Anesthesia, LocalNCT04204343
Comparing Analgesic Effects of Caudal and Erector Spinae Plane Blocks in Pediatrics Undergoing Upper Abdominal Surgery
A study testing Bupivacaine 0.7 ml/kg and Bupivacaine 0.5 ml/kg in people with Anesthesia, Local, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Bupivacaine 0.7 ml/kg and Bupivacaine 0.5 ml/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 25 Feb 2022
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- undergoing upper abdominal surgery
- ASA(American Society of Anesthesiology)1-2
Who cannot join
- denial of patient or parents
- infection on the local anesthetic application area
- infection in the central nervous system
- coagulopathy
- brain tumors
- known allergy against local anesthetics
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- anatomical difficulties
- with preexisting cardiac dysfunction
- with history of renal and/or hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Analgesic Effects of Ultrasound-Guided Caudal and Erector Spinae Plane Blocks in Pediatric Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Double-Blinded Study
Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects, time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.
Read the detailed description
Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Blockade of dermatomes between T6 and L1 commonly provides effective postoperative analgesia. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques as they provide both somatic and visceral analgesia. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In the present study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients undergoing upper abdominal surgery. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.
- Conditions
- Anesthesia, Local
- Being tested
- Bupivacaine 0.7 ml/kg, Bupivacaine 0.5 ml/kg
- Keywords
- Erector Spinae Plane Block, Caudal Block, Ultrasound guidance, Postoperative analgesia, Upper abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.7 ml/kgDrug
Also called Marcaine
Bupivacaine 0.25% 0.7 ml/kg
Bupivacaine 0.5 ml/kgDrug
Also called Marcaine
Bupivacaine 0.25% 0.5 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Caudal Block | Active comparator | US-guided caudal block with 0.7 ml/kg 0.25% Bupivacaine Receives: Drug: Bupivacaine 0.7 ml/kg |
| Erector Spinae Plane Block | Active comparator | US-guided erector spinae plane block with 0.5 ml/kg 0.25% Bupivacaine Receives: Drug: Bupivacaine 0.5 ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale
Pain scores between 0-10
Measured: up to 48 hours
Secondary outcomes (6)
length of hospital stay
hospitalisation
Measured: through study completion, an average of 1 week
number patients who require rescue analgesic
number of patients who require IV morphine (0.03 mg/kg) during the first 2 hours and paracetamol in the 48 hours
Measured: up to 48 hours
Time to first analgesic
Duration of postoperative analgesia
Measured: up to 48 hours
Incidence of side effects/complications
hematoma, dural puncture, infections
Measured: up to first week
Time to first mobilization
time to first mobilization
Measured: up to 48 hours
Presence of pain (chronic pain - Visual Analog scale>3)
Chronic pain due to incision after 2-3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Jan 2019
- Primary completion15 Jan 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RANDOMISED DOUBLE BLINDED INTERVENTIONAL
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, Principal investigator, Istanbul University Faculty of Medicine Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204343
- Sponsor's protocol ID
- 2018/1073
- Status last verified
- Mar 2022
- First submitted
- 16 Dec 2019
- Last updated
- 29 Mar 2022
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Analgesic Effects of Ultrasound-Guided Caudal and Erector Spinae Plane Blocks in Pediatric Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Double-Blinded Study
- ClinicalTrials.gov ID
- NCT04204343
- Acronym / sponsor ID
- 2018/1073
- Conditions
- Anesthesia, Local
- Keywords
- Erector Spinae Plane Block, Caudal Block, Ultrasound guidance, Postoperative analgesia, Upper abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 18 Dec 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.
Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects, time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.
Detailed description
Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Blockade of dermatomes between T6 and L1 commonly provides effective postoperative analgesia. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques as they provide both somatic and visceral analgesia. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In the present study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients undergoing upper abdominal surgery. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RANDOMISED DOUBLE BLINDED INTERVENTIONAL
| Arm | Type | Receives |
|---|---|---|
| Caudal Block | Active comparator | Drug: Bupivacaine 0.7 ml/kgUS-guided caudal block with 0.7 ml/kg 0.25% Bupivacaine |
| Erector Spinae Plane Block | Active comparator | Drug: Bupivacaine 0.5 ml/kgUS-guided erector spinae plane block with 0.5 ml/kg 0.25% Bupivacaine |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- undergoing upper abdominal surgery
- ASA(American Society of Anesthesiology)1-2
Key exclusion criteria (9 listed)
- denial of patient or parents
- infection on the local anesthetic application area
- infection in the central nervous system
- coagulopathy
- brain tumors
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 |
|---|---|---|
| Bupivacaine 0.7 ml/kgAlso: MarcaineBupivacaine 0.25% 0.7 ml/kg | Drug | Caudal Block |
| Bupivacaine 0.5 ml/kgAlso: MarcaineBupivacaine 0.25% 0.5 ml/kg | Drug | Erector Spinae Plane Block |
Primary outcome
The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale
Time frame: up to 48 hours
Pain scores between 0-10
6 secondary outcomes
length of hospital stay
Time frame: through study completion, an average of 1 week
number patients who require rescue analgesic
Time frame: up to 48 hours
Time to first analgesic
Time frame: up to 48 hours
Incidence of side effects/complications
Time frame: up to first week
Time to first mobilization
Time frame: up to 48 hours
Presence of pain (chronic pain - Visual Analog scale>3)
Time frame: 3 months
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 29 Mar 2022.
- Ultrasound-Guided Single-Shot Preemptive Erector Spinae Plane Block for Postoperative Pain Management.Link provided by the sponsor.
- Erector Spinae Plane Block in Management of Pain After Kidney Transplantation.Link provided by the sponsor.
- The Erector Spinae Plane Block.Link provided by the sponsor.
- Caudal Epidural Block: An Updated Review of Anatomy and Techniques.Link provided by the sponsor.
- Expert opinion: regional nerve blocks in everyday pediatric urology: 2. Ultrasound-guided regional anesthetic caudal block.Link provided by the sponsor.
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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.
Meltem Savran Karadeniz principal investigator
Istanbul University Faculty of Medicine Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.7 ml/kg and Bupivacaine 0.5 ml/kg in people with Anesthesia, Local, run by Istanbul University at 1 site in Turkey (Türkiye).
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 9 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 29 Mar 2022. 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 Turkey (Türkiye). 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?
The Face, Legs, Activity, Cry, Consolability scale/Visual Analog scale (time frame: up to 48 hours). 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 29 Mar 2022.