AnalgesiaNCT06362811
Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies
A study testing Sacral Erector Spinae Plane Block in people with Analgesia and Pain, Acute, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia. Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Analgesia, Pain, Acute
- What is being tested?
- Sacral Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 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 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients undergoing only rectal biopsy
- ASA class I-II
Who cannot join
- ASA class III or more
- Coagulation disorders
- Sacral or spinal anatomical abnormalities
- Infection around the block site
- Local anesthesia allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul, 34098
About this study
Official title: Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies: A Prospective Randomized Controlled Trial
The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia.
Read the detailed description
Rectal biopsies in pediatric patients are performed under general anesthesia to obtain adequate tissue samples and optimize for patient comfort, well-being and safety. Post-operative pain can persist for longer than a day and requires analgesics. This study aimed to evaluate the effectiveness of sacral erector spinae block in decreasing post-operative pain scores and analgesic requirements.
- Conditions
- Analgesia, Pain, Acute
- Being tested
- Sacral Erector Spinae Plane Block
- Keywords
- Rectal Biopsy, Sacral Erector Spinae Block
- Medical subject headings
- Agnosia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral Erector Spinae Plane BlockProcedure or surgery
Also called Multifidus Plane Block
Ultrasound-guided bilateral injection of 1ml/kg 0.25% bupivacaine into the plane underneath the erector spinae muscles over sacral crests. The needle is inserted with in-plane technique from cranial to caudal direction over S3-4.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | No intervention | Patients will go under general anesthesia and receive only 1mcg/kg fentanyl and 10mg/kg paracetamol as analgesia intraoperatively |
| General anesthesia + Sacral ESP block | Active comparator | Patients will go under general anesthesia, receive only 1mcg/kg fentanyl and 10mg/kg paracetamol intraoperatively, and bilateral sacral ESP block Receives: Procedure: Sacral Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores
Children's and Infant's Postoperative Pain Scale (CHIPPS) assessment of postoperative pain (Scores between 0 and 3 indicate no pain, and scores above 4 indicate the need for pain management.)( minimum score is 0, maximum score is 10)
Measured: Postoperative 30th minute, 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour
Analgesia requirement
If CHIPPS(Children's and Infant's Postoperative Pain Scale- minimum score is 0, maximum score is 10) score > 4, patient will receive 1mg/kg tramadol during the first post-operative hour. If CHIPPS score > 4 after 1st hour, patient will receive 10mg/kg paracetamol initially and if further assessment 30 min later is still >4 patient will receive additional 1mg/kg tramadol
Measured: Post operative 24 hours
Secondary outcomes (1)
Complications
Presence of nausea, vomiting, apnea, hypotension, bradycardia, urinary retention and other
Measured: Post-operative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pinar kendigelen, Istanbul University - Cerrahpasa
- Investigators
- Ayse C Tutuncu, MD, Study director, Istanbul University - CerrahpasaPinar Kendigelen, MD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362811
- Sponsor's protocol ID
- 483730
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piraccini E, Taddei S. Sacral multifidus plane block: The correct name for sacral erector spinae plane block. J Clin Anesth. 2020 Aug;63:109754. doi: 10.1016/j.jclinane.2020.109754. Epub 2020 Feb 28. No abstract available.
PubMed 32120194Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.
PubMed 30999197Oksuz G, Arslan M, Bilal B, Gisi G, Yavuz C. Ultrasound guided sacral erector spinae block for postoperative analgesia in pediatric anoplasty surgeries. J Clin Anesth. 2020 Mar;60:88. doi: 10.1016/j.jclinane.2019.08.006. Epub 2019 Sep 3. No abstract available.
PubMed 31491727
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06362811
- Acronym / sponsor ID
- 483730
- Conditions
- Analgesia, Pain, Acute
- Keywords
- Rectal Biopsy, Sacral Erector Spinae Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Apr 2024 (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.
The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia.
Detailed description
Rectal biopsies in pediatric patients are performed under general anesthesia to obtain adequate tissue samples and optimize for patient comfort, well-being and safety. Post-operative pain can persist for longer than a day and requires analgesics. This study aimed to evaluate the effectiveness of sacral erector spinae block in decreasing post-operative pain scores and analgesic requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | No intervention | –Patients will go under general anesthesia and receive only 1mcg/kg fentanyl and 10mg/kg paracetamol as analgesia intraoperatively |
| General anesthesia + Sacral ESP block | Active comparator | Procedure: Sacral Erector Spinae Plane BlockPatients will go under general anesthesia, receive only 1mcg/kg fentanyl and 10mg/kg paracetamol intraoperatively, and bilateral sacral ESP block |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients undergoing only rectal biopsy
- ASA class I-II
Key exclusion criteria (5 listed)
- ASA class III or more
- Coagulation disorders
- Sacral or spinal anatomical abnormalities
- Infection around the block site
- Local anesthesia allergy
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 |
|---|---|---|
| Sacral Erector Spinae Plane BlockAlso: Multifidus Plane BlockUltrasound-guided bilateral injection of 1ml/kg 0.25% bupivacaine into the plane underneath the erector spinae muscles over sacral crests. The needle is inserted with in-plane technique from cranial to caudal direction over S3-4. | Procedure or surgery | General anesthesia + Sacral ESP block |
Primary outcome
Postoperative pain scores
Time frame: Postoperative 30th minute, 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour
Children's and Infant's Postoperative Pain Scale (CHIPPS) assessment of postoperative pain (Scores between 0 and 3 indicate no pain, and scores above 4 indicate the need for pain management.)( minimum score is 0, maximum score is 10)
Analgesia requirement
Time frame: Post operative 24 hours
If CHIPPS(Children's and Infant's Postoperative Pain Scale- minimum score is 0, maximum score is 10) score > 4, patient will receive 1mg/kg tramadol during the first post-operative hour. If CHIPPS score > 4 after 1st hour, patient will receive 10mg/kg paracetamol initially and if further assessment 30 min later is still >4 patient will receive additional 1mg/kg tramadol
1 secondary outcome
Complications
Time frame: Post-operative 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 16 Apr 2024.
- Background: PubMed 32120194Piraccini E, Taddei S. Sacral multifidus plane block: The correct name for sacral erector spinae plane block. J Clin Anesth. 2020 Aug;63:109754. doi: 10.1016/j.jclinane.2020.109754. Epub 2020 Feb 28. No abstract available.
- Background: PubMed 30999197Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.
- Background: PubMed 31491727Oksuz G, Arslan M, Bilal B, Gisi G, Yavuz C. Ultrasound guided sacral erector spinae block for postoperative analgesia in pediatric anoplasty surgeries. J Clin Anesth. 2020 Mar;60:88. doi: 10.1016/j.jclinane.2019.08.006. Epub 2019 Sep 3. No abstract available.
- 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.
Ayse C Tutuncu, MD study director
Istanbul University - Cerrahpasa
Pinar Kendigelen, MD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Erector Spinae Plane Block in people with Analgesia and 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 2 inclusion and 5 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 16 Apr 2024. 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 pain scores (time frame: Postoperative 30th minute, 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour). The study lists 2 primary outcomes in all. 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 NCT06362811, 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 16 Apr 2024.