CircumcisionNCT05284734
Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia
A study testing Regional anesthesia intervention in people with Circumcision and Lower Abdominal Surgery, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer… Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Lower Abdominal Surgery
- What is being tested?
- Regional anesthesia intervention
- Type of treatment
- 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
- 1 Jan 2021to 15 Dec 2021
- 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
- 1-7 years of age
- ASA (American Society of Anesthesiologists) I-II group
- Scheduled for circumcision and unilateral lower abdominal surgery at the same session
- Able to communicate in Turkish
- Willing to participate to the study (parents and children)
Who cannot join
- Less than 1 or more than 7 years of age
- A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital lumbar anomaly, liver and/or kidney disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
- Unwilling to to participate to the study ((parents or children)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, 34384
About this study
Official title: Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia in Circumcision and Lower Abdominal Surgery in Pediatric Patients: A Double-blind, Randomized Controlled Trial
Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients.
Read the detailed description
Circumcision and any lower abdominal surgery in the pediatric population result in a very painful postoperative period, even when each procedure is evaluated separately. Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients. As far as we know, there is no previous study in the literature comparing CB and ESP block in pediatric patients.
- Conditions
- Circumcision, Lower Abdominal Surgery
- Being tested
- Regional anesthesia intervention
- Keywords
- Ultrasound, Pain, Caudal block, Erector spinae block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesia interventionProcedure or surgery
Ultrasound-guided caudal and erector spinae blocks were administered
| Study group | Role | What they receive |
|---|---|---|
| Caudal block group | Experimental | A 22 gauge 50 mm echogenic block needle placed through the sacrococcygeal membrane into the sacral canal in the longitudinal position, using the in-plane technique Negative aspiration was then performed 0.125% bupivacaine at a dose of 1 ml/kg was administered Receives: Procedure: Regional anesthesia intervention |
| Erector spinae block group | Experimental | The erector spinae muscle and the transverse process were identified, and a 22 G, 80 mm echogenic block needle was advanced towards the transverse process until contact. Following hydrodissection, 1 ml/kg of 0.125% bupivacaine was injected deep into the erector spinae muscle Receives: Procedure: Regional anesthesia intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Postoperative pain
It was assessed seven times after the operation with Face, Legs, Activity, Cry, Consolability (FLACC) scale. The lowest scale score is 0 points and the highest 10 points.
Following transfer from the recovery unit to the ward, the 1st, 2nd, 4th, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse.
Measured: Up to 24 hours
Secondary outcomes (2)
Time of Postoperative analgesic requirement
It was assessed seven times after the operation with Face, Legs, Activity, Cry, Consolability (FLACC) scale. The lowest scale score is 0 points and the highest 10 points. Significant pain behavior for the scale has been identified as 4 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse. Paracetamol was administered IV at a dose of 10 mg/kg if the scale score was 4 or higher.
Measured: Up to 24 hours
Rate of Postoperative complications
Urinary retention, hematoma, ecchymosis, motor block were postoperative complications. They were assessed by an anesthesiologist.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jan 2021
- Primary completion30 Nov 2021
- Study completion15 Dec 2021
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 CircumcisionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Ozen, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Volkan Özen, Asso.Prof., Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284734
- Sponsor's protocol ID
- 2021.42
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.
PubMed 30868029Ozen V, Yigit D. A Comparison of the Postoperative Analgesic Effectiveness of Ultrasound-Guided Dorsal Penile Nerve Block and Ultrasound-Guided Pudendal Nerve Block in Circumcision. Urol Int. 2020;104(11-12):871-877. doi: 10.1159/000509173. Epub 2020 Aug 13.
PubMed 32791500Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.
PubMed 32507565Ozen V, Turan EI, Kirdan T, Ayas TA, Erten E, Karacalar S. Erector spinae plane block as an alternative to caudal block in concurrent pediatric urologic and inguinal surgery: A double-blinded randomized controlled trial. Medicine (Baltimore). 2025 Apr 11;104(15):e42109. doi: 10.1097/MD.0000000000042109.
PubMed 40228275
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia in Circumcision and Lower Abdominal Surgery in Pediatric Patients: A Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05284734
- Acronym / sponsor ID
- 2021.42
- Conditions
- Circumcision, Lower Abdominal Surgery
- Keywords
- Ultrasound, Pain, Caudal block, Erector spinae block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 17 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.
Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients.
Detailed description
Circumcision and any lower abdominal surgery in the pediatric population result in a very painful postoperative period, even when each procedure is evaluated separately. Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients. As far as we know, there is no previous study in the literature comparing CB and ESP block in pediatric patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal block group | Experimental | Procedure: Regional anesthesia interventionA 22 gauge 50 mm echogenic block needle placed through the sacrococcygeal membrane into the sacral canal in the longitudinal position, using the in-plane technique Negative aspiration was then performed 0.125% bupivacaine at a dose of 1 ml/kg was administered |
| Erector spinae block group | Experimental | Procedure: Regional anesthesia interventionThe erector spinae muscle and the transverse process were identified, and a 22 G, 80 mm echogenic block needle was advanced towards the transverse process until contact. Following hydrodissection, 1 ml/kg of 0.125% bupivacaine was injected deep into the erector spinae muscle |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1-7 years of age
- ASA (American Society of Anesthesiologists) I-II group
- Scheduled for circumcision and unilateral lower abdominal surgery at the same session
- Able to communicate in Turkish
- Willing to participate to the study (parents and children)
Key exclusion criteria (3 listed)
- Less than 1 or more than 7 years of age
- A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital lumbar anomaly, liver and/or kidney disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
- Unwilling to to participate to the study ((parents or children)
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 |
|---|---|---|
| Regional anesthesia interventionUltrasound-guided caudal and erector spinae blocks were administered | Procedure or surgery | Caudal block group, Erector spinae block group |
Primary outcome
Level of Postoperative pain
Time frame: Up to 24 hours
It was assessed seven times after the operation with Face, Legs, Activity, Cry, Consolability (FLACC) scale. The lowest scale score is 0 points and the highest 10 points. Following transfer from the recovery unit to the ward, the 1st, 2nd, 4th, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse.
2 secondary outcomes
Time of Postoperative analgesic requirement
Time frame: Up to 24 hours
Rate of Postoperative complications
Time frame: Up to 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 Mar 2022.
- Background: PubMed 30868029Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.
- Background: PubMed 32791500Ozen V, Yigit D. A Comparison of the Postoperative Analgesic Effectiveness of Ultrasound-Guided Dorsal Penile Nerve Block and Ultrasound-Guided Pudendal Nerve Block in Circumcision. Urol Int. 2020;104(11-12):871-877. doi: 10.1159/000509173. Epub 2020 Aug 13.
- Background: PubMed 32507565Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.
- Derived from this study: PubMed 40228275Ozen V, Turan EI, Kirdan T, Ayas TA, Erten E, Karacalar S. Erector spinae plane block as an alternative to caudal block in concurrent pediatric urologic and inguinal surgery: A double-blinded randomized controlled trial. Medicine (Baltimore). 2025 Apr 11;104(15):e42109. doi: 10.1097/MD.0000000000042109.
- 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.
Volkan Özen, Asso.Prof. principal investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional anesthesia intervention in people with Circumcision and Lower Abdominal Surgery, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 5 inclusion and 3 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 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?
Level of Postoperative pain (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 NCT05284734, 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 Mar 2022.