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

Surgery Clinical Trial

— PARARECTUS  

Official title:

Ultrasound Guided Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764616
• Other study ID #: PAR 06.23
• Status: Completed
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: November 10, 2023

Study information

• Verified date: November 2023
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Cardiac Disease
• Heart Diseases
• Postoperative Pain
• Surgery

Intervention

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.
• 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
• RECTUS SHEATH BLOCK
At the end of surgery, a rectus sheath block will be performed with 10 mL of ropivacaine 0.25% per side.

Locations

Country	Name	City	State
Italy	Campus Bio-medico University Hospital Foundation	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Barr AM, Tutungi E, Almeida AA. Parasternal intercostal block with ropivacaine for pain management after cardiac surgery: a double-blind, randomized, controlled trial. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):547-53. doi: 10.1053/j.jvca.2006.09.003. Epu — View Citation

Bloc S, Perot BP, Gibert H, Law Koune JD, Burg Y, Leclerc D, Vuitton AS, De La Jonquiere C, Luka M, Waldmann T, Vistarini N, Aubert S, Menager MM, Merzoug M, Naudin C, Squara P. Efficacy of parasternal block to decrease intraoperative opioid use in corona — View Citation

Cibelli M, Brodier EA, Smith FG. Pectoralis-Intercostal-Rectus Sheath (PIRS) Plane Block With Catheters. A New Technique to Provide Analgesia in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):846-847. doi: 10.1053/j.jvca.2019.09.014. Epub 201 — View Citation

Elbahrawy K, El-Deeb A. Rectus sheath block for postoperative analgesia in patients with mesenteric vascular occlusion undergoing laparotomy: A randomized single-blinded study. Anesth Essays Res. 2016 Sep-Dec;10(3):516-520. doi: 10.4103/0259-1162.179315. — View Citation

Everett L, Davis TA, Deshpande SP, Mondal S. Implementation of Bilateral Rectus Sheath Blocks in Conjunction With Transversus Thoracis Plane and Pectointercostal Fascial Blocks for Immediate Postoperative Analgesia After Cardiac Surgery. Cureus. 2022 Jul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static Pain Score	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	24 hours
Primary	Dynamic Pain Score	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	24 hours
Secondary	Intraoperative Fentanyl Consumption	Total intravenous fentanyl administration (expressed in milligrams) during surgery	4 hours
Secondary	Morphine Consumption	Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery	24 hours
Secondary	Time of Extubation	Interval between the end of surgery and patient's extubation	48 hours
Secondary	Respiratory performance at incentive spirometry	Respiratory performance is assessed preoperatively and postoperatively (at extubation) by the number of balls raised during inspiration with the TRI-FLOW spirometer	48 hours
Secondary	Intensive Care Unit (ICU) Discharge Time	Interval between patient arrival in ICU and discharge from ICU	120 hours
Secondary	Hospitalization Length of Stay	Total Hospital length of Stay (expressed in days)	30 days
Secondary	Incidence of adverse events	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.	24 hours