Regional AnesthesiaNCT05286190
Caudal Block and Transversus Abdominis Plane Block in Pediatric Inguinal Hernia Repair
A study testing Bupivacaine 0.25% Injectable Solution in people with Regional Anesthesia and Postoperative Pain, Acute, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Pediatric inguinal hernia repair (IHR) candidates experiences ordinarily mild to moderate pain, rarely severe pain in the postoperative period. Caudal epidural block (CEB) and transversus abdominis plane block (TAPB) are two effective postoperative analgesia options. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia, Postoperative Pain, Acute
- What is being tested?
- Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2017to 31 Oct 2018
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- patients aged 1-7 years who were scheduled for elective bilateral open IHR included in the study
Who cannot join
- Patients with relative or absolute contraindications to TAPB or CEB, patients with chronic constipation or chronic pain disorders that may affect the evaluation of postoperative pain scores, patients who underwent emergency surgery, and patients with a history of allergic reaction to local anesthetics were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Meltem Savran Karadeniz
Istanbul, Fatih, 34000
About this study
Official title: Effects Of Ultrasound Guided Caudal Epidural And Transversus Abdominis Plane Block On Postoperative Analgesia In Pediatric Inguinal Hernia Repair Surgeries
Pediatric inguinal hernia repair (IHR) candidates experiences ordinarily mild to moderate pain, rarely severe pain in the postoperative period. Caudal epidural block (CEB) and transversus abdominis plane block (TAPB) are two effective postoperative analgesia options. In this randomized study, it is aimed to compare the effects of CEB and TAPB on postoperative pain scores, additional analgesic requirement, postoperative nausea and vomiting incidence, procedural complications, family and surgeon satisfaction, length of hospital stay, chronic pain development in pediatric bilateral open IHR.
Read the detailed description
Inguinal hernia repair (IHR) is the second common operation in pediatric surgery practice following appendectomy and bilateral repair is needed in 10.9% of the cases due to presence of contralateral inguinal hernia. After IHR, the children generally experiences mild to moderate pain, and occasional severe pain. For pediatric population the prevalence of chronic pain after IHR is 5% which is a solid cause for severe pain.
Adequate pain control is a crucial part of perioperative management to reduce morbidity and ensure family and patient satisfaction especially after pediatric surgeries. Although there are substantial studies to show how to assess and manage the postoperative pain in children, the pain control is often not achieved. Several analgesic regimens including systemic medications and/or regional analgesia methods may be preferred by clinicians. As previous studies revealed; best combination for pain management after pediatric IHR is still obscure.
Caudal epidural block (CEB) and transversus abdominis plane block (TAPB) are the two regional analgesia methods which may be chosen for multimodal analgesia. CEB is accepted as gold standard for lower abdominal surgeries in children which diminishes somatic and visceral pain with a duration of 6 hours. TAPB is another regional analgesia method which covers only somatic pain up to 24 hours postoperatively with lower complication rates compared to CEB. The results of clinical studies examining the effects of CEB and TAPB on early postoperative pain after pediatric IHR are conflicting. Currently, the effects of these blocks on the incidence of chronic pain after pediatric IHR is not well-investigated in the literature. As a matter of fact, there are no recommendations for bilateral IHR in pediatric postoperative pain guidelines, despite these surgical procedures being an independent risk factor for severe pain.
In this randomized study, it is aimed to compare the effects of ultrasound (US) guided CEB and TAPB on postoperative analgesia. Our hypothesis was that bilateral TAPB block will be equally effective as CEB in the early postoperative period and the analgesic duration will be longer than CEB. Our primary outcome was FLACC (face, legs, activity, cry, consolability) scores in postoperative 24 hours. The secondary outcomes included additional analgesic requirements, postoperative nausea vomiting incidence, procedural complications, length of hospital stay, family and surgeon satisfaction and chronic pain development at the postoperative 2nd month.
