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1. Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery

Author

Edwards M, Forbes G, Berdunov V, Mihaylova B, Dias P, Thomson A, Grocott M, Mythen M, Gillies M, Phan T, Evered L, Wijeysundera D, McCluskey S, Hofer C, Abukhudair H, Szczeklik W, Hajjar L, Kahan B, Pearse R, MacDonald N, Abbott T, Martin T, Januszewska M, Niebrzegowska E, Bekele S, Pates K, Haines R, Walker S, Fowler A, Oliveira M, Whalley J, Stephens T, Amaral V, May S, Manou V, Jones T, Dunkley S, Pakats M, Griffiths B, Fernandez M, Jonas M, Bolger C, Collings N, Burnish R, Kelleher M, Dawson H, Lang A, Campbell R, Rea N, Clark S, Blunt M, Rosbergen M, Hodgson R, Wittenberg M, Filipe H, Gleeson Y, Pakou G, Szakmany T, Gunter U, Hodkinson G, Reay M, Gidda R, Allcock C, Cole A, Watts A, Gardner W, Tindall M, Anumakonda V, Agarwal N, Price T, Clark P, Thompson R, Fowler S, Gray K, McGregor A, Smith T, Wilson T, Guha A, Hodgson A, McSkeane A, Barberis L, Mohamed M, Prentice S, Saunders Z, Ratnam V, Pawa N, Sayan A, Thankachen M, Svensson M, Raj A, Ahmad N, Ivermee C, Cashman J, Smee E, Kanapeckaite L, Corcoran P, Fitzgerald E, Peyton P, Buckley A, Baulch S, Claxton G, Harris S, Sidiropolous S, de Almeida J, Simoes C, Galas F, Camara L, Malbouisson L, Soares S, Fernandes C, Joaquim E, Stefani L, Falcao L, Salgado M, Guimaraes G, Gomes M, Lineburger E, Navarro L, Salles L, Azi L, Prado R, Benedetti R, de Godoy E, Bastos F, da Silva R, dos Santos W, Pazmino-Canizares J, Parotto M, Wasowicz M, Beattie S, Meineri M, Clarke H, Ladha K, Jerath A, Ayach N, Poonawala H, Sellers D, Duncan D, Carroll J, Hudson C, van Vlymen J, Jaeger M, Shelley J, Shore D, McQuaide S, Richebe P, Godin N, Gobert Q, Fortier L, Verdonck O, Sato H, Schricker T, Codere-Maruyama T, Lattermann R, Hatzakorzian R, Moore A, Sato T, Funk D, Kowalski S, Girling L, Monterola M, Fidler K, Sander M, Markmann M, Schulte D, Singer R, Koch C, Ruhrmann S, Habig L, Edinger F, Schneck E, Treskatsch S, Ertmer M, Trauzeddel R, Weyland A, Diers A, Grote T, Pabel S, Lipka A, Nannen L, Fleischer A, Wittmann M, Winkler A, Neumann C, Fingerhut M, Ehrentraut H, Guttenthaler V, Heringlake M, Brandt S, Olsson S, Schmidt C, Schemke S, Murat L, Abu Khudair H, Farhoud E, Ghidan A, Al Masri M, Abu Kwiak S, Abdel-Nabi H, Grigoras I, Ristescu I, Jitaru I, Manole M, Rusu D, Gata A, Aldecoa C, Gonzalez A, Alfonso S, Perz L, Feijoo J, Guerra Y, Herrero A, Ripolles-Melchor J, Abad-Motos A, de Pablo E, Martinez-Hurtado E, Abad-Gurumeta A, Salvachua-Fernandez R, Nozal-Mateo B, de Nadal M, Galan P, Visauta E, Peral E, Da Prat I, Suarez S, Peral C, Una-Orejon R, Caldera-Alvarez M, Fernandez-Francos S, Davila A, Ortola C, Gutierrez A, Mugarra A, Romero E, Soro M, Gracia E, Pozo N, Villafane A, Diez A, Sanchez C, Buron F, Blanco R, Duran M, Parada P, Torres M, Rivas M, Brage S, Castro A, Conde M, Pardal C, Ben M, Perez A, Sancho J, Alarcon M, Mariotti S, Marcolino I, Winter A, McGrane T, Craven D, Turnbo T, Mayo G, Campbell D, Klintworth S, Tilley A, Weinstein M, Horan A, Chowdary R, Carlon V, Balasinorwala T, Yang G, and OPTIMISE II Investigators

