Evaluation of Intravenous Lidocaine and Time to Regression of the Sensory Block After Spinal Anesthesia (ELSA Trial)

Summary

The use of intravenous lidocaine in continuous infusion in the perioperative period is associated with a reduction in postoperative pain scores, opioid use, incidence of nausea and vomiting, among other favorable outcomes. However, this therapeutic intervention has not yet been adequately evaluated by clinical trials when associated with regional anesthesia. The aim of this study is to evaluate whether the use of intravenous lidocaine in continuous infusion during spinal anesthesia with isobaric bupivacaine alters the time to regression of sensory block in patients undergoing surgical procedures for the treatment of bone and connective tissue tumor surgeries. This will be a triple-blind randomized trial. The sample size estimated was 66 patients. The study will include all patients who meet the pre-established inclusion and exclusion criteria, choose to participate, and agree with the Informed Consent Form. The main anesthetic technique will be spinal anesthesia with 13 mg of isobaric bupivacaine. Patients will be allocated in two groups in a blindly after randomization: Group S (lidocaine 0.75mg.kg-1 in bolus followed by infusion of saline solution) and Group L (lidocaine 1.5 mg.kg-1 followed by continuous infusion of lidocaine solution at 2 mg.kg-1.h-1). The primary outcome will be the time to T12 regression of the sensory block. Will also be evaluated: time to regression of the motor block, most rostral dermatome achieved by the sensory block, time to two-segment regression oh the sensory block, propofol dose in the operating room, postoperative pain score at rest, pain at movement score, quality of recovery, use of opioids in the postoperative period, nausea or vomiting, dizziness, shivering, arrhythmias, hypotension, urinary retention, and length of stay. The records will be assigned to the RedCap database. The data will be extracted without identification of the allocation groups for the R software and the groups will be revealed to the researcher after the end of the statistical analysis to write the summary of the results. The results will be submitted to scientific journals afterward.

Timeline

Start

2021-06-17

Primary completion

2022-12

Completion

2023-12

Publications

• Background Miller RD. Miller's Anesthesia. 7th ed. Phyladelphia: Churchill Livingstone/Elsevier; 2010.
• Background Imbelloni LE, Moreira AD, Gaspar FC, Gouveia MA, Cordeiro JA. Assessment of the densities of local anesthetics and their combination with adjuvants: an experimental study. Rev Bras Anestesiol. 2009 Mar-Apr;59(2):154-65. doi: 10.1590/s0034-70942009000200003. English, Portuguese.
• Background Lui AC, Polis TZ, Cicutti NJ. Densities of cerebrospinal fluid and spinal anaesthetic solutions in surgical patients at body temperature. Can J Anaesth. 1998 Apr;45(4):297-303. doi: 10.1007/BF03012018.
• Background Beloeil H. Opioid-free anesthesia. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):353-360. doi: 10.1016/j.bpa.2019.09.002. Epub 2019 Sep 26.
• Background Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb.
• Background Gelineau AM, King MR, Ladha KS, Burns SM, Houle T, Anderson TA. Intraoperative Esmolol as an Adjunct for Perioperative Opioid and Postoperative Pain Reduction: A Systematic Review, Meta-analysis, and Meta-regression. Anesth Analg. 2018 Mar;126(3):1035-1049. doi: 10.1213/ANE.0000000000002469.
• Background Ng KT, Yap JLL, Izham IN, Teoh WY, Kwok PE, Koh WJ. The effect of intravenous magnesium on postoperative morphine consumption in noncardiac surgery: A systematic review and meta-analysis with trial sequential analysis. Eur J Anaesthesiol. 2020 Mar;37(3):212-223. doi: 10.1097/EJA.0000000000001164.
• Background Wang X, Lin C, Lan L, Liu J. Perioperative intravenous S-ketamine for acute postoperative pain in adults: A systematic review and meta-analysis. J Clin Anesth. 2021 Feb;68:110071. doi: 10.1016/j.jclinane.2020.110071. Epub 2020 Oct 26.
• Background Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.
• Background Hermanns H, Hollmann MW, Stevens MF, Lirk P, Brandenburger T, Piegeler T, Werdehausen R. Molecular mechanisms of action of systemic lidocaine in acute and chronic pain: a narrative review. Br J Anaesth. 2019 Sep;123(3):335-349. doi: 10.1016/j.bja.2019.06.014. Epub 2019 Jul 11.
• Background Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.
• Background Ghimire A, Subedi A, Bhattarai B, Sah BP. The effect of intraoperative lidocaine infusion on opioid consumption and pain after totally extraperitoneal laparoscopic inguinal hernioplasty: a randomized controlled trial. BMC Anesthesiol. 2020 Jun 3;20(1):137. doi: 10.1186/s12871-020-01054-2.
• Background Farag E, Ghobrial M, Sessler DI, Dalton JE, Liu J, Lee JH, Zaky S, Benzel E, Bingaman W, Kurz A. Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery. Anesthesiology. 2013 Oct;119(4):932-40. doi: 10.1097/ALN.0b013e318297d4a5.
• Background Choi GJ, Kang H, Ahn EJ, Oh JI, Baek CW, Jung YH, Kim JY. Clinical Efficacy of Intravenous Lidocaine for Thyroidectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. World J Surg. 2016 Dec;40(12):2941-2947. doi: 10.1007/s00268-016-3619-6.
• Background Beaussier M, Delbos A, Maurice-Szamburski A, Ecoffey C, Mercadal L. Perioperative Use of Intravenous Lidocaine. Drugs. 2018 Aug;78(12):1229-1246. doi: 10.1007/s40265-018-0955-x.
• Background Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
• Background Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w.
• Background Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):285-305. doi: 10.1007/s00268-012-1787-6. No abstract available.
• Background Khezri MB, Rajabi M, Yaghoobi S, Barikani A. Effect of intravenous lignocaine infusion on bispectral index during spinal anaesthesia for caesarean section: A prospective randomised double-blind study. Indian J Anaesth. 2020 May;64(5):369-374. doi: 10.4103/ija.IJA_424_19. Epub 2020 May 1.
• Background Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54. doi: 10.7326/0003-4819-145-4-200608150-00004.
• Background Park SK, Lee JH, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Comparison of bupivacaine plus intrathecal fentanyl and bupivacaine alone for spinal anesthesia with intravenous dexmedetomidine sedation: a randomized, double-blind, noninferiority trial. Reg Anesth Pain Med. 2019 Apr;44(4):459-465. doi: 10.1136/rapm-2018-100084. Epub 2019 Jan 23.
• Background Verret M, Lauzier F, Zarychanski R, Perron C, Savard X, Pinard AM, Leblanc G, Cossi MJ, Neveu X, Turgeon AF; Canadian Perioperative Anesthesia Clinical Trials (PACT) Group. Perioperative Use of Gabapentinoids for the Management of Postoperative Acute Pain: A Systematic Review and Meta-analysis. Anesthesiology. 2020 Aug;133(2):265-279. doi: 10.1097/ALN.0000000000003428.

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