- Conditions
- Regional Anesthesia, Postoperative Pain, Acute
- Being tested
- Bupivacaine 0.25% Injectable Solution
- Keywords
- US guided Caudal Epidural Block, US guided Transversus Abdominis Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% Injectable SolutionDrug
Also called Marcaine
Bupivacaine 0.25% Injectable Solution
| Study group | Role | What they receive |
|---|---|---|
| Transversus Abdominis Plane Block | Active comparator | US-guided Transversus Abdominis Plane Block was applied with 0.5 ml/kg of %25 Bupivacaine at each side before the surgical incision Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| Caudal Epidural Block | Active comparator | US-guided Caudal Block was applied with 0.7ml/kg of %25 Bupivacaine before the surgical incision Receives: Drug: Bupivacaine 0.25% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC SCORES (FACE, LEG, ACTIVITY, CONSOLABILITY, CRY)
It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild, 4-7 as moderate, and 8-10 as severe pain.
Measured: Up to 24 hours
Secondary outcomes (7)
PONV (Postoperative nausea and vomiting)
Number of patients with nausea vomiting
Measured: Up to 24 hours
Additional analgesic requirement
Number of patients who require paracetamol (15 mg/kg) and tramadol (1 mg/kg)
Measured: Up to 24 hours
Family satisfaction
A 3-point scale (satisfied:3; neutral:2, dissatisfied:1)
Measured: Up to 24 hours
Surgeon satisfaction
A 3-point scale (satisfied:3; neutral:2, dissatisfied:1)
Measured: Up to 24 hours
Complications
Possible complications related to caudal and transversus abdominis plane block (hematoma, infection and perforation)
Measured: Up to 24 hours
Revised Bieri faces pain scale
Revised Bieri faces pain scale used for assessment of chronic pain. Score the chosen face 0,2,4,6,8,10 counting left to right so '0'=no pain and '10'=very much pain
Measured: At postoperative 2nd month
Length of hospital stay
Hospitalisation
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Oct 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286190
- Sponsor's protocol ID
- 2017/1123
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Polat H, Senturk E, Savran Karadeniz M, Bingul ES, Emre Demirel E, Erginel B, Tugrul KM. Effects of ultrasound guided caudal epidural and transversus abdominis plane block on postoperative analgesia in pediatric inguinal hernia repair surgeries. J Pediatr Urol. 2023 Apr;19(2):213.e1-213.e7. doi: 10.1016/j.jpurol.2022.11.005. Epub 2022 Nov 15.
PubMed 36446689
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Ultrasound Guided Caudal Epidural And Transversus Abdominis Plane Block On Postoperative Analgesia In Pediatric Inguinal Hernia Repair Surgeries
- ClinicalTrials.gov ID
- NCT05286190
- Acronym / sponsor ID
- 2017/1123
- Conditions
- Regional Anesthesia, Postoperative Pain, Acute
- Keywords
- US guided Caudal Epidural Block, US guided Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 18 Mar 2022 (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.
Pediatric inguinal hernia repair (IHR) candidates experiences ordinarily mild to moderate pain, rarely severe pain in the postoperative period. Caudal epidural block (CEB) and transversus abdominis plane block (TAPB) are two effective postoperative analgesia options. In this randomized study, it is aimed to compare the effects of CEB and TAPB on postoperative pain scores, additional analgesic requirement, postoperative nausea and vomiting incidence, procedural complications, family and surgeon satisfaction, length of hospital stay, chronic pain development in pediatric bilateral open IHR.
Detailed description
Inguinal hernia repair (IHR) is the second common operation in pediatric surgery practice following appendectomy and bilateral repair is needed in 10.9% of the cases due to presence of contralateral inguinal hernia. After IHR, the children generally experiences mild to moderate pain, and occasional severe pain. For pediatric population the prevalence of chronic pain after IHR is 5% which is a solid cause for severe pain.
Adequate pain control is a crucial part of perioperative management to reduce morbidity and ensure family and patient satisfaction especially after pediatric surgeries. Although there are substantial studies to show how to assess and manage the postoperative pain in children, the pain control is often not achieved. Several analgesic regimens including systemic medications and/or regional analgesia methods may be preferred by clinicians. As previous studies revealed; best combination for pain management after pediatric IHR is still obscure.