Published
2019

2. Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery

Author

Edwards, MR, Forbes, G, MacDonald, N, Berdunov, V, Mihaylova, B, Dias, P, Thomson, A, Grocott, MPW, Mythen, MG, Gillies, MA, Sander, M, Phan, TD, Evered, L, Wijeysundera, DN, McCluskey, SA, Aldecoa, C, Ripolles-Melchor, J, Hofer, CK, Abukhudair, H, Szczeklik, W, Grigoras, I, Hajjar, LA, Kahan, BC, Pearse, RM, Abbott, T, Martin, T, Januszewska, M, Niebrzegowska, E, Bekele, S, Pates, K, Haines, R, Walker, S, Fowler, A, Oliveira, M, Whalley, J, Stephens, T, Amaral, VDS, May, S, Manou, V, Jones, T, Dunkley, S, Pakats, M-L, Griffiths, B, Fernandez, M, Edwards, M, Jonas, M, Bolger, C, Collings, N, Burnish, R, Kelleher, M, Dawson, H, Lang, A, Campbell, R, Rea, N, Clark, S, Blunt, M, Rosbergen, M, Hodgson, R, Wittenberg, M, Filipe, H, Gleeson, Y, Pakou, G, Szakmany, T, Gunter, U, Hodkinson, G, Reay, M, Gidda, R, Allcock, C, Cole, A, Watts, A, Gardner, W, Tindall, M, Anumakonda, V, Agarwal, N, Price, T, Clark, P, Thompson, R, Fowler, S, Gray, K, McGregor, A, Smith, T, Wilson, T, Guha, A, Hodgson, A, McSkeane, A, Barberis, L, Mohamed, M, Prentice, S, Saunders, Z, Ratnam, V, Pawa, N, Sayan, A, Thankachen, M, Svensson, M-L, Raj, A, Ahmad, N, Ivermee, C, Cashman, J, Smee, E, Kanapeckaite, L, Tuong, P, Corcoran, P, Fitzgerald, E, Peyton, P, Buckley, A, Baulch, S, Claxton, G, Harris, S, Sidiropolous, S, de Almeida, JP, Simoes, C, Galas, FRBG, Camara, L, Malbouisson, LMS, Soares, SD, Fernandes, CR, Joaquim, EHG, Stefani, LC, Falcao, LF, Salgado, M, Guimaraes, GN, Gomes, MDA, Lineburger, E, Navarro, L, Salles, LC, Azi, LMTDA, Prado, RG, Benedetti, RH, de Godoy, EP, Bastos, FA, da Silva, RJC, dos Santos, WF, McCluskey, S, Wijeysundera, D, Pazmino-Canizares, J, Parotto, M, Wasowicz, M, Beattie, S, Meineri, M, Clarke, H, Ladha, K, Jerath, A, Ayach, N, Poonawala, H, Sellers, D, Duncan, D, Carroll, J, Hudson, C, van Vlymen, J, Jaeger, M, Shelley, J, Shore, DD, McQuaide, S, Richebe, P, Godin, N, Gobert, Q, Fortier, LP, Verdonck, O, Sato, H, Schricker, T, Codere-Maruyama, T, Lattermann, R, Hatzakorzian, R, Moore, A, Sato, T, Funk, D, Kowalski, S, Girling, L, Monterola, M, Fidler, K, Markmann, M, Schulte, D, Singer, R, Koch, C, Ruhrmann, S, Habig, L, Edinger, F, Schneck, E, Treskatsch, S, Ertmer, M, Trauzeddel, R-F, Weyland, A, Diers, A, Grote, T, Pabel, S, Lipka, A, Nannen, L, Fleischer, A, Wittmann, M, Winkler, A, Neumann, C, Fingerhut, M-L, Ehrentraut, H, Guttenthaler, V, Heringlake, M, Brandt, S, Olsson, S, Schmidt, C, Schemke, S, Murat, L, Abu Khudair, H, Farhoud, E, Ghidan, A, Al Masri, M, Abu Kwiak, S, Abdel-Nabi, H, Ristescu, I, Jitaru, I, Manole, M, Rusu, D, Gata, A, Gonzalez, AP, Alfonso, SM, Perz, LV, Feijoo, JR, Guerra, Y, Herrero, A, Abad-Motos, A, de Pablo, EL, Martinez-Hurtado, E, Abad-Gurumeta, A, Salvachua-Fernandez, R, Nozal-Mateo, B, de Nadal, M, Galan, P, Visauta, EC, Peral, EC, Da Prat, IC, Suarez, SG, Peral, C, Una-Orejon, R, Caldera-Alvarez, MV, Fernandez-Francos, S, Davila, AS, Ortola, CF, Gutierrez, A, Mugarra, A, Romero, E, Soro, M, Gracia, E, Pozo, N, Villafane, AP, Diez, AF, Sanchez, CGM, Buron, FD, Blanco, RP, Duran, MV, Parada, PD, Torres, MB, Rivas, MC, Brage, SM, Castro, AMG, Conde, MJP, Pardal, CB, Ben, MRT, Perez, A, Sancho, JM, Alarcon, MM, Hofer, C, Mariotti, S, Marcolino, I, Winter, A, McGrane, T, Craven, D, Turnbo, T, Mayo, G, Campbell, D, Klintworth, S, Tilley, A, Weinstein, M, Horan, A, Chowdary, R, Carlon, VA, Balasinorwala, T, Yang, G, Edwards, MR, Forbes, G, MacDonald, N, Berdunov, V, Mihaylova, B, Dias, P, Thomson, A, Grocott, MPW, Mythen, MG, Gillies, MA, Sander, M, Phan, TD, Evered, L, Wijeysundera, DN, McCluskey, SA, Aldecoa, C, Ripolles-Melchor, J, Hofer, CK, Abukhudair, H, Szczeklik, W, Grigoras, I, Hajjar, LA, Kahan, BC, Pearse, RM, Abbott, T, Martin, T, Januszewska, M, Niebrzegowska, E, Bekele, S, Pates, K, Haines, R, Walker, S, Fowler, A, Oliveira, M, Whalley, J, Stephens, T, Amaral, VDS, May, S, Manou, V, Jones, T, Dunkley, S, Pakats, M-L, Griffiths, B, Fernandez, M, Edwards, M, Jonas, M, Bolger, C, Collings, N, Burnish, R, Kelleher, M, Dawson, H, Lang, A, Campbell, R, Rea, N, Clark, S, Blunt, M, Rosbergen, M, Hodgson, R, Wittenberg, M, Filipe, H, Gleeson, Y, Pakou, G, Szakmany, T, Gunter, U, Hodkinson, G, Reay, M, Gidda, R, Allcock, C, Cole, A, Watts, A, Gardner, W, Tindall, M, Anumakonda, V, Agarwal, N, Price, T, Clark, P, Thompson, R, Fowler, S, Gray, K, McGregor, A, Smith, T, Wilson, T, Guha, A, Hodgson, A, McSkeane, A, Barberis, L, Mohamed, M, Prentice, S, Saunders, Z, Ratnam, V, Pawa, N, Sayan, A, Thankachen, M, Svensson, M-L, Raj, A, Ahmad, N, Ivermee, C, Cashman, J, Smee, E, Kanapeckaite, L, Tuong, P, Corcoran, P, Fitzgerald, E, Peyton, P, Buckley, A, Baulch, S, Claxton, G, Harris, S, Sidiropolous, S, de Almeida, JP, Simoes, C, Galas, FRBG, Camara, L, Malbouisson, LMS, Soares, SD, Fernandes, CR, Joaquim, EHG, Stefani, LC, Falcao, LF, Salgado, M, Guimaraes, GN, Gomes, MDA, Lineburger, E, Navarro, L, Salles, LC, Azi, LMTDA, Prado, RG, Benedetti, RH, de Godoy, EP, Bastos, FA, da Silva, RJC, dos Santos, WF, McCluskey, S, Wijeysundera, D, Pazmino-Canizares, J, Parotto, M, Wasowicz, M, Beattie, S, Meineri, M, Clarke, H, Ladha, K, Jerath, A, Ayach, N, Poonawala, H, Sellers, D, Duncan, D, Carroll, J, Hudson, C, van Vlymen, J, Jaeger, M, Shelley, J, Shore, DD, McQuaide, S, Richebe, P, Godin, N, Gobert, Q, Fortier, LP, Verdonck, O, Sato, H, Schricker, T, Codere-Maruyama, T, Lattermann, R, Hatzakorzian, R, Moore, A, Sato, T, Funk, D, Kowalski, S, Girling, L, Monterola, M, Fidler, K, Markmann, M, Schulte, D, Singer, R, Koch, C, Ruhrmann, S, Habig, L, Edinger, F, Schneck, E, Treskatsch, S, Ertmer, M, Trauzeddel, R-F, Weyland, A, Diers, A, Grote, T, Pabel, S, Lipka, A, Nannen, L, Fleischer, A, Wittmann, M, Winkler, A, Neumann, C, Fingerhut, M-L, Ehrentraut, H, Guttenthaler, V, Heringlake, M, Brandt, S, Olsson, S, Schmidt, C, Schemke, S, Murat, L, Abu Khudair, H, Farhoud, E, Ghidan, A, Al Masri, M, Abu Kwiak, S, Abdel-Nabi, H, Ristescu, I, Jitaru, I, Manole, M, Rusu, D, Gata, A, Gonzalez, AP, Alfonso, SM, Perz, LV, Feijoo, JR, Guerra, Y, Herrero, A, Abad-Motos, A, de Pablo, EL, Martinez-Hurtado, E, Abad-Gurumeta, A, Salvachua-Fernandez, R, Nozal-Mateo, B, de Nadal, M, Galan, P, Visauta, EC, Peral, EC, Da Prat, IC, Suarez, SG, Peral, C, Una-Orejon, R, Caldera-Alvarez, MV, Fernandez-Francos, S, Davila, AS, Ortola, CF, Gutierrez, A, Mugarra, A, Romero, E, Soro, M, Gracia, E, Pozo, N, Villafane, AP, Diez, AF, Sanchez, CGM, Buron, FD, Blanco, RP, Duran, MV, Parada, PD, Torres, MB, Rivas, MC, Brage, SM, Castro, AMG, Conde, MJP, Pardal, CB, Ben, MRT, Perez, A, Sancho, JM, Alarcon, MM, Hofer, C, Mariotti, S, Marcolino, I, Winter, A, McGrane, T, Craven, D, Turnbo, T, Mayo, G, Campbell, D, Klintworth, S, Tilley, A, Weinstein, M, Horan, A, Chowdary, R, Carlon, VA, Balasinorwala, T, and Yang, G

