Post Operative PainNCT05896072
Comparison of Two Different Analgesic Regional Block Techniques in Pediatric Patients Undergoing a Hernia Repair
A study testing Erector Spinae Plane Block and Caudal Block in people with Post Operative Pain and Inguinal Hernia, run by Abant Izzet Baysal University at 7 sites in Turkey (Türkiye).
Trial summary
Lower abdominal operations; especially inguinal hernia repairs are one of the most frequently performed operations in the daily practice of pediatric surgeries.Regional anesthesia techniques are frequently and effectively used methods in postoperative pain control. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Post Operative Pain, Inguinal Hernia
- What is being tested?
- Erector Spinae Plane Block and Caudal Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesTurkey (Türkiye)
- Study dates
- 8 May 2023to 31 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patient scheduled for unilateral elective inguinal hernia operation
- ASA status 1-2
Who cannot join
- Pediatric patient's parents refusal
- Contraindications to regional anesthesia
- Known allergy to local anesthetics,
- Bleeding diathesis,
- Severe kidney or liver disease
- Presence of infection at the needle entry site.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Abant İzzet Baysal Education and Training Hospital
Bolu, Merkez
- Recruiting
Bolu Abant İzzet Baysal Medical School
Bolu, 14030
Ilker Ital, MD, (0374) 253 46 56, ilkerital@gmail.com
- Recruiting
Bolu Abant İzzet Baysal University Faculty of Medicine
Bolu, 14030
Ilker Ital, MD, +905337723300, ilkerital@gmail.com
Tacettin Ayanoglu, MD, +905312331970 ext. İtal, ilkerital@gmail.com
- Recruiting
Karabuk University Karabuk Training and Research Hospital
Karabük, 78100
Kenan Kart, MD, +90 5063849983, kenankart@karabuk.edu.tr
Duygu Taskin, MD, +90 5386606553, duygutaskin@karabuk.edu.tr
- Recruiting
Karabuk University Training and Research Hospital
Karabük, 78100
Kenan Kart, MD, +90 5063849983, kenankart@karabuk.edu.tr
Duygu Taskin, MD, +90 5386606553, duygutaskin@karabuk.edu.tr
- Recruiting
Karabuk University Training and Research Hospital
Karabük, 78100
Kenan Kart, MD, +90 5063849983, kenankart@karabuk.edu.tr
Duygu Taskin, MD, +90 5386606553, duygutaskin@karabuk.edu.tr
- Recruiting
Karabük University Training and Research Hospital
Karabük, 78100
Kenan Kart, MD, +90 5063849983, kenankart@karabuk.edu.tr
Duygu Taskin, MD, +90 5386606553, duygutaskin@karabuk.edu.tr
About this study
Official title: Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Caudal Block on Postoperative Pain in Children Undergoing Unilateral Inguinal Hernia Operation
Lower abdominal operations; especially inguinal hernia repairs are one of the most frequently performed operations in the daily practice of pediatric surgeries.Regional anesthesia techniques are frequently and effectively used methods in postoperative pain control. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae plane block and caudal block in pediatric unilateral inguinal hernia operations
Read the detailed description
Patient mobilization and providing adequate analgesia are important components of perioperative care in the day case procedures.Providing adequate postoperative analgesia in the pediatric age group is also important in terms of future pain perception and the development of chronic pain in the next period. Regional anesthesia techniques are very effective and frequently used methods in pain control in children.While central blocks such as caudal epidural block, spinal block are frequently used in inguinal surgeries in children, they have been used in peripheral blocks and successful results have been obtained. Although central blocks are frequently used in the pediatric population, depending on the relevant surgical site, due to the difficulty of application and the capacity to create motor block, the peripheral blocks are among the alternative methods. Although ESP (Erector spinae plane) block is an interfascial plane block, anatomical studies support the idea that some of its clinical benefit may be due to its extension into the paravertebral and epidural space. Its use for pediatric abdominal surgeries has also been reported. Simple randomization will be used in randomization. With 5% margin of error, 80% Power, the standard effect size was determined as 0,72. Pediatric patients in the ASA I-II group, aged 1-8 years, who will undergo elective unilateral inguinal hernia operation under general anesthesia, will be sufficient to include n= 30 cases in each group.The investigators plan to conduct a prospective randomized controlled study for pediatric day case inguinal hernia surgeries. Oral midazolam (0.5 mg/kg) will be given to all children as premedication. After