Parasternal Blockade and Serum Lactate in Cardiac Surgery

NCT ID: NCT06516432

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Elective Cardiac Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Case group

with parasternal block

Group Type EXPERIMENTAL

Parasternal block

Intervention Type PROCEDURE

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 fentanyl

Intervention Type PROCEDURE

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

Control group

without parasternal block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Parasternal block

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.

Intervention Type PROCEDURE

Requirement of total dose regarding fentanyl

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with pre-existing conditions that could independently affect serum lactate levels.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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GONZALEZ-OJEDA ALEJANDRO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alejandro Gonzalez, 3

Role: PRINCIPAL_INVESTIGATOR

IMSS

Locations

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Centro Médico Nacional de Occidente

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Alejandro Gonzalez, 3

Role: CONTACT

3331294165

Clotilde Fuentes, 1

Role: CONTACT

3331154287

Facility Contacts

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Alejandro González Ojeda, PhD

Role: primary

3336683000

References

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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.

Reference Type BACKGROUND
PMID: 31791558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33990437 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38375661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38148266 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 37846438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34926506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33163386 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37215823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35070281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36408617 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34162242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35995636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32579779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34879822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31356362 (View on PubMed)

Other Identifiers

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Parasternal Blockade 2024

Identifier Type: -

Identifier Source: org_study_id

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