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

NCT ID: NCT06608290

Last Updated: 2024-09-24

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-09-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parasternal Block Cardiac Surgery Serum Lactate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Blockade

In patients which parasternal block has been applied

Group Type EXPERIMENTAL

parasternal block

Intervention Type PROCEDURE

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

Lactate serum level

Intervention Type DIAGNOSTIC_TEST

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

Control

In patients which parasternal block has not been applied

Group Type EXPERIMENTAL

Lactate serum level

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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parasternal block

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

Intervention Type PROCEDURE

Lactate serum level

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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
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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Clotilde Fuentes-Orozco

Investigador Principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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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, Mexico

Site Status

Countries

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Mexico

References

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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)

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)

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)

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)

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)

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)

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)

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.

Reference Type BACKGROUND
PMID: 38429852 (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)

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)

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)

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)

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)

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)

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)

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)

Other Identifiers

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R-2023-1301-024.

Identifier Type: -

Identifier Source: org_study_id

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