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Cardiac SurgeryNCT06155097

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

A study testing transversus thoracis muscle plane block (TTP) and parasternal intercostal nerve block (PSI block) in people with Cardiac Surgery, run by Zagazig University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 60 years
Conditions the study is for
Cardiac Surgery
What is being tested?
transversus thoracis muscle plane block (TTP) and parasternal intercostal nerve block (PSI block)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteEgypt
Study dates
15 Dec 2023to 15 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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%.

Who cannot join

  • 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.
Show all 9Show fewer
  • Pregnancy.
  • Patients with a diagnosis of cognitive impairment.
  • Significant psychiatric illnesses including schizophrenia, bipolar disorder, uncontrolled anxiety, or depression.

Trial locations and contacts

1 site in 1 country.

Rehab A Wahdan, MD contact

01003481323 ext. 002

obz13w@yahoo.com

Egypt1 site, 1 recruiting
  • faculty of medicine, Zagazig university

    Zagazig, Elsharqya, 44519

    Howaida A Kamal, MD, 01225096755 ext. 002, k.howaida@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Role of Transversus Thoracis Plane Block Versus Parasternal Intercostal Nerve Plane Block in Enhanced Recovery Program After Cardiac Surgery: A Randomized Controlled Study

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.

Read more

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.

Read the detailed description

Enhanced Recovery After Surgery (ERAS) is an international effort to develop perioperative programs aimed at optimizing patient outcomes and healthcare delivery efficiency. These programs are composed of intervention bundles based on the principles of best practice, standardized and consistent healthcare delivery, regular audit, and team feedback, all with a patient-centered focus. Implementation of such programs has resulted in patient and healthcare benefits, including promising early results within the cardiac surgical community.

A perioperative, multimodal, opioid-sparing, pain management plan is classified as B-NR (B-level evidence, nonrandomized studies) in the classification of recommendation and level of evidence. The ERAS Cardiac Society's grading of this recommendation is appropriate because it is a laudable goal that requires additional research. Areas of investigation to refine postoperative pain management include the following: managing patient and provider expectations, individualizing the dose and types of analgesics, consideration of the potential cardioprotective effects of opioids, and incorporating nonpharmacologic approaches to pain management such as regional anesthesia.

Pain after cardiac surgery is caused by several factors; sternotomy, sternal/rib retraction, pericardiotomy, internal mammarian artery harvesting, saphenous vein harvesting, surgical manipulation of the parietal pleura, chest tube insertion and other musculoskeletal trauma during surgery.

Postoperative pain management remains an important clinical challenge in cardiothoracic surgery. Inadequate postoperative pain control may have adverse pathophysiologic sequelae, including increased myocardial oxygen demand, hypoventilation, suboptimal clearance of pulmonary secretions, acute respiratory failure, and decreased mobility, with associated increased risks for thromboembolic events. These adverse events may result in greater perioperative morbidity and mortality.

Despite several multimodal approaches to postoperative pain control, optimal pain management after cardiothoracic procedures remains elusive.

Regional anesthesia (RA) is often included in enhanced recovery protocols (ERPs) as an important component of a bundle of interventions to improve outcomes after surgery. Regional anesthesia techniques, including neuraxial and peripheral nerve block, can provide many benefits for patients in the perioperative period. These benefits include a decrease in postoperative pain (subsequently reducing opioid consumption and associated adverse effects), decrease in nausea and vomiting, improvement in mobilization and recovery of gastrointestinal function, decrease in length of stay (LOS), reduction in surgical stress response, and potentially, reduction in morbidity and mortality. They are therefore commonly used to improve quality of patient care and have also been used as a key component of many enhanced recovery protocols (ERPs).

The transversus thoracis muscle plane block (TTP) is a newly developed regional anesthesia technique which provides analgesia to the anterior chest wall. First described by Ueshima and Kitamura in 2015, the TTP block is a single-shot nerve block that deposits local anesthetic in the transversus thoracis muscle plane between the internal intercostal and transversus thoracis muscles. In the original ultrasound- guided cadaveric study, the TTP block was found to cover the T2-T6 intercostal nerves.

The anterior branches of these intercostal nerves dominate the sensory innervation of the internal mammary region, suggesting this new technique had potential to provide analgesia for surgery of the anterior chest wall.

Another technique for blocking multiple anterior branches of intercostal nerves, named the parasternal intercostal nerve block (PSI block). To perform a PSI block, we inject a local anesthetic between the pectoral major muscle and the external intercostal muscle. Because anterior branches of the intercostal nerve penetrate through these two muscles to innervate the internal mammary area, injection of a local anesthetic to this plane could block anterior branches of intercostal nerves.

Parasternal intercostal nerve blocks using local anesthetic agents have been shown to provide improved postoperative pain control and decreased opioid requirements with fewer potential complications.

This study can reduce economic cost by ENHANCED RECOVERY After Surgery (ERAS) (early extubation, reduce ICU and hospital stay) and improving postoperative analgesia. Implementation of such programs has resulted in patient and healthcare benefits, including promising early results within the cardiac surgical community.

Conditions
Cardiac Surgery
Being tested
transversus thoracis muscle plane block (TTP), parasternal intercostal nerve block (PSI block)
Keywords
postcardiac surgery, transversus thoracis muscle plane block, parasternal intercostal nerve block, Enhanced recovery after surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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)

Study groups in NCT06155097
Study groupRoleWhat they receive
Control GroupNo interventionPatients will not receive any regional injections
The transversus thoracis muscle plane block (TTP) groupActive comparatorPatients 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
Receives: Drug: transversus thoracis muscle plane block (TTP)
The parasternal intercostal nerve block (PSI block) groupActive comparatorPatients 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
Receives: Drug: parasternal intercostal nerve block (PSI block)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. The first requirement for analgesia:

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

    Measured: within 24 hour postoperative

Secondary outcomes (3)
  1. Total amount of morphine consumed

    Total amount of morphine given to each patient

    Measured: within 24 hour postoperative

  2. Extubation time

    Time from ICU admission to the time the endotracheal tube will be pulled out

    Measured: within 24 hour postoperative

  3. ICU stay

    Time from ICU admission to time of discharge to ward

    Measured: within 24 hour postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2023
  2. Study start15 Dec 2023
  3. Primary completion15 Apr 2024 (estimated)
  4. Study completion15 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients will be divided into 3 groups by a computer-generated randomization table
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06155097
Sponsor's protocol ID
14-11-2023
Status last verified
Jan 2024
First submitted
24 Nov 2023
Last updated
30 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: planned after the completion of the study and publication

Publications

  • 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.

    PubMed 27321791
  • 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.

    PubMed 31279510
  • 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.

    PubMed 29514224
  • 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.

    PubMed 26144912
  • 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.

    PubMed 17678782

Questions about this trial

What is this clinical trial studying?

A study testing transversus thoracis muscle plane block (TTP) and parasternal intercostal nerve block (PSI block) in people with Cardiac Surgery, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rehab A Wahdan, MD (01003481323 ext. 002, obz13w@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in assessment of postoperative pain will be assessed by visual analogue scale (VAS) scale (time frame: at 1, 2, 3, 4, 8, 12, 16, 20 and 24 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06155097, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

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