PARARECTUS: Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy

• Sponsor: Campus Bio-Medico University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05764616
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease; Surgery; Analgesia; Acute Pain; Postoperative Pain	Procedure: PARASTERNAL BLOCK; Procedure: LOCAL INFILTRATION OF DRAINAGE EXIT SITES; Procedure: RECTUS SHEATH BLOCK	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ultrasound Guided Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy: A Randomized Controlled Trial
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RECTUS group Patients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block	Procedure: PARASTERNAL BLOCK; After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side.; Procedure: RECTUS SHEATH BLOCK; At the end of surgery, a rectus sheath block will be performed with 10 mL of ropivacaine 0.25% per side.
Active Comparator: CONTROL group Patients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic	Procedure: PARASTERNAL BLOCK; After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side.; Procedure: LOCAL 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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. Intraoperative Fentanyl Consumption [4 hours]

   Total intravenous fentanyl administration (expressed in milligrams) during surgery

2. Morphine Consumption [24 hours]

   Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery

3. Time of Extubation [48 hours]

   Interval between the end of surgery and patient's extubation

4. 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

5. Intensive Care Unit (ICU) Discharge Time [120 hours]

   Interval between patient arrival in ICU and discharge from ICU

6. Hospitalization Length of Stay [30 days]

   Total Hospital length of Stay (expressed in days)

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Campus Bio-medico University Hospital Foundation	Rome		Italy

Sponsors and Collaborators

• Campus Bio-Medico University

Investigators

• Principal Investigator: Giuseppe Pascarella, MD, University Hospital Campus Biomedico of Rome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giuseppe Pascarella, Principal Investigator, Campus Bio-Medico University
• ClinicalTrials.gov Identifier: NCT05764616
• Other Study ID Numbers: PAR 06.23
• First Posted: Mar 10, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases; Acute Pain

Study Results

No Results Posted as of Mar 10, 2023