Caudal epidural block (CEB) and transversus abdominis plane block (TAPB) are the two regional analgesia methods which may be chosen for multimodal analgesia. CEB is accepted as gold standard for lower abdominal surgeries in children which diminishes somatic and visceral pain with a duration of 6 hours. TAPB is another regional analgesia method which covers only somatic pain up to 24 hours postoperatively with lower complication rates compared to CEB. The results of clinical studies examining the effects of CEB and TAPB on early postoperative pain after pediatric IHR are conflicting. Currently, the effects of these blocks on the incidence of chronic pain after pediatric IHR is not well-investigated in the literature. As a matter of fact, there are no recommendations for bilateral IHR in pediatric postoperative pain guidelines, despite these surgical procedures being an independent risk factor for severe pain.
In this randomized study, it is aimed to compare the effects of ultrasound (US) guided CEB and TAPB on postoperative analgesia. Our hypothesis was that bilateral TAPB block will be equally effective as CEB in the early postoperative period and the analgesic duration will be longer than CEB. Our primary outcome was FLACC (face, legs, activity, cry, consolability) scores in postoperative 24 hours. The secondary outcomes included additional analgesic requirements, postoperative nausea vomiting incidence, procedural complications, length of hospital stay, family and surgeon satisfaction and chronic pain development at the postoperative 2nd month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus Abdominis Plane Block | Active comparator | Drug: Bupivacaine 0.25% Injectable SolutionUS-guided Transversus Abdominis Plane Block was applied with 0.5 ml/kg of %25 Bupivacaine at each side before the surgical incision |
| Caudal Epidural Block | Active comparator | Drug: Bupivacaine 0.25% Injectable SolutionUS-guided Caudal Block was applied with 0.7ml/kg of %25 Bupivacaine before the surgical incision |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients aged 1-7 years who were scheduled for elective bilateral open IHR included in the study
Key exclusion criteria (1 listed)
- Patients with relative or absolute contraindications to TAPB or CEB, patients with chronic constipation or chronic pain disorders that may affect the evaluation of postoperative pain scores, patients who underwent emergency surgery, and patients with a history of allergic reaction to local anesthetics were excluded from the study.
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 0.25% Injectable SolutionAlso: MarcaineBupivacaine 0.25% Injectable Solution | Drug | Caudal Epidural Block, Transversus Abdominis Plane Block |
Primary outcome
FLACC SCORES (FACE, LEG, ACTIVITY, CONSOLABILITY, CRY)
Time frame: Up to 24 hours
It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild, 4-7 as moderate, and 8-10 as severe pain.
7 secondary outcomes
PONV (Postoperative nausea and vomiting)
Time frame: Up to 24 hours
Additional analgesic requirement
Time frame: Up to 24 hours
Family satisfaction
Time frame: Up to 24 hours
Surgeon satisfaction
Time frame: Up to 24 hours
Complications
Time frame: Up to 24 hours
Revised Bieri faces pain scale
Time frame: At postoperative 2nd month
Length of hospital stay
Time frame: Through study completion, an average of 1 week
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 6 Apr 2022.
- Derived from this study: PubMed 36446689Polat H, Senturk E, Savran Karadeniz M, Bingul ES, Emre Demirel E, Erginel B, Tugrul KM. Effects of ultrasound guided caudal epidural and transversus abdominis plane block on postoperative analgesia in pediatric inguinal hernia repair surgeries. J Pediatr Urol. 2023 Apr;19(2):213.e1-213.e7. doi: 10.1016/j.jpurol.2022.11.005. Epub 2022 Nov 15.
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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 Bupivacaine 0.25% Injectable Solution in people with Regional Anesthesia and Postoperative Pain, Acute, 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 1 inclusion and 1 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 6 Apr 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?
FLACC SCORES (FACE, LEG, ACTIVITY, CONSOLABILITY, CRY) (time frame: Up to 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 NCT05286190, which also lists 1 linked publication.
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 6 Apr 2022.