Clinical trial NCT06608290: Paraesternal Blockade and Lactate Serum Levels in Patients with Cardiac Surgery.
Official title: Association Between the Application of Parasternal Blockade and Serum Lactate Level in Trans and Post-anesthetic Stages in Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parasternal Block
Cardiac Surgery
Serum Lactate
Keywords: Parasternal block
cardiac surgery
serum lactate
cardiopulmonary bypass
cardiovascular surgery post-surgical unit
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-09-23
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactate serum levels
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: 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
state: Jalisco
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.