Anesthesia, LocalNCT04444635
Serratus Anterior Plane Block in Pediatric Patients
A study testing Serratus Anterior Plan Block+ Fentanyl infusion and Fentanyl in people with Anesthesia, Local, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane block in pediatric patients undergoing thoracic surgeries. It is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Serratus Anterior Plan Block+ Fentanyl infusion and Fentanyl
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2020to 20 Jun 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 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6 months-3 years.
- American Society of anesthesiology (ASA) I and II.
- Pediatric patients undergoing thoracic surgeries (with anterior thoracotomy incision).
Who cannot join
- Patients whose parents or legal guardians refusing to participate.
- Preoperative mechanical ventilation.
- Known or suspected coagulopathy.
- Infection at the site of injection.
- Known or suspected allergy to any of the studied drugs.
- Elevated liver enzymes more than the normal values.
- Procedures with anticipated significant hemodynamic stability.
- Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen (BUN) more than 20mg/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgeries: A Randomized Controlled Trial
The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane block in pediatric patients undergoing thoracic surgeries.
It is a randomized controlled trial.
Read the detailed description
It is a prospective randomized controlled study. It is designed to estimate and compare the analgesic effect of single shot serratus anterior plane block in pediatric patients undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the control group. Our primary outcome will be the total dose of intra-operative fentanyl boluses.
Randomization will be achieved by using an online random number generator. Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the serratus anterior plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
- Conditions
- Anesthesia, Local
- Being tested
- Serratus Anterior Plan Block+ Fentanyl infusion, Fentanyl
- Keywords
- Serratus anterior plane block, Pediatric, Thoracotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plan Block+ Fentanyl infusionProcedure or surgery
Also called Serratus Anterior Plan Block
After induction of anesthesia, the patients will be put on the lateral position with the diseased side up. A linear ultrasound transducer will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage.
Then counting down ribs till the fifth rib will be identified in the mid-axillary line. The following muscles will be identified overlying the fifth rib: the latissimus dorsi (superficial and posterior),teres major (superior) and serratus muscles (deep and inferior). Under complete sterile conditions, the needle (25 G needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. Then, 2 mg/kg of 0.25% bupivacaine will be injected with continuous ultrasound guidance. In addition to continuous fentanyl infusion
FentanylDrug
Continuous fentanyl infusion throughout the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Anterior Plan block plus fentanyl infusion | Active comparator | The patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion. Receives: Procedure: Serratus Anterior Plan Block+ Fentanyl infusion; Drug: Fentanyl |
| Fentanyl infusion only | Active comparator | The patient will receive fentanyl infusion only. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of postoperative operative fentanyl consumption in the first 24 hours.
The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated
Measured: 12 months
Secondary outcomes (5)
Total dosage of additional fentanyl boluses usage in micrograms intraoperatively
Total dosage of additional fentanyl boluses usage in micrograms intraoperatively
Measured: 12 months
First rescue analgesia
Time (in minutes) to 1st rescue analgesia (morphine) post operatively which will be defined to be the elapsed time between stoppage of fentanyl infusion and a patient FLACC score equal or more than 4.
Measured: 12 months
Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6.
Pain assessment at 30 min, 60 min, 2 hours, 4hours, 8hours postoperatively by FLACC score.
Measured: 12 months
Intra and postoperative heart rate.
Intra and postoperative heart rate.
Measured: 12 months
Intraoperative and postoperative systolic blood pressure.
Intraoperative and postoperative systolic blood pressure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start14 Jun 2020
- Primary completion10 Jun 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelaziz Ismail, Cairo University
- Investigators
- AHMED ISMAIL, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444635
- Sponsor's protocol ID
- N110-2020
- Status last verified
- Jun 2021
- First submitted
- 20 Jun 2020
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patients data are confidential
Publications
Lonnqvist PA, Morton NS. Postoperative analgesia in infants and children. Br J Anaesth. 2005 Jul;95(1):59-68. doi: 10.1093/bja/aei065. Epub 2005 Jan 21. No abstract available.
PubMed 15668207Senturk M, Ozcan PE, Talu GK, Kiyan E, Camci E, Ozyalcin S, Dilege S, Pembeci K. The effects of three different analgesia techniques on long-term postthoracotomy pain. Anesth Analg. 2002 Jan;94(1):11-5, table of contents. doi: 10.1213/00000539-200201000-00003.
PubMed 11772793Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
PubMed 11020770Rogers ML, Henderson L, Mahajan RP, Duffy JP. Preliminary findings in the neurophysiological assessment of intercostal nerve injury during thoracotomy. Eur J Cardiothorac Surg. 2002 Feb;21(2):298-301. doi: 10.1016/s1010-7940(01)01104-6.
