Postoperative PainNCT06895382
Caudal Epidural Vs. TAP Block for Postoperative Analgesia in Pediatric Infraumbilical Surgery: a RCT
A study testing Caudal Epidural Block, Transversus Abdominis Plane (TAP) Block and Bupivacaine 0.25% in people with Postoperative Pain and Pediatric Surgery, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigates the postoperative analgesic efficacy of caudal epidural block versus ultrasound-guided transversus abdominis plane (TAP) block in pediatric patients undergoing infraumbilical surgery. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Postoperative Pain, Pediatric Surgery, Anesthesia, Local
- What is being tested?
- Caudal Epidural Block, Transversus Abdominis Plane (TAP) Block and Bupivacaine 0.25%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 15 Dec 2023
- 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
- Pediatric patients aged 1 to 7 years.
- ASA Physical Status I-II.
- Undergoing infraumbilical abdominal surgery (e.g., hernia repair, orchiopexy, circumcision).
- Parental written informed consent obtained.
Who cannot join
- Contraindications to regional anesthesia, such as:
- Coagulopathy or bleeding disorders.
- Local infection at the injection site.
- Known allergy to local anesthetics.
- Neurological conditions (e.g., degenerative neuropathy, brain tumors, increased intracranial pressure).
- Intellectual disabilities affecting pain assessment.
- Chronic pain conditions or opioid use before surgery.
- Parental refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Caudal Epidural Block and Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Pediatric Infraumbilical Surgery: a Randomized Controlled Trial
This randomized controlled trial investigates the postoperative analgesic efficacy of caudal epidural block versus ultrasound-guided transversus abdominis plane (TAP) block in pediatric patients undergoing infraumbilical surgery.
A total of 60 pediatric patients (aged 1 to 7 years, ASA I-II) were randomly assigned to one of two groups:
Read more
- Group C (Caudal Block): Received 1 mL/kg of 0.25% bupivacaine in the caudal epidural space.
- Group T (TAP Block): Received 0.3 mL/kg of 0.25% bupivacaine injected into the transversus abdominis plane under ultrasound guidance.
Primary Outcome:
- Postoperative FLACC pain scores at 2, 6, 12, and 24 hours.
Secondary Outcomes:
- Total analgesic consumption (including rescue analgesia).
- Intraoperative hemodynamic parameters (heart rate, blood pressure, SpO₂).
- Incidence of nausea and vomiting (PONV).
- Parental satisfaction scores.
The study aims to determine which regional anesthesia technique provides superior pain relief and reduces systemic analgesic requirements in pediatric patients.
Read the detailed description
Postoperative pain management in pediatric patients is a challenge due to difficulties in pain assessment and concerns about opioid-related adverse effects. While caudal epidural block has traditionally been the standard of care for infraumbilical pediatric surgeries, ultrasound-guided transversus abdominis plane (TAP) block has emerged as a promising alternative with the potential for longer-lasting analgesia and fewer motor block complications.
This randomized controlled trial was conducted at Tekirdağ Namık Kemal University Hospital between December 2022 and December 2023. A total of 60 pediatric patients (aged 1-7 years, ASA I-II) undergoing infraumbilical surgery were enrolled and randomly assigned to receive either:
- Caudal epidural block (1 mL/kg of 0.25% bupivacaine via the sacral hiatus).
- TAP block (0.3 mL/kg of 0.25% bupivacaine in the fascial plane between the internal oblique and transversus abdominis muscles under ultrasound guidance).
General anesthesia was induced using sevoflurane inhalation, followed by propofol (2-3 mg/kg) and fentanyl (1 µg/kg) for IV induction. A laryngeal mask airway (LMA) was used, and anesthesia was maintained with sevoflurane at a MAC of 1.0%.
Outcome Measures:
- Primary Outcome:
- FLACC pain scores at 2, 6, 12, and 24 hours postoperatively.
- Secondary Outcomes:
- Total postoperative analgesic consumption (including rescue analgesia).
- Hemodynamic parameters (HR, SBP, DBP, SpO₂) recorded at predefined intraoperative time points.
- Incidence of postoperative nausea and vomiting (PONV).
- Parental satisfaction scores collected post-discharge.
Statistical Analysis:
Data were analyzed using SPSS 25.0. Sample size was determined using G*Power 3.1.9.2, with an effect size (d) of 0.75, power of 0.80, and Type I error of 0.05. The study followed randomized allocation with blinding of pain assessors.
