Transversus Thoracis Plane Block Versus Parasternal Intercostal Nerve Plane Block for Cardiac Surgery

NCT06155097 | Unknown

• 1 other identifier: 14-11-2023
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Traditionally postoperative pain management after cardiac surgery has been based on opiate analgesics. However, opiates have some undesirable dose-related side-effects such as nausea, constipation, vomiting, dizziness, mental confusion and respiratory depression, which substantially influence patient recovery and may delay discharge after surgery. The American Society of Anesthesiologists has endorsed multi- modal analgesia, involving multiple analgesics with differing modes of action, to reduce the overreliance on opioid-based postsurgical analgesic regimens and the associated adverse effects. The safety of using the transversus thoracis muscle plane block (TTP) or the parasternal intercostal nerve block (PSI block) for cardiac surgeries allow to make the option of using opioids alone and the possibility of its complications not the rule in post-operative pain relief in cardiac surgeries. In the current study, improving the quality of the transversus thoracis muscle plane block (TTP) or the parasternal intercostal nerve block (PSI block) for cardiothoracic surgeries by enhancing post-operative pain relief becomes more and more required to cope up with the new surgical modalities.

Conditions

Cardiac Surgery

Keywords

postcardiac surgery; transversus thoracis muscle plane block; parasternal intercostal nerve block; Enhanced recovery after surgery

Outcome Measures

Primary Outcomes (2)

• change in assessment of postoperative pain will be assessed by visual analogue scale (VAS) scale

  scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.

  at 1, 2, 3, 4, 8, 12, 16, 20 and 24 hours postoperatively

• The first requirement for analgesia:

  The time from injection of LA to patient first request of analgesia

  within 24 hour postoperative

Secondary Outcomes (3)

• Total amount of morphine consumed

  within 24 hour postoperative

• Extubation time

  within 24 hour postoperative

• ICU stay

  within 24 hour postoperative

Study Arms (3)

Control Group

NO INTERVENTION

Patients will not receive any regional injections

The transversus thoracis muscle plane block (TTP) group

ACTIVE COMPARATOR

Patients will receive the TTP block with administration of 20 ml volume of local anesthetics (Lidocaine 2% + Bupivicaine 0.5% 1:1 mixture + 8mg dexamethasone) bilaterally

Drug: transversus thoracis muscle plane block (TTP)

The parasternal intercostal nerve block (PSI block) group

ACTIVE COMPARATOR

Patients will receive the PSI block with administration of 20 ml volume of local anesthetics (Lidocaine 2% + Bupivicaine 0.5% 1:1 mixture + 8mg dexamethasone) bilaterally

Drug: parasternal intercostal nerve block (PSI block)

Interventions

transversus thoracis muscle plane block (TTP) DRUG

patient in supine position with chest exposed and monitored by beat-to-beat arterial tracing and standard monitors. After determining the anterior T4-T5 interspace using US, the US probe places in the longitudinal plane 1 cm lateral to the sternal border. A parasternal sagittal view of the internal intercostal muscle and the transversus thoracis muscle between the fourth and fifth rib will be visualized above the pleura. A 22-gage needle will be inserted in plane to the transducer with the tip of the needle located in the TTP between the internal intercostal and transversus thoracis muscles. After excluding intravascular and intrapleural placement, LA will administer with intermittent aspiration (administration of 20 ml volume of local anesthetics (Lidocaine 2% +Bupivicaine 0.5% 1:1 mixture + 8mg dexamethasone) on each side. After block administration, the patients will be monitored for LA toxicity, hemodynamic instability, and allergic or unexpected adverse reactions for 20 minutes.

