 : 1, which is eight times more potent than clonidine (200 : 1)[16]. DEX has been used effectively in intensive care to aid weaning from mechanical ventilation and is being used increasingly in children
- Conditions
- Analgesia, Epidural
- Being tested
- ultrasonography-guided TAP block, Caudal epidural block
- Keywords
- Dexmedetomidine, pediatrics; postoperative;, Analgesia; caudal
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonography-guided TAP blockDrug
(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).
Caudal epidural blockDrug
(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine)
| Study group | Role | What they receive |
|---|---|---|
| TAP | Experimental | ultrasonography-guided transversus abdominis plane block administration of (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine). Receives: Drug: ultrasonography-guided TAP block |
| Caudal | Experimental | Caudal epidural block administration of (1 mL/kg of bupivacaine 0.25% \&1 μ/kg dexmedetomidine Receives: Drug: Caudal epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia.
time for first analgesic request
Measured: 24 hours
Secondary outcomes (2)
Postoperative analgesia
total amount analgesic administered
Measured: 24 hours
Postoperative pain
using the FLACC scale.Rate child on each of the five categories (face, legs, arms, crying, consolability). Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Dec 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Analgesia, EpiduralStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482947
- Sponsor's protocol ID
- TAP/ECB
- Status last verified
- Sep 2021
- First submitted
- 18 Mar 2018
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsui BC, Berde CB. Caudal analgesia and anesthesia techniques in children. Curr Opin Anaesthesiol. 2005 Jun;18(3):283-8. doi: 10.1097/01.aco.0000169236.91185.5b.
PubMed 16534352Koul A, Pant D, Sood J. Caudal clonidine in day-care paediatric surgery. Indian J Anaesth. 2009 Aug;53(4):450-4.
PubMed 20640207Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.
PubMed 25393589Menzies R, Congreve K, Herodes V, Berg S, Mason DG. A survey of pediatric caudal extradural anesthesia practice. Paediatr Anaesth. 2009 Sep;19(9):829-36. doi: 10.1111/j.1460-9592.2009.03116.x.
PubMed 19691690
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAP vs Caudal Block Using Dexmedetomidine/Bupivacaine Combination for Postoperative Analgesia in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03482947
- Acronym / sponsor ID
- TAP/ECB
- Conditions
- Analgesia, Epidural
- Keywords
- Dexmedetomidine, pediatrics; postoperative;, Analgesia; caudal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 29 Mar 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.
Caudal epidural block is a well-established and commonly performed regional neuraxial technique for providing intraoperative and postoperative analgesia in children scheduled for lower abdomen/perineal surgical interventions. Although the efficacy and safety of Caudal epidural block are fairly high, the associated complications, such as inadvertent dural puncture, unwarranted motor blockade of the lower limbs, and disturbance of bladder function, limit its use. Furthermore, a major limitation of an uncomplicated Caudal epidural block when administered as a "single-shot" technique is its brief duration of action (up to 6 hours), which makes administration of additional analgesics necessary .
Detailed description
Ultrasonography guidance, by virtue of real-time visualization of the muscle layers and fascial planes, has significantly facilitated practice of regional nerve blockade for it offers confirmation of the spread of the local anesthetic drug in the correct space. Interestingly, there has been a reinvigoration of interest in ultrasonography-guided transversus abdominis plane block in children since its emergence as a valid postoperative analgesia alternative in adults undergoing abdominal surgery. transversus abdominis plane block involves blockade of spinal afferent nerves in the neurofascial plane between the internal oblique and transversus abdominis muscle. Whereas the advantages (reduction in pain intensity/analgesic requirements) of ultrasonography-guided transversus abdominis plane block have been well documented in adults in the first 48 hours post surgery, in children, its use as a primary postoperative analgesia technique remains limited. Caudal anesthesia is easy to perform in younger children; however, its main disadvantage is the short duration of action. Even bupivacaine, along-acting local anesthetic drug, can provide only4-8 h of analgesia. Dexmedetomidine is a highly selective alfa2 agonist with sedative and analgesic properties. It has an alfa1/2 selectivity ratio of 1600 : 1, which is eight times more potent than clonidine (200 : 1)[16]. DEX has been used effectively in intensive care to aid weaning from mechanical ventilation and is being used increasingly in children
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP | Experimental | Drug: ultrasonography-guided TAP blockultrasonography-guided transversus abdominis plane block administration of (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine). |
| Caudal | Experimental | Drug: Caudal epidural blockCaudal epidural block administration of (1 mL/kg of bupivacaine 0.25% \&1 μ/kg dexmedetomidine |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients 2-8 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ultrasonography-guided TAP block(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine). | Drug | TAP |
| Caudal epidural block(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine) | Drug | Caudal |
Primary outcome
Postoperative analgesia.
Time frame: 24 hours
time for first analgesic request
2 secondary outcomes
Postoperative analgesia
Time frame: 24 hours
Postoperative pain
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Results publication: PubMed 16534352Tsui BC, Berde CB. Caudal analgesia and anesthesia techniques in children. Curr Opin Anaesthesiol. 2005 Jun;18(3):283-8. doi: 10.1097/01.aco.0000169236.91185.5b.
- Results publication: PubMed 20640207Koul A, Pant D, Sood J. Caudal clonidine in day-care paediatric surgery. Indian J Anaesth. 2009 Aug;53(4):450-4.
- Results publication: PubMed 25393589Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.
- Results publication: PubMed 19691690Menzies R, Congreve K, Herodes V, Berg S, Mason DG. A survey of pediatric caudal extradural anesthesia practice. Paediatr Anaesth. 2009 Sep;19(9):829-36. doi: 10.1111/j.1460-9592.2009.03116.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonography-guided TAP block and Caudal epidural block in people with Analgesia, Epidural, 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 17 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03482947, which also lists 4 linked publications.
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 17 Sep 2021.