This study aims to determine whether TAP block provides equivalent or superior analgesia compared to caudal epidural block in pediatric patients undergoing infraumbilical surgeries. Findings will help guide future pediatric regional anesthesia protocols.
- Conditions
- Postoperative Pain, Pediatric Surgery, Anesthesia, Local, Regional Anesthesia, Abdominal Surgery
- Being tested
- Caudal Epidural Block, Transversus Abdominis Plane (TAP) Block, Bupivacaine 0.25%
- Keywords
- Caudal Epidural Block, Transversus Abdominis Plane Block, Pediatric Pain Management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Epidural BlockProcedure or surgery
Also called Caudal Block, Caudal Anesthesia
A caudal epidural block was performed after the induction of general anesthesia. Using a 35-mm 22G or 30-mm 25G block needle, the sacral hiatus was identified, and the needle was inserted through the sacrococcygeal ligament into the epidural space under aseptic conditions. After confirming negative aspiration for cerebrospinal fluid or blood, 1 mL/kg of 0.25% bupivacaine was administered.
Transversus Abdominis Plane (TAP) BlockProcedure or surgery
Also called TAP Block, Ultrasound-Guided TAP Block
A transversus abdominis plane (TAP) block was performed after the induction of general anesthesia. Using a 22G, 50-mm insulated block needle, the injection was administered under ultrasound guidance using a linear probe and in-plane technique. The needle was advanced into the fascial plane between the internal oblique and transversus abdominis muscles. After confirming placement with a 0.5-1 mL test dose of 0.9% NaCl and negative aspiration for blood, 0.3 mL/kg of 0.25% bupivacaine was administered.
Bupivacaine 0.25%Drug
0.25% bupivacaine was administered in both intervention arms as part of the regional anesthesia procedure In the Caudal Block group, 1 mL/kg of 0.25% bupivacaine was administered into the caudal epidural space.
In the TAP Block group, 0.3 mL/kg of 0.25% bupivacaine was administered into the transversus abdominis plane under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Group C - Caudal Epidural Block | Experimental | Participants in this group received a caudal epidural block after the induction of general anesthesia. A 35-mm 22G or 30-mm 25G block needle was inserted through the sacrococcygeal ligament into the epidural space under aseptic conditions. After confirming negative aspiration for cerebrospinal fluid or blood, 1 mL/kg of 0.25% bupivacaine was administered. Receives: Procedure: Caudal Epidural Block; Drug: Bupivacaine 0.25% |
| Group T - Transversus Abdominis Plane (TAP) Block | Experimental | Participants in this group received an ultrasound-guided transversus abdominis plane (TAP) block after the induction of general anesthesia. A 22G, 50-mm insulated block needle was inserted using an in-plane technique under ultrasound guidance with a linear probe. The needle was advanced into the fascial plane between the internal oblique and transversus abdominis muscles. After confirming placement with a 0.5-1 mL test dose of 0.9% NaCl and negative aspiration for blood, 0.3 mL/kg of 0.25% bupivacaine was administered. Receives: Procedure: Transversus Abdominis Plane (TAP) Block; Drug: Bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative FLACC Pain Scores
Postoperative pain intensity was measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at predefined time points after surgery. The FLACC scale is a validated tool for assessing postoperative pain in pediatric patients based on behavioral observations.
Measured: FLACC pain scores were recorded at 2, 6, 12, and 24 hours postoperatively
Secondary outcomes (4)
Total Postoperative Analgesic Consumption
The total amount of rescue analgesia (paracetamol, NSAIDs, opioids) administered in the first 24 hours postoperatively was recorded. This includes any additional medication given based on the patient's pain score.
Measured: 0-24 hours postoperatively
Intraoperative Hemodynamic Stability
Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and arterial oxygen saturation (SpO₂) were recorded at predefined intraoperative time points to assess the hemodynamic effects of the regional anesthesia techniques.
Measured: Baseline, after induction, after surgical incision, and at 15, 30, 45, and 60 minutes intraoperatively.
Incidence of Postoperative Nausea and Vomiting (PONV)
The number of patients experiencing postoperative nausea and vomiting (PONV) within the first 24 hours was recorded.
Measured: 0-24 hours postoperatively
Parental Satisfaction Scores
Parental satisfaction with their child's postoperative pain management was assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied).