The transversus thoracis muscle plane block (TTP) group

parasternal intercostal nerve block (PSI block) DRUG

patient in supine position with chest exposed and monitored by beat-to-beat arterial tracing and standard. Ultrasound scan will be performed from lateral to medial in the intercostal space. The intercostal muscles and pleura will be identified along the lower border of the rib. At the lateral border of the sternum, internal thoracic vessels lying anterior to transverse thoracic muscle are identified. The needle will be inserted in-plane to follow its tip using 4-mL injections per intercostal space across levels two through six bilaterally, for a total of 40 mL (Lidocaine 2% +Bupivicaine 0.5% 1:1 mixture + 8mg dexamethasone)

The parasternal intercostal nerve block (PSI block) group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance.
• Sex: both; male and female
• Age (21-60) years old.
• American society of anesthesiology (ASA): II and III.
• Body mass index (BMI) \>35 kg/m2
• Elective cardiac surgeries requiring median sternotomy.
• Accepted mental state of the patient.
• Non-smoker or ex-smoker for more than one month.
• Optimal preoperative glycemic control, defined by a hemoglobin A1c level less than 6.5%.

You may not qualify if:

• Patient refusal and lack of informed consent.
• Emergency or non-median sternotomy surgery.
• History of allergy to local anesthetics (lidocaine or bupivicaine).
• Coexisting hematologic disorders or malnourished patient.
• Pre-existing major organ dysfunction including hepatic or renal failure, and left ventricular ejection fraction \<30%
• Peripheral neuropathy.
• Pregnancy.
• Patients with a diagnosis of cognitive impairment.
• Significant psychiatric illnesses including schizophrenia, bipolar disorder, uncontrolled anxiety, or depression.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

faculty of medicine, Zagazig university

Zagazig, Elsharqya, 44519, Egypt

RECRUITING

Related Publications (5)

• Fleming IO, Garratt C, Guha R, Desai J, Chaubey S, Wang Y, Leonard S, Kunst G. Aggregation of Marginal Gains in Cardiac Surgery: Feasibility of a Perioperative Care Bundle for Enhanced Recovery in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):665-70. doi: 10.1053/j.jvca.2016.01.017. Epub 2016 Jan 16.

  PMID: 27321791 BACKGROUND

• Grant MC, Isada T, Ruzankin P, Whitman G, Lawton JS, Dodd-O J, Barodka V; Johns Hopkins Enhanced Recovery Program for the Cardiac Surgery Working Group. Results from an enhanced recovery program for cardiac surgery. J Thorac Cardiovasc Surg. 2020 Apr;159(4):1393-1402.e7. doi: 10.1016/j.jtcvs.2019.05.035. Epub 2019 Jun 7.

  PMID: 31279510 BACKGROUND

• Li M, Zhang J, Gan TJ, Qin G, Wang L, Zhu M, Zhang Z, Pan Y, Ye Z, Zhang F, Chen X, Lin G, Huang L, Luo W, Guo Q, Wang E. Enhanced recovery after surgery pathway for patients undergoing cardiac surgery: a randomized clinical trial. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):491-497. doi: 10.1093/ejcts/ezy100.

  PMID: 29514224 BACKGROUND

• Ueshima H, Takeda Y, Ishikawa S, Otake H. RETRACTED: Ultrasound-guided transversus thoracic muscle plane block: a cadaveric study of the spread of injectate. J Clin Anesth. 2015 Dec;27(8):696. doi: 10.1016/j.jclinane.2015.05.013. Epub 2015 Jul 3. No abstract available.

  PMID: 26144912 BACKGROUND

• 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. Epub 2006 Dec 22.

  PMID: 17678782 BACKGROUND

Study Officials

• Howaida A Kamal, MD

  faculty of medicine, Zagazig university, Egypt

  STUDY DIRECTOR

Central Study Contacts

Rehab A Wahdan, MD

CONTACT

01003481323; obz13w@yahoo.com

Mohamed S Elbramawi

CONTACT

01004119009; dr_elbramawi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded (patient and outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care

Model Details: The patients will be divided into 3 groups by a computer-generated randomization table

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: December 15, 2023
• Primary Completion: April 15, 2024
• Study Completion: May 15, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator

Locations

EG (1)