Parasternal Intercostal Nerve BlockNCT05518266
Sonar Guided vs Surgeon Delivered Parasternal Block
A study testing US-guided Parasternal block and Surgeon-delivered parasternal block in people with Parasternal Intercostal Nerve 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 is at least non-inferior in relieving postoperative pain in adult patients scheduled for cardiac surgery involving sternotomy compared with ultrasound-guided post-incisional PIFB. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parasternal Intercostal Nerve Block
- What is being tested?
- US-guided Parasternal block and Surgeon-delivered parasternal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: from 18 to 75 years.
- Rheumatic heart disease needing elective valve replacement (mitral, aortic, or double valve replacement) 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.
- Patients undergoing coronary artery bypass grafting (CABG)
- 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.
- severe renal, pulmonary, liver, or endocrine systemic disease,
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound-guided Versus Surgeon Delivered Post-incisional Parasternal Block in Adult Patients Undergoing Open Cardiac Surgery: Are They the Same?
The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block is at least non-inferior in relieving postoperative pain in adult patients scheduled for cardiac surgery involving sternotomy compared with ultrasound-guided post-incisional PIFB.
Read the detailed description
Patients will be randomly allocated (using a sequence of computer-generated random numbers) into one of two groups (44 patients in each); group P (ultrasound guided parasternal; PIFP block) and group S (surgeon delivered parasternal block).
- group P (ultrasound guided parasternal; PIFP block): Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance
- Group S (surgeon delivered parasternal block). Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.
- Conditions
- Parasternal Intercostal Nerve Block
- Being tested
- US-guided Parasternal block, Surgeon-delivered parasternal block
- Keywords
- pectointercostal fascial plane block, parasternal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided Parasternal blockProcedure or surgery
Also called Pectointercostal fascial plane block
Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance
Surgeon-delivered parasternal blockProcedure or surgery
Just before wiring of the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.
| Study group | Role | What they receive |
|---|---|---|
| US-guided post-incisional PIFB | Active comparator | Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of the sternum after skin closure under ultrasound guidance Receives: Procedure: US-guided Parasternal block |
| Surgeon-delivered post-incisional parasternal block | Active comparator | Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision. Receives: Procedure: Surgeon-delivered parasternal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative pain score
Postoperative pain score will be measured after extubation at 0, 3, 6, 12, 16, 20, and 24 hours, using a visual analog scale (VAS). We are interested in the time at which postoperative pain is most severe.
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme.
A score of 0 is "no pain and a score of 10 is "worst imaginable pain"
Measured: 24 hours
Secondary outcomes (1)
Amount of rescue analgesia
Amount of rescue analgesia (total dose of fentanyl) during the first 24 hours after extubation.
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 posted26 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 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 Parasternal Intercostal Nerve 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
- 88 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518266
- Sponsor's protocol ID
- PIFPB Adults
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
PubMed 31054241Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.
PubMed 25796483Vilite B, Strike E, Rutka K, Leibuss R. Pain management in intensive care unit patients after cardiac surgery with sternotomy approach. Acta Med Litu. 2019;26(1):51-63. doi: 10.6001/actamedica.v26i1.3956.
PubMed 31281217
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Versus Surgeon Delivered Post-incisional Parasternal Block in Adult Patients Undergoing Open Cardiac Surgery: Are They the Same?
- ClinicalTrials.gov ID
- NCT05518266
- Acronym / sponsor ID
- PIFPB Adults
- Conditions
- Parasternal Intercostal Nerve Block
- Keywords
- pectointercostal fascial plane block, parasternal block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Aug 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 is at least non-inferior in relieving postoperative pain in adult patients scheduled for cardiac surgery involving sternotomy compared with ultrasound-guided post-incisional PIFB.
Detailed description
Patients will be randomly allocated (using a sequence of computer-generated random numbers) into one of two groups (44 patients in each); group P (ultrasound guided parasternal; PIFP block) and group S (surgeon delivered parasternal block).
- group P (ultrasound guided parasternal; PIFP block): Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance
- Group S (surgeon delivered parasternal block). Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided post-incisional PIFB | Active comparator | Procedure: US-guided Parasternal blockBupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of the sternum after skin closure under ultrasound guidance |
| Surgeon-delivered post-incisional parasternal block | Active comparator | Procedure: Surgeon-delivered parasternal blockJust before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: from 18 to 75 years.
- Rheumatic heart disease needing elective valve replacement (mitral, aortic, or double valve replacement) 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 (8 listed)
- • Previous, urgent, or emergent cardiac surgery.
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 |
|---|---|---|
| US-guided Parasternal blockAlso: Pectointercostal fascial plane blockBupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance | Procedure or surgery | US-guided post-incisional PIFB |
| Surgeon-delivered parasternal blockJust before wiring of the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision. | Procedure or surgery | Surgeon-delivered post-incisional parasternal block |
Primary outcome
Change in postoperative pain score
Time frame: 24 hours
Postoperative pain score will be measured after extubation at 0, 3, 6, 12, 16, 20, and 24 hours, using a visual analog scale (VAS). We are interested in the time at which postoperative pain is most severe. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. A score of 0 is "no pain and a score of 10 is "worst imaginable pain"
1 secondary outcome
Amount of rescue analgesia
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 15 Sep 2022.
- Results publication: PubMed 31054241Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
- Results publication: PubMed 25796483Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.
- Results publication: PubMed 31281217Vilite B, Strike E, Rutka K, Leibuss R. Pain management in intensive care unit patients after cardiac surgery with sternotomy approach. Acta Med Litu. 2019;26(1):51-63. doi: 10.6001/actamedica.v26i1.3956.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided Parasternal block and Surgeon-delivered parasternal block in people with Parasternal Intercostal Nerve 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 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: status not confirmed, as of the sponsor's last update on 15 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 (+201008707460, drmoali@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative pain score (time frame: 24 hours). 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 NCT05518266, 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 15 Sep 2022.