standard monitoring with pulse oximetry, electrocardiography and noninvasive blood pressure measurement in the operating room, anesthesia will be induced with air in 8% sevoflurane and 50% oxygen. Then, a 24-gauge intravenous (iv) cannula will be placed and 1 µg/kg fentanyl and 2-3 mg/kg propofol will be administered for anesthesia induction. The airway will be secured with the ProSeal laryngeal mask airway (Intravent-Orthofix, Maidenhead, UK). Anesthesia will be maintained with 50% nitrous oxide and 2% sevoflurane in oxygen. Additional opioid medication use during the operations will be recorded. At the end of the surgery, all patients will be given acetaminophen 10 mg/kg iv for postoperative analgesia. All blocks will be done after the airway is secured before the surgery begins. Patients will be placed in the side-lying position for ESP block. Following skin preparation with 10% povidone iodine, the ultrasound probe will be placed 1-2 cm lateral to the midline at the sacral level. L1 level will be determined by counting upwards from the sacrum. After identification of the erector spinae muscle (ESM) and the transverse process, a block needle will be inserted deep into the ESM in the cranio-caudal direction using an in-plane technique. Correct needle position will be confirmed by the application of 0.5-1 ml local anesthetic (LA). For block efficacy a pre-calculated dose (0.5 ml/kg) of 0.25% bupivacaine (maximum dose is limited to 20 ml) will be used. In the caudal group the patients will be placed in the side-lying position for the caudal block. The sacral cornues will be palpated and the block needle will be advanced at an angle of 45 degrees.After the needle hits the sacrum the angle will be reduced and retract few millimeters in the epidural space in the sacral canal. It will be checked that there is no blood and cerebrospinal fluid with negative aspiration. Bupivacaine will be administered at the same dose, at a dose of %0.25, 0.5 ml/kg (the maximum dose is limited to 20 ml). A pain nurse was scheduled to assess pain using the Face, Legs, Activity, Crying, and Consolability (FLACC) scores both in the postoperative recovery room and in the ward. FLACC scores will be recorded at 0, 1, 2, 4, 6, 12, and 24 hours postoperatively. Additional analgesia was planned according to the FLACC scores of the patients. If the FLACC score is between 2 and 4, acetaminophen 10 mg/kg iv was planned as additional analgesia in the ward, and tramadol 1 mg/kg iv was planned as an additional analgesic if the FLACC score was > 4. Patients can be discharged after 6 hours postoperatively. Parents will be informed about pain assessment and instructed to give 10 mg/kg oral acetaminophen if FLACC scores are between 2 and 4, and 7 mg/kg oral ibuprofen if FLACC scores are 4 or more. Analgesic requirements in the first 24 hours postoperatively, time to first analgesia, and parental satisfaction with analgesia provided will be recorded at postoperative follow-up visits by one of the anesthetists who are unfamiliar with the study groups. Parental satisfaction levels will be recorded as a numerical scale from 1 to 10; 1 will represent the lowest possible satisfaction level and 10 the highest satisfaction level.
- Conditions
- Post Operative Pain, Inguinal Hernia
- Being tested
- Erector Spinae Plane Block, Caudal Block
- Keywords
- Caudal block, Erector spinae block, Pediatric postoperative analgesia, Inguinal hernia
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Application of ultrasound-guided erector spinae plane block for perioperative analgesia for elective inguinal hernia repair. Erector spinae plane block will be administered under general anesthesia before the surgery
Drug: Bupivacaine (Block Drug)
For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc).
Caudal BlockProcedure or surgery
Also called Caudal Epidural Block
Application of caudal block for perioperative analgesia for elective inguinal hernia repair. The caudal block will be administered under general anesthesia before the surgery.
Drug: Bupivacaine (Block Drug)
0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for block performances
| Study group | Role | What they receive |
|---|---|---|
| ESP Group | Experimental | Erector Spinae Plane Block Group
Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks Receives: Procedure: Erector Spinae Plane Block |
| Caudal Group | Active comparator | Caudal Block Group
Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks Receives: Procedure: Caudal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
Opioid consumption, need for rescue analgesic
Measured: 24 Hour
Secondary outcomes (2)
The Face, Legs, Activity, Cry and Consolability (FLACC) scale for pediatric pain evaluation.
