Pectointercostal Fascial Plane BlockNCT05539885
Parasternal Block in Pediatric Patients Undergoing Cardiac Surgery
A study testing Pre-incisional Ultrasound guided (PIFP) block and Post-incisional Surgeon delivered parasternal block group in people with Pectointercostal Fascial Plane Block, run by Assiut University.
Trial summary
The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block in children undergoing congenital heart surgery is associated with differences in outcomes when compared to ultrasound-guided pre-incisional parasternal block in the form of Pectointercostal fascial plane… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pectointercostal Fascial Plane Block
- What is being tested?
- Pre-incisional Ultrasound guided (PIFP) block and Post-incisional Surgeon delivered parasternal block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Nov 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acyanotic Congenital heart disease; ASD (atrial septal defect), VSD (ventricular septal defect), and CAVC (common atrioventricular canal).
- Elective open-heart surgery via median sternotomy and under CPB (cardiopulmonary bypass).
- Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation.
Who cannot join
- Previous, urgent, or emergent cardiac surgery. Children with cyanotic congenital heart disease. local infection of the skin at the site of needle puncture, Allergy to bupivacaine, Coagulation disorders, Clinically significant liver or kidney disease, Heart failure or severe pulmonary hypertension.
Trial locations and contacts
No sites are listed yet.
Alaa Attia, MD contact
About this study
Official title: Optimal Timing of Parasternal Intercostal Nerve Block in Pediatric Patients Undergoing Cardiac Surgery
The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block in children undergoing congenital heart surgery is associated with differences in outcomes when compared to ultrasound-guided pre-incisional parasternal block in the form of Pectointercostal fascial plane block (PIFB).
Read the detailed description
Although many studies have found that pre-incisional parasternal block is effective in preventing postoperative sternotomy pain, we found no randomized controlled trials comparing pre-incisional vs post-incisional parasternal block in pediatric patients except for one retrospective cohort study done by Lisa et al comparing surgeon-delivered local anesthetic wound infiltration vs postoperative bilateral Petco-Intercostal Fascial Blocks. The post-incisional parasternal block may give prolonged postoperative pain control (equivalent to analgesia duration of pre-incisional parasternal block plus the duration of the operative procedure.)
- Conditions
- Pectointercostal Fascial Plane Block
- Being tested
- Pre-incisional Ultrasound guided (PIFP) block, Post-incisional Surgeon delivered parasternal block group
- Keywords
- pectointercostal fascial plane block, pediatrics, open cardiac surgery, optimal timing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-incisional Ultrasound guided (PIFP) blockProcedure or surgery
Also called Pectointercostal fascial plane block
Patients in group P will be injected with 0.4 mL/kg of 0.25 bupivacaine in the fascial plane between the internal intercostal and pectoralis major muscles on each side of the sternum after induction of anesthesia and before skin incision under ultrasound guidance.
Post-incisional Surgeon delivered parasternal block groupProcedure or surgery
After sternal closure, the surgeon will inject bupivacaine (0.5- to 2-mL aliquots depending on the weight) in the fascial plane under direct vision between the 5 anterior (2nd-6th) intercostal spaces on each side 1 to 1.5 cm lateral to the sternal edge using 25-gauge, 50 mm needle. The surgeon will inject the same dose and concentration of bupivacaine used in the ultrasound technique. This technique was prescribed before by Chaudhary et al (23).
In both techniques, the maximum dose of bupivacaine will never be exceeded (2 mg/kg). In addition, all patients were administered 2 mL of 0.25% bupivacaine at the site of the mediastinal drain location.
| Study group | Role | What they receive |
|---|---|---|
| Pre-incisional PIFB | Active comparator | Group P (ultrasound guided parasternal; PIFP block): patients will be injected with 0.4 mL/kg 0.25 bupivacaine in the fascial plane between the pectoralis major and internal intercostal muscles on each side of the sternum after induction of anesthesia and before skin incision under ultrasound guidance. Receives: Procedure: Pre-incisional Ultrasound guided (PIFP) block |
| Post-incisional PIFB | Active comparator | Group S: After sternal closure, the surgeon will inject bupivacaine (0.5- to 2-mL aliquots depending on the weight) in the fascial plane under direct vision between the 5 anterior (2nd-6th) intercostal spaces on each side 1 to 1.5 cm lateral to the sternal edge using 25-gauge, 50 mm needle. The surgeon will inject the same dose and concentration of bupivacaine used in the ultrasound technique. This technique was prescribed before by Chaudhary et al (23).
