Perioperative Intravenous Lidocaine in Liver Surgery

Postoperative Pain Clinical Trial

Official title:

Intravenous Lidocaine for Postoperative Recovery in Liver Surgery, a Randomized Double Blinded Placebo-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05153785
• Other study ID #: Lidokain vid leverkirurgi
• Secondary ID: 2019-002361-35
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 15, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Lund University Hospital
• Contact: Emil Östrand, MD
• Phone: +46-(0)46-171000
• Email: emil.ostrand[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized double blinded placebo-controlled study, conducted in Lund, Sweden. Patients will be randomized in two groups, with a ratio of 1:1. The experimental arm will receive intravenous Lidocaine perioperatively, and the Control arm will receive placebo, i.e. normal Saline. Postoperative both arms will get routine pain Control with PCA, Patient Controlled Analgesia with an intravenous Oxycodone-infusion. Outcome-measures will include patients pain intensity scoring, and opioid consumption.

Description:

Patientes will be randozied in blocks of eight.

The experimental arm will receive a bolus of 1,5mg/kg before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. The placebo arm will receive the same amount of normal Saline instead. Pain intensity scoring, measured by Numerical Rating Scale, NRS, will be conducted at 1, 2, 4 hour postoperatively, and each morning and night until discharge, or for a maximum 5 Days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 yy

• Patient planned for minor hepatectomy

• Signed informed consent

Exclusion Criteria:

• Pregnancy

• Cirrosis

• ASA>3

• Elevated liver enzymes

• AV-block >1, without pacemaker

• WHO class >2

• Allergy against Lidocain or other amid-type local anasthesia

• Heart failure

• Epilepsy

• Treatment with class III anti-arythimic medication

• Preoperative ongoing opioid usage

• Use of : Erythromycin, clarithromycin, Fluvoxamine, Cimetidine, ciprofloxacin, antivirala-HIV-läkemedel or imidazol the week before surgery.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Metastases
• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Lidocaine
Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery
• Normal saline
Placebo

Locations

Country	Name	City	State
Sweden	Skåne University Hospital of Lund	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (29)

Baral BK, Bhattarai BK, Rahman TR, Singh SN, Regmi R. Perioperative intravenous lidocaine infusion on postoperative pain relief in patients undergoing upper abdominal surgery. Nepal Med Coll J. 2010 Dec;12(4):215-20. — View Citation

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. — View Citation

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Dale GJ, Phillips S, Falk GL. The analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: a prospective, randomized, double-blind, placebo-controlled trial. Local Reg Anesth. 2016 Dec 2;9:87-93. doi: 10.2147/LRA.S119483. eCollection 2016. — View Citation

De Oliveira GS Jr, Duncan K, Fitzgerald P, Nader A, Gould RW, McCarthy RJ. Systemic lidocaine to improve quality of recovery after laparoscopic bariatric surgery: a randomized double-blinded placebo-controlled trial. Obes Surg. 2014 Feb;24(2):212-8. doi: 10.1007/s11695-013-1077-x. — View Citation

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Drayer DE, Lorenzo B, Werns S, Reidenberg MM. Plasma levels, protein binding, and elimination data of lidocaine and active metabolites in cardiac patients of various ages. Clin Pharmacol Ther. 1983 Jul;34(1):14-22. doi: 10.1038/clpt.1983.122. — View Citation

Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available. — View Citation

Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11. Erratum In: Ann Surg. 2009 Apr;249(4):701. Dijkgraaf, Omarcel G W [corrected to Dijkgraaf, Marcel G W]. — View Citation

Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007. — View Citation

Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE. — View Citation

Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2. — View Citation

Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4. — View Citation

Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375. — View Citation

Martin F, Cherif K, Gentili ME, Enel D, Abe E, Alvarez JC, Mazoit JX, Chauvin M, Bouhassira D, Fletcher D. Lack of impact of intravenous lidocaine on analgesia, functional recovery, and nociceptive pain threshold after total hip arthroplasty. Anesthesiology. 2008 Jul;109(1):118-23. doi: 10.1097/ALN.0b013e31817b5a9b. — View Citation

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Ortiz MP, Godoy MC, Schlosser RS, Ortiz RP, Godoy JP, Santiago ES, Rigo FK, Beck V, Duarte T, Duarte MM, Menezes MS. Effect of endovenous lidocaine on analgesia and serum cytokines: double-blinded and randomized trial. J Clin Anesth. 2016 Dec;35:70-77. doi: 10.1016/j.jclinane.2016.07.021. Epub 2016 Aug 6. — View Citation

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Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0. — View Citation

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Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3. — View Citation

Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd. — View Citation

Yon JH, Choi GJ, Kang H, Park JM, Yang HS. Intraoperative systemic lidocaine for pre-emptive analgesics in subtotal gastrectomy: a prospective, randomized, double-blind, placebo-controlled study. Can J Surg. 2014 Jun;57(3):175-82. doi: 10.1503/cjs.009613. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption at 24 hours	Sum of opioids consumed	24 hours postoperatively
Secondary	Opioid consumption at 48 hours	Sum of opioids consumed	48 hours postoperatively
Secondary	Opioid consumption at 72 hours	Sum of opioids consumed	72 hours postoperatively
Secondary	Opioid consumption at 96 hours	Sum of opioids consumed	96 hours postoperatively
Secondary	Opioid consumption at 120 hours	Sum of opioids consumed	120 hours postoperatively
Secondary	Postoperative pain intensity	Numerical rating scale (NRS) in rest and activity, scale 0-10, 0=no pain, 10=worst imaginable pain	Day 0-5 postoperatively, twice every day
Secondary	Number of participants with Postoperative comlications	Comparition of Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4,5	30 days postoperatively
Secondary	Level of Postoperative comlications	Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4a,4b,5, 0 beeing none and 5 beeng death.	30 days postoperatively
Secondary	Time to return of Bowel function	Time to first flatus and defacation	Day 0-30 postoperatively
Secondary	Number of participants with Postoperative nausea and vomiting	Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"	Day 1-5 postopertively
Secondary	Level of Postoperative nausea and vomiting	Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"	Day 1-5 postopertively
Secondary	Days in hospital	Length of hospital stay	0-90 days postoperatively
Secondary	Level of MEGX concentrations	Concentration of the metabolite "MEGX" in patients blood	Twice during surgery, and once 1 hour after surgery.
Secondary	Level of Lidocaine concentration	Concentration of Lidocaine in patients blood	Twice during surgery, and once 1 hour after surgery.
Secondary	Mortality	death after surgery	30 days postoperatively
Secondary	Rating of Quality of recovery-40	Quality of recovery questionary.	Day 1-5 postoperatively
Secondary	Number of participant with Adverse Events	All adverse events	0-30 days
Secondary	Level of adverse events	All adverse events, classified according to CTCEA	0-30 days
Secondary	Number of participants with Chronic Postsurgical pain	Chronic Postsurgical pain, according to Brief Pain inventory- questionary	3 months after surgery
Secondary	Level of Chronic Postsurgical pain	Chronic Postsurgical pain, according to Brief Pain inventory- questionary	3 months after surgery