Measured: Recorded at 24 hours postoperatively and at a follow-up phone call after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start15 Dec 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study compares two regional anesthesia techniques for postoperative analgesia in pediatric patients undergoing infraumbilical surgery. Participants were randomized into two groups: Group C (Caudal Block) and Group T (TAP Block). Pain scores, analgesic consumption, and adverse effects were compared.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Baran, Namik Kemal University
- Investigators
- Onur Baran, Study chair, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895382
- Sponsor's protocol ID
- TNKU-PED-ANES-2022-001
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Caudal Epidural Block and Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Pediatric Infraumbilical Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06895382
- Acronym / sponsor ID
- TNKU-PED-ANES-2022-001
- Conditions
- Postoperative Pain, Pediatric Surgery, Anesthesia, Local, Regional Anesthesia, Abdominal Surgery
- Keywords
- Caudal Epidural Block, Transversus Abdominis Plane Block, Pediatric Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 26 Mar 2025 (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.
This randomized controlled trial investigates the postoperative analgesic efficacy of caudal epidural block versus ultrasound-guided transversus abdominis plane (TAP) block in pediatric patients undergoing infraumbilical surgery.
A total of 60 pediatric patients (aged 1 to 7 years, ASA I-II) were randomly assigned to one of two groups:
- Group C (Caudal Block): Received 1 mL/kg of 0.25% bupivacaine in the caudal epidural space.
- Group T (TAP Block): Received 0.3 mL/kg of 0.25% bupivacaine injected into the transversus abdominis plane under ultrasound guidance.
Primary Outcome:
- Postoperative FLACC pain scores at 2, 6, 12, and 24 hours.
Secondary Outcomes:
- Total analgesic consumption (including rescue analgesia).
- Intraoperative hemodynamic parameters (heart rate, blood pressure, SpO₂).
- Incidence of nausea and vomiting (PONV).
- Parental satisfaction scores.
The study aims to determine which regional anesthesia technique provides superior pain relief and reduces systemic analgesic requirements in pediatric patients.
Detailed description
Postoperative pain management in pediatric patients is a challenge due to difficulties in pain assessment and concerns about opioid-related adverse effects. While caudal epidural block has traditionally been the standard of care for infraumbilical pediatric surgeries, ultrasound-guided transversus abdominis plane (TAP) block has emerged as a promising alternative with the potential for longer-lasting analgesia and fewer motor block complications.
This randomized controlled trial was conducted at Tekirdağ Namık Kemal University Hospital between December 2022 and December 2023. A total of 60 pediatric patients (aged 1-7 years, ASA I-II) undergoing infraumbilical surgery were enrolled and randomly assigned to receive either:
- Caudal epidural block (1 mL/kg of 0.25% bupivacaine via the sacral hiatus).
- TAP block (0.3 mL/kg of 0.25% bupivacaine in the fascial plane between the internal oblique and transversus abdominis muscles under ultrasound guidance).
General anesthesia was induced using sevoflurane inhalation, followed by propofol (2-3 mg/kg) and fentanyl (1 µg/kg) for IV induction. A laryngeal mask airway (LMA) was used, and anesthesia was maintained with sevoflurane at a MAC of 1.0%.
Outcome Measures:
- Primary Outcome:
- FLACC pain scores at 2, 6, 12, and 24 hours postoperatively.
- Secondary Outcomes:
- Total postoperative analgesic consumption (including rescue analgesia).
- Hemodynamic parameters (HR, SBP, DBP, SpO₂) recorded at predefined intraoperative time points.
- Incidence of postoperative nausea and vomiting (PONV).
- Parental satisfaction scores collected post-discharge.
Statistical Analysis:
Data were analyzed using SPSS 25.0. Sample size was determined using G*Power 3.1.9.2, with an effect size (d) of 0.75, power of 0.80, and Type I error of 0.05. The study followed randomized allocation with blinding of pain assessors.
