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Parasternal BlockPhase 3NCT06608290

Paraesternal Blockade and Lactate Serum Levels in Patients With Cardiac Surgery.

A Phase 3 study testing parasternal block and Lactate serum level in people with Parasternal Block and Cardiac Surgery, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Parasternal blockade has been related to a reduction of the postoperative inflammatory response, by inhibition of the stress response, leading to a better prognosis. Increased lactate level is a useful parameter in identifying patients at risk of postoperative morbidity and mortality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parasternal Block, Cardiac Surgery, Serum Lactate
What is being tested?
parasternal block and Lactate serum level
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteMexico
Study dates
1 Jan 2022to 2 Sep 2024
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients over 18 years of age
  • Either sex
  • ASA II-IV
  • Patients who underwent cardiac surgery with median sternotomy and use of cardiopulmonary bypass.
  • Elimination criteria
  • Patients with pre-existing conditions that could independently affect serum lactate levels

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, México

    Guadalajara, Jalisco, 44329

Other trials in Mexico

About this study

Official title: Association Between the Application of Parasternal Blockade and Serum Lactate Level in Trans and Post-anesthetic Stages in Cardiac Surgery.

Parasternal blockade has been related to a reduction of the postoperative inflammatory response, by inhibition of the stress response, leading to a better prognosis. Increased lactate level is a useful parameter in identifying patients at risk of postoperative morbidity and mortality. The objective was to evaluate the association between parasternal blockade and serum lactate level in patients undergoing cardiac surgery, both trans- and post-anesthesia. 86 patients between 60-70 years of age participated. An association was found between the application of parasternal blockade in cardiac surgery and the presence of lower trans and postanesthetic serum lactate levels.

Read the detailed description

An analytical cross-sectional study in adult patients who underwent elective cardiac surgery. A total sample of 86 patients was obtained, 43 in the case group and 43 in the control group. Adult patients older than 18 years, of either sex, with ASA II-III, patients who underwent cardiac surgery with median sternotomy and use of cardiopulmonary bypass were included.

Being tested
parasternal block, Lactate serum level
Keywords
Parasternal block, cardiac surgery, serum lactate, cardiopulmonary bypass, cardiovascular surgery post-surgical unit

What participants receive

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

  • parasternal blockProcedure or surgery

    Administration of parasternal block with ropivacaine, bilaterally at the sternum before the start of surgery.

  • Lactate serum levelDiagnostic test

    Blood samples were taken to identify serum lactate levels greater than 2 mmol/l and those that remained below this limit.

Study groups in NCT06608290
Study groupRoleWhat they receive
BlockadeExperimentalIn patients which parasternal block has been applied
Receives: Procedure: parasternal block; Diagnostic Test: Lactate serum level
ControlExperimentalIn patients which parasternal block has not been applied
Receives: Diagnostic Test: Lactate serum level

What is being measured

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

  1. Lactate serum levels

    Blood samples were taken to identify serum lactate levels greater than 2 mmol/l and those that remained below this limit.

    Measured: 24 Hours

Timeline

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

  1. First posted23 Sep 2024
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2022
  4. Study completion2 Sep 2024

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients were classified as a group of cases with parasternal blockade and as a group of controls without parasternal blockade, with a ratio of cases to controls of 1:1. In the case-control groups, patients with elevated serum lactate levels greater than 2 mmol/L and those who remained below this limit were identified.
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06608290
Sponsor's protocol ID
R-2023-1301-024.
Status last verified
Sep 2023
First submitted
19 Sep 2024
Last updated
24 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a closed study completed at a single center.

Publications

  • Zhou Y, Yang C, Jin Z, Zhang B. Intraoperative use of cell saver devices decreases the rate of hyperlactatemia in patients undergoing cardiac surgery. Heliyon. 2023 May 4;9(5):e15999. doi: 10.1016/j.heliyon.2023.e15999. eCollection 2023 May.

    PubMed 37215823

  • Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.

    PubMed 38148266

  • Chen Y, Li Q, Liao Y, Wang X, Zhan MY, Li YY, Liu GJ, Xiao L. Preemptive deep parasternal intercostal plane block for perioperative analgesia in coronary artery bypass grafting with sternotomy: a randomized, observer-blind, controlled study. Ann Med. 2023;55(2):2302983. doi: 10.1080/07853890.2024.2302983. Epub 2024 Feb 20.

