Intravenous Lignocaine as an Analgesic Adjunct in Adolescent Idiopathic Scoliosis Surgery

NCT04931433 | Completed Phase 4

• 1 other identifier: UM.M/PDR/638/3(151)
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center study comparing the effect of intravenous (IV) Lignocaine given throughout posterior spinal fusion surgery on the reduction of morphine usage during postoperative period in adolescent idiopathic scoliosis (AIS) patients.

Conditions

Adolescent Idiopathic Scoliosis; Analgesia

Keywords

Intravenous Lignocaine; Post-operative pain; Posterior Spinal Fusion; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• To evaluate postoperative morphine consumption at 24 hours

  Amount of patient controlled analgesia (PCA) morphine usage in mg over 24 hours

  Immediately post-operation until 24 hours post-operation

Secondary Outcomes (2)

• To determine the safe dose of intravenous infusion (IVI) lignocaine by measuring the plasma concentration levels

  30 minutes, 2 hours, 4 hours and 8 hours after the bolus dose of trial drug

• To evaluate the effect on propofol dose requirement as measured by processed electroencephalogram (EEG) qCON index

  From the start of anaesthesia until the end of surgery (Throughout the surgery which may range from 2 to 5 hours))

Other Outcomes (8)

• To evaluate the postoperative numeric rating scale (NRS) at rest and during movement

  Immediately after the operation until 48 hours after the operation

• To determine any adverse events or complications following administration of systemic lignocaine until hospital discharge

  The adverse event will be observed from the time of administration of study drug until the participants are discharge from hospital after the operation. (through the perioperative period, an average of 4 days)

• To determine the effect of intravenous infusion (IVI) Lignocaine on postoperative return of bowel function

  The observation will be done by calculating the hours after the surgery (from the start of postoperative time) to the return of passing first flatus as a measure of bowel opening, assessed up to 72 hours, whichever comes first

Study Arms (2)

Lignocaine

EXPERIMENTAL

This arm will receive intravenous Lignocaine bolus and infusion

Drug: Lignocaine

Placebo

PLACEBO COMPARATOR

This arm will receive Normal saline 0.9% bolus and infusion

Drug: Normal saline

Interventions

Lignocaine DRUG

Group A will receive 1.5mg/kg IV lignocaine bolus prior to induction followed by 2mg/kg/hour of lignocaine infusion throughout surgery until wound closure in which the infusion will be halved to 1mg/kg/hour until the end of surgery. The same rate will be infused in the recovery room for another half an hour before participant is discharge.

Also known as: Group A

Lignocaine

Normal saline DRUG

Group B will receive saline of similar volume and rate as Group A

Also known as: Group B

Placebo

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• American Society of Anaesthesiologists (ASA) physical status I and II

You may not qualify if:

• Hypersensitivity to amide local anaesthetics/lignocaine
• Liver disease (alanine aminotransferase, ALT or aspartate aminotransferase, AST more than twice normal)
• Renal impairment (defined as estimated Glomerular Filtration Rate \<= 60ml/min)
• History of cardiac disease/cardiac arrhythmia
• Epilepsy
• Intellectual disability
• Preoperative chronic pain with regular opioid usage

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya

Pantai Valley, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (37)

• Beilin B, Shavit Y, Trabekin E, Mordashev B, Mayburd E, Zeidel A, Bessler H. The effects of postoperative pain management on immune response to surgery. Anesth Analg. 2003 Sep;97(3):822-827. doi: 10.1213/01.ANE.0000078586.82810.3B.

  PMID: 12933409 BACKGROUND

• Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.

  PMID: 9459225 BACKGROUND

• 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 BACKGROUND

• Ben-Shlomo I, Tverskoy M, Fleyshman G, Cherniavsky G. Hypnotic effect of i.v. propofol is enhanced by i.m. administration of either lignocaine or bupivacaine. Br J Anaesth. 1997 Apr;78(4):375-7. doi: 10.1093/bja/78.4.375.

