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Elective Cardiac SurgeryNCT06516432

Parasternal Blockade and Serum Lactate in Cardiac Surgery

A study testing Parasternal block and Requirement of total dose regarding fentanyl in people with Elective Cardiac Surgery, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Serum lactate level is a key indicator of tissue perfusion. Parasternal blockade is associated with reduced postoperative inflammatory response by inhibiting stress response, leading to better outcomes. Elevated lactate levels help identify 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
Elective Cardiac Surgery
What is being tested?
Parasternal block and Requirement of total dose regarding fentanyl
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 2024to 31 Dec 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients older than 18 years
  • Either sex
  • ASA II-III
  • Patients who underwent cardiac surgery with median sternotomy and use of cardiopulmonary bypass.

Who cannot join

  • Patients with pre-existing conditions that could independently affect serum lactate levels.

Trial locations and contacts

1 site in 1 country.

Alejandro Gonzalez, 3 contact

3331294165

avygail5@gmail.com

Clotilde Fuentes, 1 contact

3331154287

clotilde.fuentes@gmail.com

Mexico1 site, 1 recruiting

  • Centro Médico Nacional de Occidente

    Guadalajara, Jalisco, 44329

    Alejandro González Ojeda, PhD, 3336683000, avygail5@gmail.com

    Recruiting

Other trials in Mexico

About this study

Official title: Serum Lactate in the Application of Parasternal Blockade in Trans and Post Anesthetic Stages in Cardiac Surgery

Serum lactate level is a key indicator of tissue perfusion. Parasternal blockade is associated with reduced postoperative inflammatory response by inhibiting stress response, leading to better outcomes. Elevated lactate levels help identify patients at risk of postoperative morbidity and mortality. This analytical cross-sectional study evaluated the association between parasternal blockade and serum lactate levels in patients undergoing elective cardiac surgery in 2022 at Specialty Hospital CMNO. Patients with and without parasternal block were compared for changes in serum lactate levels during and after anesthesia within the first 24 hours.

Read the detailed description

Background: Serum lactate level is a crucial indicator of tissue perfusion. 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 the identification of patients at risk of postoperative morbidity and mortality.

Objective: To evaluate the association between parasternal blockade and serum lactate level in patients undergoing cardiac surgery, both trans and postanesthesia.

Materials and Methods: Analytical cross-sectional study in adult patients undergoing elective cardiac surgery during the year 2022 in Specialty Hospital CMNO, patients with and without application of parasternal block were analyzed, and it was associated with changes in serum lactate level trans and post anesthesia in the first 24 hours. Approval registration: R-2023-1301-024.

Being tested
Parasternal block, Requirement of total dose regarding fentanyl
Keywords
Parasternal block, Cardiac surgery, Serum lactate

What participants receive

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

  • Parasternal blockProcedure or surgery

    In the case-control groups, patients with elevated serum lactate levels above 2 mmol/L and those who remained below this limit will be identified.

  • Requirement of total dose regarding fentanylProcedure or surgery

    In case-control groups, obtain measurement of total postoperative fentanyl requirement.

Study groups in NCT06516432
Study groupRoleWhat they receive
Case groupExperimentalwith parasternal block
Receives: Procedure: Parasternal block; Procedure: Requirement of total dose regarding fentanyl
Control groupNo interventionwithout parasternal block

What is being measured

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

  1. Serum lactate measurement

    Elevated serum lactate levels above 2 mmol/L

    Measured: 24 hours postoperative

Timeline

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

  1. First posted24 Jul 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients will be classified into a case group with parasternal block and a control group without parasternal block, with a ratio of cases to controls of 1:1. In the case-control groups, patients with elevated serum lactate levels above 2 mmol/L and those who remained below this limit will be identified.
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516432
Sponsor's protocol ID
Parasternal Blockade 2024
Status last verified
Jul 2024
First submitted
10 Jul 2024
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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 coronary artery bypass surgery via sternotomy: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):671-678. doi: 10.1136/rapm-2020-102207. Epub 2021 May 14.

    PubMed 33990437

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Parasternal block and Requirement of total dose regarding fentanyl in people with Elective 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 4 inclusion and 1 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 24 Jul 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.

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 Alejandro Gonzalez, 3 (3331294165, avygail5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum lactate measurement (time frame: 24 hours postoperative). 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 NCT06516432, which also lists 15 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 Jul 2024.

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