Pain, AcuteNCT05363540
Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery
A study testing pre-incisional parasternal intercostal block and post-incisional parasternal intercostal block in people with Pain, Acute, run by Benha University at 1 site in Egypt.
Trial summary
Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions, and the inability to cough due to median sternotomy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- pre-incisional parasternal intercostal block and post-incisional parasternal intercostal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Mar 2022to 24 Dec 2022
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 20-70 years,
- Scheduled to undergo elective cardiac surgeries through median sternotomy involving cardiopulmonary bypass (CPB).
Who cannot join
- Patients requiring preoperative inotropes, mechanical ventilation or intra-aortic balloon pump,
- patients who have previous cardiac surgery,
- prolonged CPB time (CPB>120 minutes),
- Intubation time more than 12hrs or planned for overnight ventilation.
- Allergy to any of used drugs,
- opioids addiction,
- Chronic liver disease, chronic renal disease, and cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Timing of Parasternal Intercostal Nerve Block Application (Pre-incisional Versus Post-incisional) for Acute Pain Management in Cardiac Surgery; a Randomized Double Blinded Clinical Trial
Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions, and the inability to cough due to median sternotomy. Therefore, duration of mechanical ventilation, length of intensive care unit (ICU) stay, and length of hospital stay of these patients will increase significantly.
many facial plane blocks have been introduced as simple and safe intervention for thoracic wall anesthesia and analgesia. Parasternal intercostal nerve block (PSIB) is a "superficial block" which involves local anesthetic (LA) infiltration in the intercostal space around the sternum where the anterior branches of intercostal nerves exist.
Intraoperative LA administration under direct vision of the surgeon ensures adequate delivery of drugs and minimizes bleeding complication or inadvertent administration in blood vessels. Meanwhile, Preoperative administration of LA guided by ultrasound imaging has been used in variable surgical settings with noticeable success because of preemptive inhibition of noxious stimuli.
- Conditions
- Pain, Acute
- Being tested
- pre-incisional parasternal intercostal block, post-incisional parasternal intercostal block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-incisional parasternal intercostal blockProcedure or surgery
LA will be administrated by the anesthesiologist under ultrasound guidance and before surgical incision On either side of thorax, 2 cm lateral to sternal edge from 2nd to 6th intercostal space, A volume of (4 mL) of 0.25% bupivacaine will be used
post-incisional parasternal intercostal blockProcedure or surgery
LA will be administered by the cardiac surgeon before the sternal closure. injection will introduced 2 cm lateral to sternal edge from 2nd to 6th intercostal space and volume (4 mL) of 0.25% bupivacaine will be used.
| Study group | Role | What they receive |
|---|---|---|
| Pre-incisional parasternal block | Active comparator | ultrasound guided parasternal intercostal block will be administrated before surgical incision. Receives: Procedure: pre-incisional parasternal intercostal block |
| Post-incisional parasternal block | Active comparator | under direct vision parasternal intercostal block will be administrated after surgical incision and before closure of the sternum. Receives: Procedure: post-incisional parasternal intercostal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of rescue analgesia
Total amount of opioid administered as rescue analgesia postoperative.
Measured: 24 hours postoperative
Secondary outcomes (6)
Intraoperative total fentanyl requirements
the amount of consumed opioid during the procedure
Measured: during surgery
intraoperative mean arterial blood pressure (MAP)
hemodynamic variability due to surgical stimulation
Measured: during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)
pain score (VAS)
VAS scores will be recorded by making a handwritten mark on a 10-cm line that represented a continuum between "no pain" and "worst possible pain."
Measured: at extubation, 12th, 16th, 20th, and 24th hour postoperative
adverse effects
nausea, vomiting, excessive sedation, respiratory depression
Measured: 24 hours postoperative
patient satisfaction
0 "extremely unsatisfied" to 10 "extremely satisfied"
Measured: 28 hours postoperative
Intensive Care Unit (ICU) Length of Stay
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start22 Mar 2022
- Primary completion20 Nov 2022
- Study completion24 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Benha 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363540
- Sponsor's protocol ID
- RC.1-3-2022
- Status last verified
- Jun 2023
- First submitted
- 17 Apr 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Parasternal Intercostal Nerve Block Application (Pre-incisional Versus Post-incisional) for Acute Pain Management in Cardiac Surgery; a Randomized Double Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05363540
- Acronym / sponsor ID
- RC.1-3-2022
- Conditions
- Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 24 Dec 2022 (actual)
- First posted
- 6 May 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.
Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions, and the inability to cough due to median sternotomy. Therefore, duration of mechanical ventilation, length of intensive care unit (ICU) stay, and length of hospital stay of these patients will increase significantly.
many facial plane blocks have been introduced as simple and safe intervention for thoracic wall anesthesia and analgesia. Parasternal intercostal nerve block (PSIB) is a "superficial block" which involves local anesthetic (LA) infiltration in the intercostal space around the sternum where the anterior branches of intercostal nerves exist.
Intraoperative LA administration under direct vision of the surgeon ensures adequate delivery of drugs and minimizes bleeding complication or inadvertent administration in blood vessels. Meanwhile, Preoperative administration of LA guided by ultrasound imaging has been used in variable surgical settings with noticeable success because of preemptive inhibition of noxious stimuli.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-incisional parasternal block | Active comparator | Procedure: pre-incisional parasternal intercostal blockultrasound guided parasternal intercostal block will be administrated before surgical incision. |
| Post-incisional parasternal block | Active comparator | Procedure: post-incisional parasternal intercostal blockunder direct vision parasternal intercostal block will be administrated after surgical incision and before closure of the sternum. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age from 20-70 years,
- Scheduled to undergo elective cardiac surgeries through median sternotomy involving cardiopulmonary bypass (CPB).
Key exclusion criteria (7 listed)
- Patients requiring preoperative inotropes, mechanical ventilation or intra-aortic balloon pump,
- patients who have previous cardiac surgery,
- prolonged CPB time (CPB>120 minutes),
- Intubation time more than 12hrs or planned for overnight ventilation.
- Allergy to any of used 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 |
|---|---|---|
| pre-incisional parasternal intercostal blockLA will be administrated by the anesthesiologist under ultrasound guidance and before surgical incision On either side of thorax, 2 cm lateral to sternal edge from 2nd to 6th intercostal space, A volume of (4 mL) of 0.25% bupivacaine will be used | Procedure or surgery | Pre-incisional parasternal block |
| post-incisional parasternal intercostal blockLA will be administered by the cardiac surgeon before the sternal closure. injection will introduced 2 cm lateral to sternal edge from 2nd to 6th intercostal space and volume (4 mL) of 0.25% bupivacaine will be used. | Procedure or surgery | Post-incisional parasternal block |
Primary outcome
Amount of rescue analgesia
Time frame: 24 hours postoperative
Total amount of opioid administered as rescue analgesia postoperative.
6 secondary outcomes
Intraoperative total fentanyl requirements
Time frame: during surgery
intraoperative mean arterial blood pressure (MAP)
Time frame: during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)
pain score (VAS)
Time frame: at extubation, 12th, 16th, 20th, and 24th hour postoperative
adverse effects
Time frame: 24 hours postoperative
patient satisfaction
Time frame: 28 hours postoperative
Intensive Care Unit (ICU) Length of Stay
Time frame: up to 6 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 22 Jun 2023.
- 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.
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 study testing pre-incisional parasternal intercostal block and post-incisional parasternal intercostal block in people with Pain, Acute, run by Benha 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 7 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 22 Jun 2023. 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?
Amount of rescue analgesia (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2023.