  PMID: 9135355 BACKGROUND

• Himes RS Jr, DiFazio CA, Burney RG. Effects of lidocaine on the anesthetic requirements for nitrous oxide and halothane. Anesthesiology. 1977 Nov;47(5):437-40. doi: 10.1097/00000542-197711000-00010.

  PMID: 911052 BACKGROUND

• Rehberg B, Xiao YH, Duch DS. Central nervous system sodium channels are significantly suppressed at clinical concentrations of volatile anesthetics. Anesthesiology. 1996 May;84(5):1223-33; discussion 27A. doi: 10.1097/00000542-199605000-00025.

  PMID: 8624017 BACKGROUND

• Kim WY, Lee YS, Ok SJ, Chang MS, Kim JH, Park YC, Lim HJ. Lidocaine does not prevent bispectral index increases in response to endotracheal intubation. Anesth Analg. 2006 Jan;102(1):156-9. doi: 10.1213/01.ANE.0000184040.85956.98.

  PMID: 16368822 BACKGROUND

• Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.

  PMID: 15172773 BACKGROUND

• Pandit JJ, Andrade J, Bogod DG, Hitchman JM, Jonker WR, Lucas N, Mackay JH, Nimmo AF, O'Connor K, O'Sullivan EP, Paul RG, Palmer JH, Plaat F, Radcliffe JJ, Sury MR, Torevell HE, Wang M, Hainsworth J, Cook TM; Royal College of Anaesthetists; Association of Anaesthetists of Great Britain and Ireland. 5th National Audit Project (NAP5) on accidental awareness during general anaesthesia: summary of main findings and risk factors. Br J Anaesth. 2014 Oct;113(4):549-59. doi: 10.1093/bja/aeu313. Epub 2014 Sep 9.

  PMID: 25204697 BACKGROUND

• Hadley MN, Shank CD, Rozzelle CJ, Walters BC. Guidelines for the Use of Electrophysiological Monitoring for Surgery of the Human Spinal Column and Spinal Cord. Neurosurgery. 2017 Nov 1;81(5):713-732. doi: 10.1093/neuros/nyx466. No abstract available.

  PMID: 29029325 BACKGROUND

• Haghighi SS, Madsen R, Green KD, Oro JJ, Kracke GR. Suppression of motor evoked potentials by inhalation anesthetics. J Neurosurg Anesthesiol. 1990 Jun;2(2):73-8. doi: 10.1097/00008506-199006000-00003.

  PMID: 15815324 BACKGROUND

• Huotari AM, Koskinen M, Suominen K, Alahuhta S, Remes R, Hartikainen KM, Jantti V. Evoked EEG patterns during burst suppression with propofol. Br J Anaesth. 2004 Jan;92(1):18-24. doi: 10.1093/bja/aeh022.

  PMID: 14665548 BACKGROUND

• Oliveira CM, Sakata RK, Slullitel A, Salomao R, Lanchote VL, Issy AM. [Effect of intraoperative intravenous lidocaine on pain and plasma interleukin-6 in patients undergoing hysterectomy]. Rev Bras Anestesiol. 2015 Mar-Apr;65(2):92-8. doi: 10.1016/j.bjan.2013.07.017. Epub 2014 Nov 7. Portuguese.

  PMID: 25740274 BACKGROUND

• Kurabe M, Furue H, Kohno T. Intravenous administration of lidocaine directly acts on spinal dorsal horn and produces analgesic effect: An in vivo patch-clamp analysis. Sci Rep. 2016 May 18;6:26253. doi: 10.1038/srep26253.

  PMID: 27188335 BACKGROUND

• Kandil E, Melikman E, Adinoff B. Lidocaine Infusion: A Promising Therapeutic Approach for Chronic Pain. J Anesth Clin Res. 2017 Jan;8(1):697. doi: 10.4172/2155-6148.1000697. Epub 2017 Jan 11.

