AnesthesiaNCT04933877
Serratus Anterior Plane Block Versus Erector Spinae Plane Block. for Thoracotomy in Pediatric Patients
A study testing Fascial plane block in people with Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized controled trial is designed to compare efficacy and safty of serratus anterior plane block versus erector spinae plane block for thoracotomy in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Fascial plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to Apr 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1 to 10-year-old
- ASA I, II, and II
Who cannot join
- Patients whose parents or legal guardians refusing to participate.
- Preoperative mechanical ventilation.
- Preoperative inotropic drug infusion.
- Known or suspected coagulopathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Misr University For Science And Technology
Giza, 11562
Ahmed Kareem, Ass. prof., 00201009750511, dr.ahmedkar@gmail.com
About this study
Official title: Serratus Anterior Plane Block Versus Erector Spinae Plane Block For Thoracotomy In Pediatric Patients: a Randomised Clinical Trial
This randomized controled trial is designed to compare efficacy and safty of serratus anterior plane block versus erector spinae plane block for thoracotomy in pediatric patients.
- Conditions
- Anesthesia
- Being tested
- Fascial plane block
- Keywords
- Erector spinae block, Pediatric, serratus anterior plane block, Thoracotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial plane blockProcedure or surgery
Serratus anterior plane block
| Study group | Role | What they receive |
|---|---|---|
| Serratus Anterior Plan block | Active comparator | The SAPB was performed in the operative room (OR) after anesthesia induction using the same ultrasound machine (SonoSite) and linear ultrasound transducer 8- 12 Hz. The patient was positioned in a lateral position with the operative side up and arm flexed forward; then, a linear ultrasound transducer was placed in a sagittal plane over the mid-clavicular line of the thoracic cage. Then, moving inferior-lateral direction till the fifth rib was identified in the mid-axillary line. The following structures were recognized: the rib, pleura, teres major muscle (superior), latissimus dorsi muscle (superficial and posterior), and serratus muscles muscle (deep and inferior). Under complete sterile conditions, a 22-gauge echogenic needle was introduced in-plane with respect to the ultrasound probe targeting the plane deep to the serratus anterior muscle. Then, 0.4 ml/kg of 0.25% bupivacaine was injected with continuous ultrasound guidance. Receives: Procedure: Fascial plane block |
| Erector spinae plane block | Active comparator | Patients in Group ESPB receive US erector spinae plane block by injecting 0.4ml/kg (bupivacaine 0.25%). Under strict aseptic precautions, The T3 spinous process is located by palpating and counting down from the C7 spinous process. A high-frequency 12 MHz linear ultrasound transducer is placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process. Three muscles; trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.Using an in-plane approach a 22 G needle is inserted in caudal-cephalad direction until the tip is deep to erector spinae muscle. Correct needle tip location is confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread (i.e., hydrodissection) in the fascial plane between the erector spinae muscle and the transverse process. Then, bupivacaine is injected, and visualizing the fascial plane. Receives: Procedure: Fascial plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative fentanyl consumption
amount of fentanyl in mic consumed in the 24 hours postoperatively
Measured: 9 month
Secondary outcomes (7)
intraoperative fentanyl consumption
total dose of fentanyl given during the surgical procedure
Measured: 24 hours
FLACC score at 1,2,4,8,12,24 hours postoperatively
FLACC score ( Face Leg Activity Cry Consolability ) it is pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score.
each point is given score between 0 and 2. the maximum score is 10 the lowest is 0
Measured: 24 hours
patient satisfaction
satisfaction in numeric scale from1 to 5. 1 express the worst, and 5 express the best.
Measured: 24 hours
RASS score
sedation score
Measured: 24 hours
time of first rescue analgesi
duration of postoperative analgesia
Measured: 24 hours
Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively.
Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively.
Measured: 24 hours
PONV
post operative nausea and vomiting
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 posted22 Jun 2021
- Study start1 Mar 2021
- Primary completionFeb 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology
- Responsible party
- Principal investigator, Ahmed Abdelaziz Ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933877
- Sponsor's protocol ID
- N5098-2021
- Status last verified
- Oct 2022
- First submitted
- 8 Jun 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is a confidential issue according to the policy of my institute.