This study aims to determine whether TAP block provides equivalent or superior analgesia compared to caudal epidural block in pediatric patients undergoing infraumbilical surgeries. Findings will help guide future pediatric regional anesthesia protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study compares two regional anesthesia techniques for postoperative analgesia in pediatric patients undergoing infraumbilical surgery. Participants were randomized into two groups: Group C (Caudal Block) and Group T (TAP Block). Pain scores, analgesic consumption, and adverse effects were compared.
| Arm | Type | Receives |
|---|---|---|
| Group C - Caudal Epidural Block | Experimental | Procedure: Caudal Epidural Block, Drug: Bupivacaine 0.25%Participants in this group received a caudal epidural block after the induction of general anesthesia. A 35-mm 22G or 30-mm 25G block needle was inserted through the sacrococcygeal ligament into the epidural space under aseptic conditions. After confirming negative aspiration for cerebrospinal fluid or blood, 1 mL/kg of 0.25% bupivacaine was administered. |
| Group T - Transversus Abdominis Plane (TAP) Block | Experimental | Procedure: Transversus Abdominis Plane (TAP) Block, Drug: Bupivacaine 0.25%Participants in this group received an ultrasound-guided transversus abdominis plane (TAP) block after the induction of general anesthesia. A 22G, 50-mm insulated block needle was inserted using an in-plane technique under ultrasound guidance with a linear probe. The needle was advanced into the fascial plane between the internal oblique and transversus abdominis muscles. After confirming placement with a 0.5-1 mL test dose of 0.9% NaCl and negative aspiration for blood, 0.3 mL/kg of 0.25% bupivacaine was administered. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged 1 to 7 years.
- ASA Physical Status I-II.
- Undergoing infraumbilical abdominal surgery (e.g., hernia repair, orchiopexy, circumcision).
- Parental written informed consent obtained.
Key exclusion criteria (8 listed)
- Contraindications to regional anesthesia, such as:
- Coagulopathy or bleeding disorders.
- Local infection at the injection site.
- Known allergy to local anesthetics.
- Neurological conditions (e.g., degenerative neuropathy, brain tumors, increased intracranial pressure).
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 |
|---|---|---|
| Caudal Epidural BlockAlso: Caudal Block, Caudal AnesthesiaA caudal epidural block was performed after the induction of general anesthesia. Using a 35-mm 22G or 30-mm 25G block needle, the sacral hiatus was identified, and the needle was inserted through the sacrococcygeal ligament into the epidural space under aseptic conditions. After confirming negative aspiration for cerebrospinal fluid or blood, 1 mL/kg of 0.25% bupivacaine was administered. | Procedure or surgery | Group C - Caudal Epidural Block |
| Transversus Abdominis Plane (TAP) BlockAlso: TAP Block, Ultrasound-Guided TAP BlockA transversus abdominis plane (TAP) block was performed after the induction of general anesthesia. Using a 22G, 50-mm insulated block needle, the injection was administered under ultrasound guidance using a linear probe and in-plane technique. The needle was advanced into the fascial plane between the internal oblique and transversus abdominis muscles. After confirming placement with a 0.5-1 mL test dose of 0.9% NaCl and negative aspiration for blood, 0.3 mL/kg of 0.25% bupivacaine was administered. | Procedure or surgery | Group T - Transversus Abdominis Plane (TAP) Block |
| Bupivacaine 0.25%0.25% bupivacaine was administered in both intervention arms as part of the regional anesthesia procedure In the Caudal Block group, 1 mL/kg of 0.25% bupivacaine was administered into the caudal epidural space. In the TAP Block group, 0.3 mL/kg of 0.25% bupivacaine was administered into the transversus abdominis plane under ultrasound guidance | Drug | Group C - Caudal Epidural Block, Group T - Transversus Abdominis Plane (TAP) Block |
Primary outcome
Postoperative FLACC Pain Scores
Time frame: FLACC pain scores were recorded at 2, 6, 12, and 24 hours postoperatively
Postoperative pain intensity was measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at predefined time points after surgery. The FLACC scale is a validated tool for assessing postoperative pain in pediatric patients based on behavioral observations.
4 secondary outcomes
Total Postoperative Analgesic Consumption
Time frame: 0-24 hours postoperatively
Intraoperative Hemodynamic Stability
Time frame: Baseline, after induction, after surgical incision, and at 15, 30, 45, and 60 minutes intraoperatively.
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: 0-24 hours postoperatively
Parental Satisfaction Scores
Time frame: Recorded at 24 hours postoperatively and at a follow-up phone call after discharge.
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 1 Apr 2025.
- 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.
Onur Baran study chair
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal Epidural Block, Transversus Abdominis Plane (TAP) Block and Bupivacaine 0.25% in people with Postoperative Pain and Pediatric Surgery, run by Namik Kemal 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 4 inclusion and 8 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 1 Apr 2025. 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?
Postoperative FLACC Pain Scores (time frame: FLACC pain scores were recorded at 2, 6, 12, and 24 hours postoperatively). 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 1 Apr 2025.