PubMed 11825739Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PubMed 23923989
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block in Pediatric Patients Undergoing Thoracic Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04444635
- Acronym / sponsor ID
- N110-2020
- Conditions
- Anesthesia, Local
- Keywords
- Serratus anterior plane block, Pediatric, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Jun 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 23 Jun 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.
The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane block in pediatric patients undergoing thoracic surgeries.
It is a randomized controlled trial.
Detailed description
It is a prospective randomized controlled study. It is designed to estimate and compare the analgesic effect of single shot serratus anterior plane block in pediatric patients undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the control group. Our primary outcome will be the total dose of intra-operative fentanyl boluses.
Randomization will be achieved by using an online random number generator. Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the serratus anterior plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
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 plus fentanyl infusion | Active comparator | Procedure: Serratus Anterior Plan Block+ Fentanyl infusion, Drug: FentanylThe patients will receive serratus anterior block in addition to continous intraoperative fentanyl infusion. |
| Fentanyl infusion only | Active comparator | Drug: FentanylThe patient will receive fentanyl infusion only. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 6 months-3 years.
- American Society of anesthesiology (ASA) I and II.
- Pediatric patients undergoing thoracic surgeries (with anterior thoracotomy incision).
Key exclusion criteria (8 listed)
- Patients whose parents or legal guardians refusing to participate.
- Preoperative mechanical ventilation.
- Known or suspected coagulopathy.
- Infection at the site of injection.
- Known or suspected allergy to any of the studied drugs.
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 |
|---|---|---|
| Serratus Anterior Plan Block+ Fentanyl infusionAlso: Serratus Anterior Plan BlockAfter induction of anesthesia, the patients will be put on the lateral position with the diseased side up. A linear ultrasound transducer will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage. Then counting down ribs till the fifth rib will be identified in the mid-axillary line. The following muscles will be identified overlying the fifth rib: the latissimus dorsi (superficial and posterior),teres major (superior) and serratus muscles (deep and inferior). Under complete sterile conditions, the needle (25 G needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. Then, 2 mg/kg of 0.25% bupivacaine will be injected with continuous ultrasound guidance. In addition to continuous fentanyl infusion | Procedure or surgery | Serratus Anterior Plan block plus fentanyl infusion |
| FentanylContinuous fentanyl infusion throughout the surgical procedure. | Drug | Fentanyl infusion only, Serratus Anterior Plan block plus fentanyl infusion |
Primary outcome
The total dose of postoperative operative fentanyl consumption in the first 24 hours.
Time frame: 12 months
The total dose of postoperative operative fentanyl consumption in micrograms in the first 24 hours will be calculated
5 secondary outcomes
Total dosage of additional fentanyl boluses usage in micrograms intraoperatively
Time frame: 12 months
First rescue analgesia
Time frame: 12 months
Pain assessment postoperatively by Face, Leg, Activity, Cry, Consolability (FLACC) score, minimum is zero, and maximum is 6.
Time frame: 12 months
Intra and postoperative heart rate.
Time frame: 12 months
Intraoperative and postoperative systolic blood pressure.
Time frame: 12 months
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 25 Jun 2021.
- Background: PubMed 15668207Lonnqvist PA, Morton NS. Postoperative analgesia in infants and children. Br J Anaesth. 2005 Jul;95(1):59-68. doi: 10.1093/bja/aei065. Epub 2005 Jan 21. No abstract available.
- Background: PubMed 11772793Senturk M, Ozcan PE, Talu GK, Kiyan E, Camci E, Ozyalcin S, Dilege S, Pembeci K. The effects of three different analgesia techniques on long-term postthoracotomy pain. Anesth Analg. 2002 Jan;94(1):11-5, table of contents. doi: 10.1213/00000539-200201000-00003.
- Background: PubMed 11020770Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
- Background: PubMed 11825739Rogers ML, Henderson L, Mahajan RP, Duffy JP. Preliminary findings in the neurophysiological assessment of intercostal nerve injury during thoracotomy. Eur J Cardiothorac Surg. 2002 Feb;21(2):298-301. doi: 10.1016/s1010-7940(01)01104-6.
- Results publication: PubMed 23923989Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
- Individual participant dataSharing planned: No. The patients data are confidential
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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.
AHMED ISMAIL, Lecturer study director
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 Serratus Anterior Plan Block+ Fentanyl infusion and Fentanyl in people with Anesthesia, Local, 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 3 inclusion and 8 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 25 Jun 2021. 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?
The total dose of postoperative operative fentanyl consumption in the first 24 hours. (time frame: 12 months). 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 NCT04444635, which also lists 5 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 25 Jun 2021.