Publications
Gaballah KM, Soltan WA, Bahgat NM. Ultrasound-Guided Serratus Plane Block Versus Erector Spinae Block for Postoperative Analgesia After Video-Assisted Thoracoscopy: A Pilot Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1946-1953. doi: 10.1053/j.jvca.2019.02.028. Epub 2019 Feb 21.
PubMed 30930141Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.
PubMed 32660716
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block Versus Erector Spinae Plane Block For Thoracotomy In Pediatric Patients: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04933877
- Acronym / sponsor ID
- N5098-2021
- Conditions
- Anesthesia
- Keywords
- Erector spinae block, Pediatric, serratus anterior plane block, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 22 Jun 2021 (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 controled trial is designed to compare efficacy and safty of serratus anterior plane block versus erector spinae plane block for thoracotomy in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Anterior Plan block | Active comparator | Procedure: Fascial plane blockThe SAPB was performed in the operative room (OR) after anesthesia induction using the same ultrasound machine (SonoSite) and linear ultrasound transducer 8- 12 Hz. The patient was positioned in a lateral position with the operative side up and arm flexed forward; then, a linear ultrasound transducer was placed in a sagittal plane over the mid-clavicular line of the thoracic cage. Then, moving inferior-lateral direction till the fifth rib was identified in the mid-axillary line. The following structures were recognized: the rib, pleura, teres major muscle (superior), latissimus dorsi muscle (superficial and posterior), and serratus muscles muscle (deep and inferior). Under complete sterile conditions, a 22-gauge echogenic needle was introduced in-plane with respect to the ultrasound probe targeting the plane deep to the serratus anterior muscle. Then, 0.4 ml/kg of 0.25% bupivacaine was injected with continuous ultrasound guidance. |
| Erector spinae plane block | Active comparator | Procedure: Fascial plane blockPatients in Group ESPB receive US erector spinae plane block by injecting 0.4ml/kg (bupivacaine 0.25%). Under strict aseptic precautions, The T3 spinous process is located by palpating and counting down from the C7 spinous process. A high-frequency 12 MHz linear ultrasound transducer is placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process. Three muscles; trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.Using an in-plane approach a 22 G needle is inserted in caudal-cephalad direction until the tip is deep to erector spinae muscle. Correct needle tip location is confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread (i.e., hydrodissection) in the fascial plane between the erector spinae muscle and the transverse process. Then, bupivacaine is injected, and visualizing the fascial plane. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 1 to 10-year-old
- ASA I, II, and II
Key exclusion criteria (4 listed)
- Patients whose parents or legal guardians refusing to participate.
- Preoperative mechanical ventilation.
- Preoperative inotropic drug infusion.
- Known or suspected 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 |
|---|---|---|
| Fascial plane blockSerratus anterior plane block | Procedure or surgery | Erector spinae plane block, Serratus Anterior Plan block |
Primary outcome
post-operative fentanyl consumption
Time frame: 9 month
amount of fentanyl in mic consumed in the 24 hours postoperatively
7 secondary outcomes
intraoperative fentanyl consumption
Time frame: 24 hours
FLACC score at 1,2,4,8,12,24 hours postoperatively
Time frame: 24 hours
patient satisfaction
Time frame: 24 hours
RASS score
Time frame: 24 hours
time of first rescue analgesi
Time frame: 24 hours
Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively.
Time frame: 24 hours
PONV
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 30930141Gaballah KM, Soltan WA, Bahgat NM. Ultrasound-Guided Serratus Plane Block Versus Erector Spinae Block for Postoperative Analgesia After Video-Assisted Thoracoscopy: A Pilot Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1946-1953. doi: 10.1053/j.jvca.2019.02.028. Epub 2019 Feb 21.
- Results publication: PubMed 32660716Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.
- Individual participant dataSharing planned: No. IPD is a confidential issue according to the policy of my institute.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial plane block in people with Anesthesia, run by Cairo University 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: status not confirmed, as of the sponsor's last update on 13 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative fentanyl consumption (time frame: 9 month). 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 NCT04933877, which also lists 2 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 13 Oct 2022.