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Parasternal Block for Cardiac Surgery

Parasternal Block for Postoperative Analgesia in Cardiac Surgery: a Pilot Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04319588
Acronym
Parasternal
Enrollment
126
Registered
2020-03-24
Start date
2020-03-06
Completion date
2020-05-19
Last updated
2023-02-08

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

Conditions

Acute Pain, Analgesia, Cardiac Disease, Postoperative Pain

Brief summary

This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.

Detailed description

60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups: 1. Interventional (parasternal group) 2. Case control group The parasternal group of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia. The case control group will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.

Interventions

PROCEDUREParasternal Block+ Infiltration with local anesthetic of access to thoracic drainage

After induction of general anesthesia we will perform an ultrasound-guided Parasternal Block in association with infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.

PROCEDUREInfiltration with local anesthetic of access to thoracic drainage

Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.

Sponsors

Campus Bio-Medico University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing elective cardiac surgery * Age over 18 years * ASA I-IV * Approval by the patient of informed consent

Exclusion criteria

* Allergy to local anesthetics * Puncture site infection * Lack of signing of informed consent * Weight \<30 Kg * Age \<18 years * Emergency interventions * ASA \> IV * Sternal dehiscences * Dementia (for difficulties in managing weaning from mechanical ventilation and pain)

Design outcomes

Primary

MeasureTime frameDescription
Maximum Pain Score24 hoursPostoperative pain assessment using the NRS scale (score from 0 to 10)

Secondary

MeasureTime frameDescription
Respiratory performance at the TRI-FLOW24 hoursRespiratory performance is assessed by the number of balls raised during inspiration with the TRI-FLOW
Intraoperative opioid administration4 hoursQuantitative evaluation of opioids needed in the intraoperative period
Total opioids consumption24 hoursNumber of opioid deliveries (bolus morphine) in the postoperative period
Time to first opioid48 hoursThe time in minutes between awakening and the first opioid administration

Countries

Italy

Outcome results

None listed

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