Abstract

INTRODUCTION: Postoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery. Previous small trials of cardiac-output-guided haemodynamic therapy algorithms suggested a modest reduction in postoperative morbidity. A large definitive trial is needed to confirm or refute this and inform widespread clinical practice. METHODS: The Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial is a multicentre, international, parallel group, open, randomised controlled trial. 2502 high-risk patients undergoing major elective gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intravenous fluid combined with low-dose inotrope infusion, or usual care. The trial intervention will be carried out during and for 4 hours after surgery. The primary outcome is postoperative infection of Clavien-Dindo grade II or higher within 30 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation; however, outcome assessors will be blinded when feasible. Participant recruitment started in January 2017 and is scheduled to last 3 years, within 50 hospitals worldwide. ETHICS/DISSEMINATION: The OPTIMISE II trial has been approved by the UK National Research Ethics Service and has been approved by responsible ethics committees in all participating countries. The findings will be disseminated through publication in a widely accessible peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: ISRCTN39653756.

Published
2019

4. Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial.

Author

Khan JS, Gilron I, Devereaux PJ, Clarke H, Ayach N, Tomlinson G, Quan ML, Ladha KS, Choi S, Munro A, Brull R, Lim DW, Avramescu S, Richebé P, Hodgson N, Paul J, McIsaac DI, Derzi S, Zbitnew GL, Easson AM, Siddiqui NT, Miles SJ, and Karkouti K

Subjects
Humans, Female, Infusions, Intravenous, Treatment Outcome, Pain Measurement, Quality of Life, Chronic Pain prevention & control, Chronic Pain etiology, Mastectomy, Segmental adverse effects, Time Factors, Analgesics, Opioid administration & dosage, Analgesics, Opioid therapeutic use, Analgesics, Opioid adverse effects, Cost-Benefit Analysis, Lidocaine administration & dosage, Lidocaine adverse effects, Breast Neoplasms surgery, Pain, Postoperative prevention & control, Pain, Postoperative etiology, Pain, Postoperative diagnosis, Mastectomy adverse effects, Anesthetics, Local administration & dosage, Anesthetics, Local adverse effects, Multicenter Studies as Topic, Randomized Controlled Trials as Topic
Abstract

Background: Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery., Methods: PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness., Discussion: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients., Trial Registration: This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021)., (© 2024. The Author(s).)

Published
2024
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5. In-hospital opioid consumption, but not pain intensity scores, predicts 6-month levels of pain catastrophizing following hepatic resection: A trajectory analysis.

