PaediatricNCT04518215
Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery
A study testing Erector Spinae Plain Block and Intra-Venous Analgesia in people with Paediatric and Surgery, run by Nazmy Edward Seif at 1 site in Egypt.
Trial summary
Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining effective postoperative analgesia in the paediatric age group is very crucial in terms of future pain perception and chronic pain development. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Paediatric, Surgery, Analgesia
- What is being tested?
- Erector Spinae Plain Block and Intra-Venous Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2020to 15 Dec 2022
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I - II.
- Elective open upper abdominal surgeries, e.g., open cholecystectomy, splenectomy, pyeloplasty, renal cysts excision, partial or total nephrectomy.
Who cannot join
- Patient's next of kin refusal.
- Allergy to local anaesthetics.
- Infection at the site of injection.
- Coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery: A Randomized Controlled Study
Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining effective postoperative analgesia in the paediatric age group is very crucial in terms of future pain perception and chronic pain development. Erector Spinae Plane Block (ESPB) is an interfascial plane block characterized by its ease of application and low complication rates with the introduction of ultrasonography. The aim of this study is to investigate the analgesic effects of ESPB in this particular age-group.
- Conditions
- Paediatric, Surgery, Analgesia, Anesthesia
- Being tested
- Erector Spinae Plain Block, Intra-Venous Analgesia
- Keywords
- Erector spinae plain block, Ultrasound-guided, Paediatric, Upper abdominal surgery, Analgesia, Anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plain BlockProcedure or surgery
Patients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB.
Intra-Venous AnalgesiaProcedure or surgery
Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.
| Study group | Role | What they receive |
|---|---|---|
| ESPB group | Experimental | Erector Spinae Plain Block Receives: Procedure: Erector Spinae Plain Block; Procedure: Intra-Venous Analgesia |
| IV Analgesia group | Active comparator | Intra-Venous Analgesia Receives: Procedure: Intra-Venous Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tramadol consumption.
Total dose of Tramadol (measured in mg) given intra-venously to the patient post-operatively.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start20 Aug 2020
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PaediatricStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Atef K Salama, MD, Principal investigator, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo UniversityNazmy S Michael, MD, Study director, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518215
- Sponsor's protocol ID
- USESPBPUAS
- Status last verified
- Feb 2023
- First submitted
- 15 Aug 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04518215
- Acronym / sponsor ID
- USESPBPUAS
- Conditions
- Paediatric, Surgery, Analgesia, Anesthesia
- Keywords
- Erector spinae plain block, Ultrasound-guided, Paediatric, Upper abdominal surgery, Analgesia, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 19 Aug 2020 (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.
Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining effective postoperative analgesia in the paediatric age group is very crucial in terms of future pain perception and chronic pain development. Erector Spinae Plane Block (ESPB) is an interfascial plane block characterized by its ease of application and low complication rates with the introduction of ultrasonography. The aim of this study is to investigate the analgesic effects of ESPB in this particular age-group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB group | Experimental | Procedure: Erector Spinae Plain Block, Procedure: Intra-Venous AnalgesiaErector Spinae Plain Block |
| IV Analgesia group | Active comparator | Procedure: Intra-Venous AnalgesiaIntra-Venous Analgesia |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I - II.
- Elective open upper abdominal surgeries, e.g., open cholecystectomy, splenectomy, pyeloplasty, renal cysts excision, partial or total nephrectomy.
Key exclusion criteria (4 listed)
- Patient's next of kin refusal.
- Allergy to local anaesthetics.
- Infection at the site of injection.
- Coagulopathy.
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 Plain BlockPatients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB. | Procedure or surgery | ESPB group |
| Intra-Venous AnalgesiaPost-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4. | Procedure or surgery | ESPB group, IV Analgesia group |
Primary outcome
Tramadol consumption.
Time frame: 24 hours
Total dose of Tramadol (measured in mg) given intra-venously to the patient post-operatively.
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 9 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Atef K Salama, MD principal investigator
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Nazmy S Michael, MD study director
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo 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 Erector Spinae Plain Block and Intra-Venous Analgesia in people with Paediatric and Surgery, run by Nazmy Edward Seif at 1 site in Egypt.
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 4 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 9 Feb 2023. 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 Egypt. 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?
Tramadol consumption. (time frame: 24 hours). 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 9 Feb 2023.