Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy
- Conditions
- AnalgesiaAcute PainCardiac DiseaseSurgeryPostoperative Pain
- Interventions
- Procedure: PARASTERNAL BLOCKProcedure: RECTUS SHEATH BLOCKProcedure: LOCAL INFILTRATION OF DRAINAGE EXIT SITES
- Registration Number
- NCT05764616
- Lead Sponsor
- Campus Bio-Medico University
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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
- Allergy to local anesthetics
- Puncture site infection
- Lack of signing of informed consent
- Age <18 years
- Emergency surgery
- ASA > IV
- preoperative acute respiratory failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RECTUS group RECTUS SHEATH BLOCK Patients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block CONTROL group LOCAL INFILTRATION OF DRAINAGE EXIT SITES Patients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic RECTUS group PARASTERNAL BLOCK Patients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block CONTROL group PARASTERNAL BLOCK Patients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time of Extubation 48 hours Interval between the end of surgery and patient's extubation
Intensive Care Unit (ICU) Discharge Time 120 hours Interval between patient arrival in ICU and discharge from ICU
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.Morphine Consumption 24 hours Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery
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
Trial Locations
- Locations (1)
Campus Bio-medico University Hospital Foundation
🇮🇹Rome, Italy