    PubMed 38375661

  • Bhat HA, Khan T, Puri A, Narula J, Mir AH, Wani SQ, Ashraf HZ, Sidiq S, Kabir S. To evaluate the analgesic effectiveness of bilateral erector spinae plane block versus thoracic epidural analgesia in open cardiac surgeries approached through midline sternotomy. J Anesth Analg Crit Care. 2024 Mar 1;4(1):17. doi: 10.1186/s44158-024-00148-4.

    PubMed 38429852

  • Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.

    PubMed 31356362

  • Miao Q, Wu DJ, Chen X, Xu M, Sun L, Guo Z, He B, Wu J. Target blood pressure management during cardiopulmonary bypass improves lactate levels after cardiac surgery: a randomized controlled trial. BMC Anesthesiol. 2021 Dec 8;21(1):309. doi: 10.1186/s12871-021-01537-w.

    PubMed 34879822

  • Padala SRAN, Badhe AS, Parida S, Jha AK. Comparison of preincisional and postincisional parasternal intercostal block on postoperative pain in cardiac surgery. J Card Surg. 2020 Jul;35(7):1525-1530. doi: 10.1111/jocs.14651. Epub 2020 Jun 24.

    PubMed 32579779

  • Demir AZ, Ozgok A, Balci E, Karaca OG, Simsek E, Gunaydin S. Preoperative ultrasound-guided bilateral thoracic erector spinae plane block within an enhanced recovery program is associated with decreased intraoperative lactate levels in cardiac surgery. Perfusion. 2024 Mar;39(2):324-333. doi: 10.1177/02676591221140754. Epub 2022 Nov 21.

    PubMed 36408617

  • Liu H, Emelife PI, Prabhakar A, Moll V, Kendrick JB, Parr AT, Hyatali F, Pankaj T, Li J, Cornett EM, Urman RD, Fox CJ, Kaye AD. Regional anesthesia considerations for cardiac surgery. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):387-406. doi: 10.1016/j.bpa.2019.07.008. Epub 2019 Jul 17.

    PubMed 31791558

  • Seghrouchni A, Atmani N, Moutakiallah Y, Belmekki A, El Bekkali Y, Houssa MA. Does severe hyperlactatemia during cardiopulmonary bypass predict a worse outcome? Ann Med Surg (Lond). 2021 Dec 21;73:103198. doi: 10.1016/j.amsu.2021.103198. eCollection 2022 Jan.

    PubMed 35070281

  • Yang HH, Chang JC, Jhan JY, Cheng YT, Huang YT, Chang BS, Chao SF. Prognostic value of peak lactate during cardiopulmonary bypass in adult cardiac surgeries: A retrospective cohort study. Tzu Chi Med J. 2020 Feb 27;32(4):386-391. doi: 10.4103/tcmj.tcmj_215_19. eCollection 2020 Oct-Dec.

    PubMed 33163386

  • Wang D, Wang S, Wu J, Le S, Xie F, Li X, Wang H, Huang X, Du X, Zhang A. Nomogram Models to Predict Postoperative Hyperlactatemia in Patients Undergoing Elective Cardiac Surgery. Front Med (Lausanne). 2021 Dec 2;8:763931. doi: 10.3389/fmed.2021.763931. eCollection 2021.

    PubMed 34926506

  • Li JQ, Li ZH, Dong P, Liu P, Xu YZ, Fan ZJ. RETRACTED: Effects of parasternal intercostal block on surgical site wound infection and pain in patients undergoing cardiac surgery: A meta-analysis. Int Wound J. 2024 Feb;21(2):e14433. doi: 10.1111/iwj.14433. Epub 2023 Oct 17.

    PubMed 37846438

  • Schiavoni L, Nenna A, Cardetta F, Pascarella G, Costa F, Chello M, Agro FE, Mattei A. Parasternal Intercostal Nerve Blocks in Patients Undergoing Cardiac Surgery: Evidence Update and Technical Considerations. J Cardiothorac Vasc Anesth. 2022 Nov;36(11):4173-4182. doi: 10.1053/j.jvca.2022.07.025. Epub 2022 Jul 24.

    PubMed 35995636

  • Abadi A, Cohen R. Evaluation of an Enhanced Recovery After Surgery Protocol Including Parasternal Intercostal Nerve Block in Cardiac Surgery Requiring Sternotomy. Am Surg. 2021 Dec;87(10):1561-1564. doi: 10.1177/00031348211024638. Epub 2021 Jun 23.

    PubMed 34162242

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing parasternal block and Lactate serum level in people with Parasternal Block and Cardiac Surgery, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

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 6 inclusion and 0 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: finished, as of the sponsor's last update on 24 Sep 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 Mexico. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lactate serum levels (time frame: 24 Hours). 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 NCT06608290, which also lists 16 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 24 Sep 2024.

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