Complete Heart BlockPhase 4NCT04931693
PECs Block for Pacemaker Insertion in Children
A Phase 4 study testing paracetamol and modifiedPECs block in people with Complete Heart Block, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 1 year to 9 years
- Conditions the study is for
- Complete Heart Block
- What is being tested?
- paracetamol and modifiedPECs block
- 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 Dec 2021to 20 Aug 2022
- Phase
- Phase 4
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- congenital or post-operative heart block.
Who cannot join
- ⦁ Redo patient
- History of allergic reactions to local anesthetics.
- Bleeding disorders with International Normalization Ratio( INR) > 1.5 and/or platelets < 50 000.
- Rash or signs of infection at the injection site.
- Emergency procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral Pacemaker Insertion in Children: Randomized Controlled Trial
Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial
Read the detailed description
BACKGROUND Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements and postoperative pain. Little is known about the utility of PECs in reducing pain and narcotic use after pacemaker (PM)placement in children. OBJECTIVE The purpose of this study was to determine whether PECs can decrease postoperative pain and opioid use after PM placement in children.
METHODS A single-center controlled trial of pediatric patients undergoing transvenous PM placement between 2020 and 2021 will be performed. Demographics, procedural variables, postoperative pain, and postoperative opioid usage will be compared between patients who undergone PECs and those who undergone conventional anesthetic (Control).
- Conditions
- Complete Heart Block
- Being tested
- paracetamol, modifiedPECs block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Also called perfalgan
iv post operative analgesia
modifiedPECs blockProcedure or surgery
Also called PECs 2 block
sonar guided pectoral nerve block
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg and atracurium top ups at a dose of 0.1mg/kg. every 30 minutes. Receives: Drug: paracetamol |
| PECs | Active comparator | Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request. Receives: Procedure: modifiedPECs block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.
pain score
Measured: immediate, 6,12 ,18 and 24 hours after intervention
Secondary outcomes (1)
Total consumption of opioids.
morphine dose
Measured: immediate, 6,12 ,18 and 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start20 Dec 2021
- Primary completion20 Jun 2022
- Study completion20 Aug 2022
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 Complete Heart BlockStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patient will be randomly assigned to two equal groups. conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg . and Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block .
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931693
- Sponsor's protocol ID
- MS-316-2020
- Status last verified
- Oct 2022
- First submitted
- 5 Jun 2021
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anderson R, Harukuni I, Sera V. Anesthetic considerations for electrophysiologic procedures. Anesthesiol Clin. 2013 Jun;31(2):479-89. doi: 10.1016/j.anclin.2013.01.005. Epub 2013 Feb 23.
PubMed 23711654Yang JK, Char DS, Motonaga KS, Navaratnam M, Dubin AM, Trela A, Hanisch DG, McFadyen G, Chubb H, Goodyer WR, Ceresnak SR. Pectoral nerve blocks decrease postoperative pain and opioid use after pacemaker or implantable cardioverter-defibrillator placement in children. Heart Rhythm. 2020 Aug;17(8):1346-1353. doi: 10.1016/j.hrthm.2020.03.009. Epub 2020 Mar 20.
PubMed 32201270Zheng T, Zhong Y, Zhang L, Cheng X, Hu J, Huang X, Zhan B. Ultrasound-Guided Pectoral Nerve Block for Cardiac Implantable Electronic Device Implantation: A Prospective Randomized Controlled Trial of Postprocedural Analgesic Benefit in an Asian Population. Anesthesiol Res Pract. 2026 Jun 4;2026:8742805. doi: 10.1155/anrp/8742805. eCollection 2026.
PubMed 42254071
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral Pacemaker Insertion in Children: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04931693
- Acronym / sponsor ID
- MS-316-2020
- Conditions
- Complete Heart Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 18 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.
Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial
Detailed description
BACKGROUND Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements and postoperative pain. Little is known about the utility of PECs in reducing pain and narcotic use after pacemaker (PM)placement in children. OBJECTIVE The purpose of this study was to determine whether PECs can decrease postoperative pain and opioid use after PM placement in children.
METHODS A single-center controlled trial of pediatric patients undergoing transvenous PM placement between 2020 and 2021 will be performed. Demographics, procedural variables, postoperative pain, and postoperative opioid usage will be compared between patients who undergone PECs and those who undergone conventional anesthetic (Control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The patient will be randomly assigned to two equal groups. conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg . and Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block .
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: paracetamolconventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg and atracurium top ups at a dose of 0.1mg/kg. every 30 minutes. |
| PECs | Active comparator | Procedure: modifiedPECs blockPectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request. |
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- congenital or post-operative heart block.
Key exclusion criteria (5 listed)
- ⦁ Redo patient
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 |
|---|---|---|
| paracetamolAlso: perfalganiv post operative analgesia | Drug | control |
| modifiedPECs blockAlso: PECs 2 blocksonar guided pectoral nerve block | Procedure or surgery | PECs |
Primary outcome
Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.
Time frame: immediate, 6,12 ,18 and 24 hours after intervention
pain score
1 secondary outcome
Total consumption of opioids.
Time frame: immediate, 6,12 ,18 and 24 hours after intervention
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 20 Oct 2022.
- Results publication: PubMed 23711654Anderson R, Harukuni I, Sera V. Anesthetic considerations for electrophysiologic procedures. Anesthesiol Clin. 2013 Jun;31(2):479-89. doi: 10.1016/j.anclin.2013.01.005. Epub 2013 Feb 23.
- Results publication: PubMed 32201270Yang JK, Char DS, Motonaga KS, Navaratnam M, Dubin AM, Trela A, Hanisch DG, McFadyen G, Chubb H, Goodyer WR, Ceresnak SR. Pectoral nerve blocks decrease postoperative pain and opioid use after pacemaker or implantable cardioverter-defibrillator placement in children. Heart Rhythm. 2020 Aug;17(8):1346-1353. doi: 10.1016/j.hrthm.2020.03.009. Epub 2020 Mar 20.
- Derived from this study: PubMed 42254071Zheng T, Zhong Y, Zhang L, Cheng X, Hu J, Huang X, Zhan B. Ultrasound-Guided Pectoral Nerve Block for Cardiac Implantable Electronic Device Implantation: A Prospective Randomized Controlled Trial of Postprocedural Analgesic Benefit in an Asian Population. Anesthesiol Res Pract. 2026 Jun 4;2026:8742805. doi: 10.1155/anrp/8742805. eCollection 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paracetamol and modifiedPECs block in people with Complete Heart Block, run by Kasr El Aini Hospital 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 1 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 20 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale. (time frame: immediate, 6,12 ,18 and 24 hours after intervention). 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 NCT04931693, 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 20 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.