FLACC scale ( Face, legs, activity, cry and consolability scale) is an observational scale comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10.Pain severity will be assessed on the FLACC scale from 0 to 10. A score of zero will be considered no pain and a score of 10 will be considered the most severe pain.
Measured: 24 Hour
Parental Satisfaction Assessment
Satisfaction level of parents after pediatric will be saved as a numerical scale from 1 to 10; 1 will represent the lowest possible satisfaction level and 10 the highest satisfaction level.
Measured: 24 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start8 May 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Collaborators
- Karabuk University, Başakşehir Çam & Sakura City Hospital
- Responsible party
- Sponsor
- Investigators
- Kenan Kart, MD, Principal investigator, Karabuk University Training and Research HospitalKasım İlker İtal, Study director, Bolu Abant University HospitalDuygu Taskin, Study chair, Karabuk University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896072
- Sponsor's protocol ID
- AIBU-TF-AR-II-003
- Status last verified
- Jun 2023
- First submitted
- 4 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
PubMed 30851499Cosarcan SK, Mahli A. [Comparison of intraoperative and postoperative analgesic properties of ilioinguinal/iliohypogastric and sacral epidural block in pediatric unilateral inguinal hernia operations]. Agri. 2022 Jan;34(1):38-46. doi: 10.14744/agri.2021.48254. Turkish.
PubMed 34988963
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Caudal Block on Postoperative Pain in Children Undergoing Unilateral Inguinal Hernia Operation
- ClinicalTrials.gov ID
- NCT05896072
- Acronym / sponsor ID
- AIBU-TF-AR-II-003
- Conditions
- Post Operative Pain, Inguinal Hernia
- Keywords
- Caudal block, Erector spinae block, Pediatric postoperative analgesia, Inguinal hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Collaborators
- Karabuk University, Başakşehir Çam & Sakura City Hospital
- Study start
- 8 May 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jun 2023 (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.
Lower abdominal operations; especially inguinal hernia repairs are one of the most frequently performed operations in the daily practice of pediatric surgeries.Regional anesthesia techniques are frequently and effectively used methods in postoperative pain control. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae plane block and caudal block in pediatric unilateral inguinal hernia operations
Detailed description
Patient mobilization and providing adequate analgesia are important components of perioperative care in the day case procedures.Providing adequate postoperative analgesia in the pediatric age group is also important in terms of future pain perception and the development of chronic pain in the next period. Regional anesthesia techniques are very effective and frequently used methods in pain control in children.While central blocks such as caudal epidural block, spinal block are frequently used in inguinal surgeries in children, they have been used in peripheral blocks and successful results have been obtained. Although central blocks are frequently used in the pediatric population, depending on the relevant surgical site, due to the difficulty of application and the capacity to create motor block, the peripheral blocks are among the alternative methods. Although ESP (Erector spinae plane) block is an interfascial plane block, anatomical studies support the idea that some of its clinical benefit may be due to its extension into the paravertebral and epidural space. Its use for pediatric abdominal surgeries has also been reported. Simple randomization will be used in randomization. With 5% margin of error, 80% Power, the standard effect size was determined as 0,72. Pediatric patients in the ASA I-II group, aged 1-8 years, who will undergo elective unilateral inguinal hernia operation under general anesthesia, will be sufficient to include n= 30 cases in each group.The investigators plan to conduct a prospective randomized controlled study for pediatric day case inguinal hernia surgeries. Oral midazolam (0.5 mg/kg) will be given to all children as premedication. After standard monitoring with pulse oximetry, electrocardiography and noninvasive blood pressure measurement in the operating room, anesthesia will be induced with air in 8% sevoflurane and 50% oxygen. Then, a 24-gauge intravenous (iv) cannula will be placed and 1 µg/kg fentanyl and 2-3 mg/kg propofol will be administered for anesthesia induction. The airway will be secured with the ProSeal laryngeal mask airway (Intravent-Orthofix, Maidenhead, UK). Anesthesia will be maintained with 50% nitrous oxide and 2% sevoflurane in oxygen. Additional opioid medication use during the operations will be recorded. At the end of the surgery, all patients will be given acetaminophen 10 mg/kg iv for postoperative analgesia. All blocks will be done after the airway is secured before the surgery begins. Patients will be placed in the side-lying position for ESP block. Following skin preparation with 10% povidone iodine, the ultrasound probe will be placed 1-2 cm lateral to the