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Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05363540
Enrollment
51
Registered
2022-05-06
Start date
2022-03-22
Completion date
2022-12-24
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute

Brief 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. 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.

Interventions

PROCEDUREpre-incisional parasternal intercostal block

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

PROCEDUREpost-incisional parasternal intercostal block

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.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age from 20-70 years, * Scheduled to undergo elective cardiac surgeries through median sternotomy involving cardiopulmonary bypass (CPB).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Amount of rescue analgesia24 hours postoperativeTotal amount of opioid administered as rescue analgesia postoperative.

Secondary

MeasureTime frameDescription
intraoperative mean arterial blood pressure (MAP)during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)hemodynamic variability due to surgical stimulation
pain score (VAS)at extubation, 12th, 16th, 20th, and 24th hour postoperativeVAS 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.
Intraoperative total fentanyl requirementsduring surgerythe amount of consumed opioid during the procedure
patient satisfaction28 hours postoperative0 extremely unsatisfied to 10 extremely satisfied
Intensive Care Unit (ICU) Length of Stayup to 6 months
adverse effects24 hours postoperativenausea, vomiting, excessive sedation, respiratory depression

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026