Author

Pagé MG, Karanicolas PJ, Cleary S, Wei AC, McHardy P, Ladak SSJ, Ayach N, Sawyer J, McCluskey SA, Srinivas C, Katz J, Coburn N, Hallet J, Law C, Greig P, and Clarke H

Subjects
Acute Pain etiology, Acute Pain psychology, Aged, Catastrophization psychology, Female, Hospitalization, Humans, Male, Middle Aged, Pain Measurement, Pain, Postoperative etiology, Self Report, Acute Pain drug therapy, Analgesics, Opioid therapeutic use, Catastrophization etiology, Hepatectomy adverse effects, Pain, Postoperative drug therapy, Pain, Postoperative psychology
Abstract

Background: The study aims were to model acute pain intensity and opioid consumption trajectories up to 72 hr after open hepatic resection, identify predictors of trajectory membership and examine the association between trajectory memberships and 6-month pain and psychological outcomes. This is a long-term analysis of a published randomized controlled trial on the impact of medial open transversus abdominis plane catheters on post-operative outcomes., Methods: A total of 152 patients (89 males; mean age 63.0 [range: 54-72]) completed questionnaires on pain and related characteristics pre-operatively and 6 months post-operatively. Total opioid use was recorded several times over a 72-hr period while self-reported pain intensity scores were collected multiple times until hospital discharge. Analyses were carried out using growth mixture modelling, logistic regression and general linear models., Results: Both pain intensity and opioid consumption showed that a four-trajectory model best fits the data. Patients in the lowest opioid consumption trajectory were more likely to be classified in the constant mild pain intensity trajectory. Age and baseline levels of anxiety significantly predicted opioid trajectory membership while baseline depressive symptoms significantly predicted pain intensity trajectory membership. Patients in the two highest opioid consumption trajectories reported significantly higher levels of pain catastrophizing at 6 months compared to patients in the other 3 trajectories (all p < 0.05)., Conclusion: High consumption of opioids after surgery is associated with higher levels of pain catastrophizing 6 months later. Identification of patients within these trajectories may lead to the development of early interventions targeted to high risk individuals., Significance: Differences in initial levels of opioid consumption and rates of change in opioid consumption shortly after surgery can help predict long-term psychological responses to pain. Identifying key characteristics associated with initial opioid consumption can lead to the development of cost-effective early interventions targeted to high risk individuals., (© 2018 European Pain Federation - EFIC®.)

Published
2019
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6. Cardiac output-based fluid optimization for kidney transplant recipients: a proof-of-concept trial.

Author

Corbella D, Toppin PJ, Ghanekar A, Ayach N, Schiff J, Van Rensburg A, and McCluskey SA

Subjects
Adult, Aged, Delayed Graft Function etiology, Echocardiography, Echocardiography, Doppler, Esophagus diagnostic imaging, Female, Humans, Male, Middle Aged, Stroke Volume, Cardiac Output, Fluid Therapy methods, Kidney Transplantation
Abstract

Purpose: Intravenous fluid management for deceased donor kidney transplantation is an important, modifiable risk factor for delayed graft function (DGF). The primary objective of this study was to determine if goal-directed fluid therapy using esophageal Doppler monitoring (EDM) to optimize stroke volume (SV) would alter the amount of fluid given., Methods: This randomized, proof-of-concept trial enrolled 50 deceased donor renal transplant recipients. Data collected included patient characteristics, fluid administration, hemodynamics, and complications. The EDM was used to optimize SV in the EDM group. In the control group, fluid management followed the current standard of practice. The groups were compared for the primary outcome of total intraoperative fluid administered., Results: There was no difference in the mean (standard deviation) volume of intraoperative fluid administered to the 24 control and 26 EDM patients [2,307 (750) mL vs 2,675 (842) mL, respectively; mean difference, 368 mL; 95% confidence interval (CI), - 87 to + 823; P = 0.11]. The incidence of complications in the control and EDM groups was similar (15/24 vs 17/26, respectively; P = 0.99), as was the incidence of delayed graft failure (8/24 vs 11/26, respectively; P = 0.36)., Conclusions: Goal-directed fluid therapy did not alter the volume of fluid administered or the incidence of complications. This proof-of-concept trial provides needed data for conducting a larger trial to determine the influence of fluid therapy on the incidence in DGF in deceased donor kidney transplantation., Trial Registration: www.clinicaltrials.gov (NCT02512731). Registered 31 July 2015.

Published
2018
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