Intravenous Lidocaine for Perioperative and Postoperative Analgesia

NCT03921567 | Unknown Phase 4 DMC

• 1 other identifier: UCCKosovo
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief Summary

Postoperative pain continues to be untreated despite the application of multimodal analgesia, medication and new analgesic techniques. Traditional opioid pain treatment has many side effects, while invasive methods, such as epidural catheter, have high costs and difficulties during application. Lidocaine is a local anesthetic and its administration with intravenous routes has analgesic, antihyperalgic and antiinflammatory action. It increases the motility of the intestine and has antiemetic properties. The advantage of this method is the low cost of the preparation and its easy application. The intravenous administration of lidocaine for postoperative analgesia is recently used and not sufficiently researched technique .

Conditions

Analgesic Drug Dependence

Keywords

Analgesia; Perioperative periode; Postoperative periode; VAS scale

Outcome Measures

Primary Outcomes (1)

• Reduction of opiods used during perioperative period and other analgesics used during postoperative period

  The primary outcome measures are: the use of opiods and other analgesics during and 48 hours after the surgical intervention. During the intraoperative period, it will be investigated how the application of intravenous lidocaine will reduce the amount of opiodes used, amd during the postoperative period will be investigated when the application of other analgesics will start and which analgesics will be used as well,how often they will be given and in which dose. The analgesics which will be investigated include routine analgesics found in our hospital: * tramadol * acetaminophen * diclophenac * ketorolac * others

  48 hours after surgical intervention

Secondary Outcomes (1)

• Pain scores measured at rest and during the movement with Visual Analog Scale

  48 hours after surgical intervention

Study Arms (3)

Group I

EXPERIMENTAL

at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.

Drug: Lidocaine Hydrochloride

Group II

ACTIVE COMPARATOR

at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation

Drug: Lidocaine Hydrochloride; Drug: Lidocaine Hydrochloride and Ketamine

The control group

PLACEBO COMPARATOR

will be given opioids during surgery, opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.

Drug: Placebo

Interventions

Lidocaine Hydrochloride DRUG

at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.

Also known as: Lidocaine Hydrochloride ampule

Group I; Group II

Lidocaine Hydrochloride and Ketamine DRUG

at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation

Also known as: Lidocaine Hydrochloride ampule and Ketamine ampule

Group II

Placebo DRUG

will be given opioids during surgery, and opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.

Also known as: Placebo for(lidocaine hydrochloride)

The control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of both genders from 18 to 75 years
• ASA physiological status I-III
• Participation in abdominal, orthopedic, laparoscopical, gynecological and urological interventions.

You may not qualify if:

• Patient rejection
• History of chronic opioid intake
• History of renal, hepatic or psychiatric disorders
• Heart failure,
• Organ transplant history,
• Lidocaine allergy
• Family history of malignant hyperthermia

Sponsors & Collaborators

• Rajmonda Nallbani-Komoni: lead

Study Sites (2)

University Clinical Centre of Kosovo

Pristina, 10000, Kosovo

RECRUITING

University of Pristina, Faculty of Medicine

Pristina, 10000, Kosovo

RECRUITING

Related Publications (20)

• 1. Mendonça* FT, Reis MC, Aguiar JA and Calvano LA Systemic Lidocaine for Perioperative Analgesia: A Literature Review, J Anest & Inten Care Med. 2015;1(1): 555551.

  BACKGROUND

• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

  PMID: 12873949 RESULT

• Tanaka PP, Moss J. The role of peripheral opiate antagonists in pain medicine and perioperative care. Rev Bras Anestesiol. 2008 Sep-Oct;58(5):540-7, 533-9. doi: 10.1590/s0034-70942008000500011. English, Portuguese.

  PMID: 19382412 RESULT

• de Oliveira CM, Issy AM, Sakata RK. Intraoperative intravenous lidocaine. Rev Bras Anestesiol. 2010 May-Jun;60(3):325-33. doi: 10.1016/S0034-7094(10)70041-6.

  PMID: 20682165 RESULT

• Lauretti GR. Mechanisms of analgesia of intravenous lidocaine. Rev Bras Anestesiol. 2008 May-Jun;58(3):280-6. doi: 10.1590/s0034-70942008000300011. English, Portuguese.

  PMID: 19378524 RESULT

• McLure HA, Rubin AP. Review of local anaesthetic agents. Minerva Anestesiol. 2005 Mar;71(3):59-74.

  PMID: 15714182 RESULT

• Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006 Fall;53(3):98-108; quiz 109-10. doi: 10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2.

  PMID: 17175824 RESULT

• Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.

  PMID: 23044681 RESULT

• Mao J, Chen LL. Systemic lidocaine for neuropathic pain relief. Pain. 2000 Jul;87(1):7-17. doi: 10.1016/S0304-3959(00)00229-3.

  PMID: 10863041 RESULT

• Swenson BR, Gottschalk A, Wells LT, Rowlingson JC, Thompson PW, Barclay M, Sawyer RG, Friel CM, Foley E, Durieux ME. Intravenous lidocaine is as effective as epidural bupivacaine in reducing ileus duration, hospital stay, and pain after open colon resection: a randomized clinical trial. Reg Anesth Pain Med. 2010 Jul-Aug;35(4):370-6. doi: 10.1097/AAP.0b013e3181e8d5da.

  PMID: 20588151 RESULT

• 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.

  PMID: 18844267 RESULT

• 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.

  PMID: 21061107 RESULT

• McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.

  PMID: 20518581 RESULT

• 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.

  PMID: 26184397 RESULT

• 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.

  PMID: 16952918 RESULT

• 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.

  PMID: 17197840 RESULT

• Wu CT, Borel CO, Lee MS, Yu JC, Liou HS, Yi HD, Yang CP. The interaction effect of perioperative cotreatment with dextromethorphan and intravenous lidocaine on pain relief and recovery of bowel function after laparoscopic cholecystectomy. Anesth Analg. 2005 Feb;100(2):448-453. doi: 10.1213/01.ANE.0000142551.92340.CC.

  PMID: 15673874 RESULT

• 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.

  PMID: 15041597 RESULT

• 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.

  PMID: 17667496 RESULT

• Saadawy IM, Kaki AM, Abd El Latif AA, Abd-Elmaksoud AM, Tolba OM. Lidocaine vs. magnesium: effect on analgesia after a laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 2010 May;54(5):549-56. doi: 10.1111/j.1399-6576.2009.02165.x. Epub 2009 Nov 16.

  PMID: 19919581 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine; Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Antigona Hasani, Profesor

  University of Pristina, Faculty of Medicine, 10000 Pristina, Kosovo

  STUDY DIRECTOR

Central Study Contacts

Rajmonda Nallbani

CONTACT

+38344188872; rajmonda.nallbani@uni-pr.edu

Antigona Hasani

CONTACT

+38344402781; antigona.hasani@uni-pr.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: April 15, 2019
• Primary Completion: October 30, 2019
• Study Completion: January 30, 2020
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Requestors will be required to sign a Data Access Agreement and then these requests will be reviewed by an Independent Review Panel.

Locations

KO (2)