  PMID: 28239510 BACKGROUND

• Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.

  PMID: 16139163 BACKGROUND

• Chan CYW, Kwan MK. Perioperative Outcome in Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis: A Prospective Study Comparing Single Versus Two Attending Surgeons Strategy. Spine (Phila Pa 1976). 2016 Jun;41(11):E694-E699. doi: 10.1097/BRS.0000000000001349.

  PMID: 26656053 BACKGROUND

• Kwan MK, Chan CY. Does a dual attending surgeon strategy confer additional benefit for posterior selective thoracic fusion in Lenke 1 and 2 adolescent idiopathic scoliosis (AIS)? A prospective propensity matching score analysis. Spine J. 2017 Feb;17(2):224-229. doi: 10.1016/j.spinee.2016.09.005. Epub 2016 Sep 5.

  PMID: 27609611 BACKGROUND

• Miyabe M, Kakiuchi Y, Kihara S, Takahashi S, Kohda Y, Sato S, Toyooka H. The plasma concentration of lidocaine's principal metabolite increases during continuous epidural anesthesia in infants and children. Anesth Analg. 1998 Nov;87(5):1056-7. doi: 10.1097/00000539-199811000-00016. No abstract available.

  PMID: 9806683 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.

  PMID: 23681143 RESULT

• Grassi P, Bregant GM, Crisman M. Systemic intravenous lidocaine for perioperative pain management: a call for changing indications in the package sheet. Heart Lung Vessel. 2014;6(2):137-8. No abstract available.

  PMID: 25024999 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

• 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

• Greenwood E, Nimmo S, Paterson H, Homer N, Foo I. Intravenous lidocaine infusion as a component of multimodal analgesia for colorectal surgery-measurement of plasma levels. Perioper Med (Lond). 2019 Feb 26;8:1. doi: 10.1186/s13741-019-0112-4. eCollection 2019.

  PMID: 30858969 RESULT

• Both CP, Thomas J, Buhler PK, Schmitz A, Weiss M, Piegeler T. Factors associated with intravenous lidocaine in pediatric patients undergoing laparoscopic appendectomy - a retrospective, single-centre experience. BMC Anesthesiol. 2018 Jul 18;18(1):88. doi: 10.1186/s12871-018-0545-1.

  PMID: 30021507 RESULT

• Choi SJ, Kim MH, Jeong HY, Lee JJ. Effect of intraoperative lidocaine on anesthetic consumption, and bowel function, pain intensity, analgesic consumption and hospital stay after breast surgery. Korean J Anesthesiol. 2012 May;62(5):429-34. doi: 10.4097/kjae.2012.62.5.429. Epub 2012 May 24.

  PMID: 22679539 RESULT

• Bazin P, Padley J, Ho M, Stevens J, Ben-Menachem E. The effect of intravenous lidocaine infusion on bispectral index during major abdominal surgery. J Clin Monit Comput. 2018 Jun;32(3):533-539. doi: 10.1007/s10877-017-0035-x. Epub 2017 Jun 16.

  PMID: 28623471 RESULT

• Altermatt FR, Bugedo DA, Delfino AE, Solari S, Guerra I, Munoz HR, Cortinez LI. Evaluation of the effect of intravenous lidocaine on propofol requirements during total intravenous anaesthesia as measured by bispectral index. Br J Anaesth. 2012 Jun;108(6):979-83. doi: 10.1093/bja/aes097. Epub 2012 Apr 6.

  PMID: 22490315 RESULT

• Weber U, Krammel M, Linke S, Hamp T, Stimpfl T, Reiter B, Plochl W. Intravenous lidocaine increases the depth of anaesthesia of propofol for skin incision--a randomised controlled trial. Acta Anaesthesiol Scand. 2015 Mar;59(3):310-8. doi: 10.1111/aas.12462. Epub 2015 Jan 13.