In both techniques, the maximum dose of bupivacaine will never be exceeded (2 mg/kg). In addition, all patients were administered 2 mL of 0.25% bupivacaine at the site of the mediastinal drain location. Receives: Procedure: Post-incisional Surgeon delivered parasternal block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesia request.
The first analgesic request after extubation
Measured: 24 hours
Amount of rescue analgesia.
Amount of rescue analgesia (total dose of fentanyl) after extubation.
Measured: 24 hours
Secondary outcomes (2)
Postoperative pain score:
Postoperative pain will be assessed by modified objective pain score (MOPS) in children at 0, 2, 6, 12, 16, 20, and 24 h after extubation. Wilson and Doyle modified the objective pain score by replacing blood pressure with posture. MOPS consists of 5 items (crying, movements, agitations, posture, and verbal). The minimum score is 0 (No pain) and the maximum is 10 (most sever pain).
Measured: at extubation, 2nd, 6th, 12th, 16th, 20th, and 24th hour after extubation.
Intraoperative fentanyl consumption
Measured: time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionNov 2023 (estimated)
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 Pectointercostal Fascial Plane BlockStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Ali Ahmed, Assiut University
- Investigators
- Mohamed Ahmed Ali Ahmed, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539885
- Sponsor's protocol ID
- Parasternal block
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pollak U, Serraf A. Pediatric Cardiac Surgery and Pain Management: After 40 Years in the Desert, Have We Reached the Promised Land? World J Pediatr Congenit Heart Surg. 2018 May;9(3):315-325. doi: 10.1177/2150135118755977.
PubMed 29692232Roy N, Parra MF, Brown ML, Sleeper LA, Nathan M, Sefton BA, Baird CW, Mistry KP, Del Nido PJ. Initial experience introducing an enhanced recovery program in congenital cardiac surgery. J Thorac Cardiovasc Surg. 2020 Nov;160(5):1313-1321.e5. doi: 10.1016/j.jtcvs.2019.10.049. Epub 2019 Oct 24.
PubMed 31859070Zhang Y, Chen S, Gong H, Zhan B. Efficacy of Bilateral Transversus Thoracis Muscle Plane Block in Pediatric Patients Undergoing Open Cardiac Surgery. J Cardiothorac Vasc Anesth. 2020 Sep;34(9):2430-2434. doi: 10.1053/j.jvca.2020.02.005. Epub 2020 Feb 11.
PubMed 32151511
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Parasternal Intercostal Nerve Block in Pediatric Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05539885
- Acronym / sponsor ID
- Parasternal block
- Conditions
- Pectointercostal Fascial Plane Block
- Keywords
- pectointercostal fascial plane block, pediatrics, open cardiac surgery, optimal timing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 14 Sep 2022 (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 objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block in children undergoing congenital heart surgery is associated with differences in outcomes when compared to ultrasound-guided pre-incisional parasternal block in the form of Pectointercostal fascial plane block (PIFB).
Detailed description
Although many studies have found that pre-incisional parasternal block is effective in preventing postoperative sternotomy pain, we found no randomized controlled trials comparing pre-incisional vs post-incisional parasternal block in pediatric patients except for one retrospective cohort study done by Lisa et al comparing surgeon-delivered local anesthetic wound infiltration vs postoperative bilateral Petco-Intercostal Fascial Blocks. The post-incisional parasternal block may give prolonged postoperative pain control (equivalent to analgesia duration of pre-incisional parasternal block plus the duration of the operative procedure.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-incisional PIFB | Active comparator | Procedure: Pre-incisional Ultrasound guided (PIFP) blockGroup P (ultrasound guided parasternal; PIFP block): patients will be injected with 0.4 mL/kg 0.25 bupivacaine in the fascial plane between the pectoralis major and internal intercostal muscles on each side of the sternum after induction of anesthesia and before skin incision under ultrasound guidance. |
| Post-incisional PIFB | Active comparator | Procedure: Post-incisional Surgeon delivered parasternal block groupGroup S: After sternal closure, the surgeon will inject bupivacaine (0.5- to 2-mL aliquots depending on the weight) in the fascial plane under direct vision between the 5 anterior (2nd-6th) intercostal spaces on each side 1 to 1.5 cm lateral to the sternal edge using 25-gauge, 50 mm needle. The surgeon will inject the same dose and concentration of bupivacaine used in the ultrasound technique. This technique was prescribed before by Chaudhary et al (23). In both techniques, the maximum dose of bupivacaine will never be exceeded (2 mg/kg). In addition, all patients were administered 2 mL of 0.25% bupivacaine at the site of the mediastinal drain location. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Acyanotic Congenital heart disease; ASD (atrial septal defect), VSD (ventricular septal defect), and CAVC (common atrioventricular canal).