midline at the sacral level. L1 level will be determined by counting upwards from the sacrum. After identification of the erector spinae muscle (ESM) and the transverse process, a block needle will be inserted deep into the ESM in the cranio-caudal direction using an in-plane technique. Correct needle position will be confirmed by the application of 0.5-1 ml local anesthetic (LA). For block efficacy a pre-calculated dose (0.5 ml/kg) of 0.25% bupivacaine (maximum dose is limited to 20 ml) will be used. In the caudal group the patients will be placed in the side-lying position for the caudal block. The sacral cornues will be palpated and the block needle will be advanced at an angle of 45 degrees.After the needle hits the sacrum the angle will be reduced and retract few millimeters in the epidural space in the sacral canal. It will be checked that there is no blood and cerebrospinal fluid with negative aspiration. Bupivacaine will be administered at the same dose, at a dose of %0.25, 0.5 ml/kg (the maximum dose is limited to 20 ml). A pain nurse was scheduled to assess pain using the Face, Legs, Activity, Crying, and Consolability (FLACC) scores both in the postoperative recovery room and in the ward. FLACC scores will be recorded at 0, 1, 2, 4, 6, 12, and 24 hours postoperatively. Additional analgesia was planned according to the FLACC scores of the patients. If the FLACC score is between 2 and 4, acetaminophen 10 mg/kg iv was planned as additional analgesia in the ward, and tramadol 1 mg/kg iv was planned as an additional analgesic if the FLACC score was > 4. Patients can be discharged after 6 hours postoperatively. Parents will be informed about pain assessment and instructed to give 10 mg/kg oral acetaminophen if FLACC scores are between 2 and 4, and 7 mg/kg oral ibuprofen if FLACC scores are 4 or more. Analgesic requirements in the first 24 hours postoperatively, time to first analgesia, and parental satisfaction with analgesia provided will be recorded at postoperative follow-up visits by one of the anesthetists who are unfamiliar with the study groups. Parental satisfaction levels will be recorded as a numerical scale from 1 to 10; 1 will represent the lowest possible satisfaction level and 10 the highest satisfaction level.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Group | Experimental | Procedure: Erector Spinae Plane BlockErector Spinae Plane Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks |
| Caudal Group | Active comparator | Procedure: Caudal BlockCaudal Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patient scheduled for unilateral elective inguinal hernia operation
- ASA status 1-2
Key exclusion criteria (6 listed)
- Pediatric patient's parents refusal
- Contraindications to regional anesthesia
- Known allergy to local anesthetics,
- Bleeding diathesis,
- Severe kidney or liver disease
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 |
|---|---|---|
| Erector Spinae Plane BlockApplication of ultrasound-guided erector spinae plane block for perioperative analgesia for elective inguinal hernia repair. Erector spinae plane block will be administered under general anesthesia before the surgery Drug: Bupivacaine (Block Drug) For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc). | Procedure or surgery | ESP Group |
| Caudal BlockAlso: Caudal Epidural BlockApplication of caudal block for perioperative analgesia for elective inguinal hernia repair. The caudal block will be administered under general anesthesia before the surgery. Drug: Bupivacaine (Block Drug) 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for block performances | Procedure or surgery | Caudal Group |
Primary outcome
Analgesic consumption
Time frame: 24 Hour
Opioid consumption, need for rescue analgesic
2 secondary outcomes
The Face, Legs, Activity, Cry and Consolability (FLACC) scale for pediatric pain evaluation.
Time frame: 24 Hour
Parental Satisfaction Assessment
Time frame: 24 Hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Results publication: PubMed 30851499Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
- Results publication: PubMed 34988963Cosarcan SK, Mahli A. [Comparison of intraoperative and postoperative analgesic properties of ilioinguinal/iliohypogastric and sacral epidural block in pediatric unilateral inguinal hernia operations]. Agri. 2022 Jan;34(1):38-46. doi: 10.14744/agri.2021.48254. Turkish.
- 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.
Kenan Kart, MD principal investigator
Karabuk University Training and Research Hospital
Kasım İlker İtal study director
Bolu Abant University Hospital
Duygu Taskin study chair
Karabuk University Training and Research Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Caudal Block in people with Post Operative Pain and Inguinal Hernia, run by Abant Izzet Baysal University at 7 sites 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 6 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenan Kart, MD (+905337723300, kenankart@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic consumption (time frame: 24 Hour). 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 NCT05896072, which also lists 3 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 9 Jun 2023.