  PMID: 25582611 RESULT

• Cui W, Li Y, Li S, Wang R, Li J. Systemic administration of lidocaine reduces morphine requirements and postoperative pain of patients undergoing thoracic surgery after propofol-remifentanil-based anaesthesia. Eur J Anaesthesiol. 2010 Jan;27(1):41-6. doi: 10.1097/EJA.0b013e32832d5426.

  PMID: 19478674 RESULT

• Hans GA, Lauwick SM, Kaba A, Bonhomme V, Struys MM, Hans PC, Lamy ML, Joris JL. Intravenous lidocaine infusion reduces bispectral index-guided requirements of propofol only during surgical stimulation. Br J Anaesth. 2010 Oct;105(4):471-9. doi: 10.1093/bja/aeq189. Epub 2010 Jul 21.

  PMID: 20650919 RESULT

• Senturk M, Pembeci K, Menda F, Ozkan T, Gucyetmez B, Tugrul M, Camci E, Akpir K. Effects of intramuscular administration of lidocaine or bupivacaine on induction and maintenance doses of propofol evaluated by bispectral index. Br J Anaesth. 2002 Dec;89(6):849-52. doi: 10.1093/bja/aef287.

  PMID: 12453928 RESULT

• Chen Z. The effects of isoflurane and propofol on intraoperative neurophysiological monitoring during spinal surgery. J Clin Monit Comput. 2004 Aug;18(4):303-8. doi: 10.1007/s10877-005-5097-5.

  PMID: 15779842 RESULT

• Urban MK, Fields K, Donegan SW, Beathe JC, Pinter DW, Boachie-Adjei O, Emerson RG. A randomized crossover study of the effects of lidocaine on motor- and sensory-evoked potentials during spinal surgery. Spine J. 2017 Dec;17(12):1889-1896. doi: 10.1016/j.spinee.2017.06.024. Epub 2017 Jun 27.

  PMID: 28666848 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

• Ibrahim A, Aly M, Farrag W. Effect of intravenous lidocaine infusion on long-term postoperative pain after spinal fusion surgery. Medicine (Baltimore). 2018 Mar;97(13):e0229. doi: 10.1097/MD.0000000000010229.

  PMID: 29595671 RESULT

• Maheshwari K, Avitsian R, Sessler DI, Makarova N, Tanios M, Raza S, Traul D, Rajan S, Manlapaz M, Machado S, Krishnaney A, Machado A, Rosenquist R, Kurz A. Multimodal Analgesic Regimen for Spine Surgery: A Randomized Placebo-controlled Trial. Anesthesiology. 2020 May;132(5):992-1002. doi: 10.1097/ALN.0000000000003143.

  PMID: 32235144 RESULT

Related Links

• Depth of anaesthesia monitors - Bispectral Index (BIS), E-Entropy and Narcotrend-Compact M

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mohd Shahnaz Hasan, Postgraduate

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The medications will be prepared before induction by a nurse or doctor who is neither a member of the trial team and later handed to the anaesthetist in charge of the administration according to the trial protocol. The trial drugs are prepared in a 10-ml syringe for the bolus injection and a 50-ml syringe for continuous infusion. For the bolus injection, IV lignocaine 1% will be drawn into the 10-ml syringe will lignocaine 1% solution according to the weight of the patient (0.15ml/kg) or an equal amount of 0.9% saline. The 50-ml syringe contained either 50ml of lignocaine 1% solution or 0.9% normal saline solution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A, Lignocaine and Group B, placebo. Group A will receive 1.5 mg/kg IV lignocaine bolus prior to induction followed by 2mg/kg/hour of lignocaine infusion throughout surgery until wound closure in which the infusion rate will be halved to 1 mg/kg/hour until the end of surgery. This same rate will be infused in the recovery room for another half an hour before patient discharge. Group B will receive saline of similar volume and rate as for Group A.

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: June 18, 2021
• Study Start: December 24, 2020
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)