Acute Pain, Analgesia, Cardiac Disease, Postoperative Pain, Surgery
Conditions
Brief summary
The aim of this randomized controlled trial is to examine the effect of ultrasound guided bilateral Parasternal Nerve Block combined with rectus sheath block on preoperative analgesia, opioid consumption and respiratory function in patients undergoing cardiac surgery via sternotomy. Half of participants will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block while the other half receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic (without performing rectus sheath block)
Interventions
PROCEDUREPARASTERNAL BLOCK
After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side.
PROCEDURELOCAL INFILTRATION OF DRAINAGE EXIT SITES
At the end of surgery, a local infiltration of drainage exit sites will be performed with 10 mL of ropivacaine 0.25% per side
PROCEDURERECTUS SHEATH BLOCK
At the end of surgery, a rectus sheath block will be performed with 10 mL of ropivacaine 0.25% per side.
Sponsors
Campus Bio-Medico University
Study design
Allocation
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 under median sternotomy * Age \>= 18 years * American Society of Anesthesiologists (ASA) Status I-IV * Approval and sign of the informed consent
Exclusion criteria
* Allergy to local anesthetics * Puncture site infection * Lack of signing of informed consent * Age \<18 years * Emergency surgery * ASA \> IV * preoperative acute respiratory failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static Pain Score | 24 hours | A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery |
| Dynamic Pain Score | 24 hours | A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) during movement will be used to evaluate pain at rest during 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Extubation | 48 hours | Interval between the end of surgery and patient's extubation |
| Respiratory performance at incentive spirometry | 48 hours | Respiratory performance is assessed preoperatively and postoperatively (at extubation) by the number of balls raised during inspiration with the TRI-FLOW spirometer |
| Intraoperative Fentanyl Consumption | 4 hours | Total intravenous fentanyl administration (expressed in milligrams) during surgery |
| Hospitalization Length of Stay | 30 days | Total Hospital length of Stay (expressed in days) |
| Incidence of adverse events | 24 hours | Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity. Moreover, incidence of nausea, vomiting and postoperative respiratory complications will be recorded. |
| Intensive Care Unit (ICU) Discharge Time | 120 hours | Interval between patient arrival in ICU and discharge from ICU |
| Morphine Consumption | 24 hours | Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery |
Countries
Italy
Outcome results
None listed