- Elective open-heart surgery via median sternotomy and under CPB (cardiopulmonary bypass).
- Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation.
Key exclusion criteria (1 listed)
- Previous, urgent, or emergent cardiac surgery. Children with cyanotic congenital heart disease. local infection of the skin at the site of needle puncture, Allergy to bupivacaine, Coagulation disorders, Clinically significant liver or kidney disease, Heart failure or severe pulmonary hypertension.
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 |
|---|---|---|
| Pre-incisional Ultrasound guided (PIFP) blockAlso: Pectointercostal fascial plane blockPatients in group P will be injected with 0.4 mL/kg of 0.25 bupivacaine in the fascial plane between the internal intercostal and pectoralis major muscles on each side of the sternum after induction of anesthesia and before skin incision under ultrasound guidance. | Procedure or surgery | Pre-incisional PIFB |
| Post-incisional Surgeon delivered parasternal block groupAfter sternal closure, the surgeon will inject bupivacaine (0.5- to 2-mL aliquots depending on the weight) in the fascial plane under direct vision between the 5 anterior (2nd-6th) intercostal spaces on each side 1 to 1.5 cm lateral to the sternal edge using 25-gauge, 50 mm needle. The surgeon will inject the same dose and concentration of bupivacaine used in the ultrasound technique. This technique was prescribed before by Chaudhary et al (23). In both techniques, the maximum dose of bupivacaine will never be exceeded (2 mg/kg). In addition, all patients were administered 2 mL of 0.25% bupivacaine at the site of the mediastinal drain location. | Procedure or surgery | Post-incisional PIFB |
Primary outcome
Time to first analgesia request.
Time frame: 24 hours
The first analgesic request after extubation
Amount of rescue analgesia.
Time frame: 24 hours
Amount of rescue analgesia (total dose of fentanyl) after extubation.
2 secondary outcomes
Postoperative pain score:
Time frame: at extubation, 2nd, 6th, 12th, 16th, 20th, and 24th hour after extubation.
Intraoperative fentanyl consumption
Time frame: time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Background: PubMed 29692232Pollak U, Serraf A. Pediatric Cardiac Surgery and Pain Management: After 40 Years in the Desert, Have We Reached the Promised Land? World J Pediatr Congenit Heart Surg. 2018 May;9(3):315-325. doi: 10.1177/2150135118755977.
- Background: PubMed 31859070Roy N, Parra MF, Brown ML, Sleeper LA, Nathan M, Sefton BA, Baird CW, Mistry KP, Del Nido PJ. Initial experience introducing an enhanced recovery program in congenital cardiac surgery. J Thorac Cardiovasc Surg. 2020 Nov;160(5):1313-1321.e5. doi: 10.1016/j.jtcvs.2019.10.049. Epub 2019 Oct 24.
- Background: PubMed 32151511Zhang Y, Chen S, Gong H, Zhan B. Efficacy of Bilateral Transversus Thoracis Muscle Plane Block in Pediatric Patients Undergoing Open Cardiac Surgery. J Cardiothorac Vasc Anesth. 2020 Sep;34(9):2430-2434. doi: 10.1053/j.jvca.2020.02.005. Epub 2020 Feb 11.
- 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.
Alaa Attia, MD contact
Mohamed Ahmed Ali Ahmed, MD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Pre-incisional Ultrasound guided (PIFP) block and Post-incisional Surgeon delivered parasternal block group in people with Pectointercostal Fascial Plane Block, run by Assiut University.
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 1 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 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohamed Ahmed Ali Ahmed, MD (+201008707460, drmoali@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first analgesia request. (time frame: 24 hours). 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 NCT05539885, 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 19 Sep 2022.