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Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain

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ClinicalTrials.gov Identifier: NCT04123652
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Allevio Pain Management Clinic

Brief Summary:
As lidocaine and ketamine provide analgesia by acting on different molecular pathways, administering them together may produce synergistic effects, which can allow for using a lower dose of each medication and thereby reducing the corresponding side effects. To the investigator's knowledge, despite the common practice of multimodal analgesia, lidocaine-ketamine infusions have never been studied prospectively in an out of hospital setting to treat neuropathic pain. The aim of the present study is to evaluate the effectiveness of the current routine practice of lidocaine-ketamine infusions conducted at Allevio Pain Management Clinic, a large outpatient community based chronic pain management facility. Lidocaine-ketamine infusions are prescribed to patients that have pain that is considered to be neuropathic for which standard anti-neuropathic medications have been ineffective or poorly tolerated by patients. A prospective longitudinal study.

Condition or disease Intervention/treatment Phase
Chronic Neuropathic Pain and Fibromyalgia Drug: Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992 Phase 4

Detailed Description:

Study objectives

  1. To evaluate effectiveness of lidocaine-ketamine infusions in reducing neuropathic pain, as assessed using the Revised Pain Quality Assessment Scale (PQAS-R) and Short Form Brief Pain Inventory (BPI-SF).
  2. To evaluate the effects of lidocaine-ketamine infusions on the measures of Global Improvement and Satisfaction Score, Pain Self-Efficacy Questionnaire (PSEQ), Pain Catastrophic Scale (PCS), Beck Depression Inventory (BDI), and Patient self-reported perceived duration of effect (PSPDE).
  3. To assess, analyze, and report adverse events

The study will be conducted per IMMPACT recommendations (17). Multi variable parameters will be captured: pain unpleasantness, physical function, emotional function, global improvement and satisfaction with treatment, adverse events and disposition. Additional instruments will be used in the triage process and follow-up (S-LANSS, PSEQ).

Number of subjects: all eligible consecutive patients accepted for lidocaine-ketamine infusions over period of 6 months.

Patients with multi focal and/or non-dermatomal pain with neuropathic component will be included.

Dosing and infusion orders are completed by one of the physician-investigators prior to patient arrival based on body weight, and modified if required after individual evaluation. Based on published literature and clinical impression, higher doses seem to be more effective and result in longer pain relief. Therefore, subsequent infusion doses will be increased to the maximally tolerated doses (i.e. minimal side effects).

Doses will be calculated using the following:

  • Lidocaine - initial dose of 5.0 mg/kg +/- 1.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, not to exceed 7 mg/kg or 600 mg.
  • Ketamine - initial dose of 0.1 mg/kg (based on actual weight) over 45 minutes (rounded to nearest 5 mg, up to maximum 15 mg), increased by 0.1 mg/kg (rounded to nearest 5 mg) each infusion based on tolerability of side effects.

Standard clinic procedure will be followed for completing the infusions and managing side effects. The infusion will be initiated at 360 ml/hour for planned completion in 45 minutes, rate adjusted if side effects develop. Total doses of medication are recorded in the medical record.

Data collection and Management All study tools will be completed by patients online using, or in the clinic RedCap system. RedCap is a mature, secure web application for building and managing online surveys and databases (Vanderbilt University). The system is secured by SSL protocol and data is encrypted. Patients will be contacted via Email with a secure link to RedCap database, or if they would not be able to do it at home research, they can complete the questionnaires with research coordinator's assistant in secure computers at the clinic. Participant will receive reminders about upcoming visits and promoted to complete the follow-up forms. Allevio data protection is also SSL enabled and secured by SHA256, and they are issued by Rapid SSL and purchased through Ceerts4Less.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Patients are assessed for eligibility on their first visit (screening visit); additional visits may be required to address patient questions and collect baseline data. Qualified participants will be scheduled for their 5 infusions at 8 week intervals.

Dosing and infusion orders are completed by one of the physician-investigators prior to patient arrival based on body weight, and modified if required after individual evaluation. Based on published literature and clinical impression, higher doses seem to be more effective and result in longer pain relief. Therefore, subsequent infusion doses will be increased to the maximally tolerated doses (i.e. minimal side effects).

Participants will be asked to complete the follow-up questionnaires every four weeks starting from their first infusion up to 8 times. On their last study visit, 4 weeks following the last infusion, participants will have an exit interview in addition to completing study measures.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain: an Observational Prospective Study
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Lidocaine and ketamine infusion Drug: Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992

An intravenous will be started. • Lidocaine - initial dose of 5.0 mg/kg +/- 1.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, not to exceed 7 mg/kg or 600 mg.

• Ketamine - initial dose of 0.1 mg/kg (based on actual weight) over 45 minutes (rounded to nearest 5 mg, up to maximum 15 mg), increased by 0.1 mg/kg (rounded to nearest 5 mg) each infusion based on tolerability of side effects During the infusion patient will be monitored by another MD for BP, PR, PO2. Patients will not be allowed to drive for 24 hours.

Other Name: ketamine Hydrochloride, Serial# 5751304560, DIN 02246796




Primary Outcome Measures :
  1. Evaluation of effectiveness of lidocaine-ketamine infusions: PQAS-R [ Time Frame: 4 weeks after the first infusion and every 4 weeks up to 36 weeks ]
    Primary outcome measure: relative change on the PQAS-R. Moderate clinically important improvement is considered as 30% reduction (Dworkin et al., 2008)


Secondary Outcome Measures :
  1. Effect of lidocaine and ketamine infusion on BDI [ Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks ]
    Effect of lidocaine and ketamine infusion on Beck's Depression Inventory

  2. Effect of lidocaine and ketamine infusion on PGIC [ Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks ]
    Effect of lidocaine and ketamine infusion on Pain Global Improvement and Satisfaction

  3. Effect of lidocaine and ketamine infusion on BPI [ Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks ]
    Effect of lidocaine and ketamine infusion on Brief Pain Inventory

  4. Effect of lidocaine and ketamine infusion on PQAS-R [ Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks ]
    Effect of lidocaine and ketamine infusion on Revised Pain Quality Assessment Scale

  5. Effect of lidocaine and ketamine infusion on PSEQ [ Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks ]
    Effect of lidocaine and ketamine infusion on Patient Self-Efficacy Questionnaire

  6. Effect of lidocaine and ketamine infusion on PCS [ Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks ]
    Effect of lidocaine and ketamine infusion on Pain Catastrophizing Scale

  7. Effect of lidocaine and ketamine infusion on PSPDE [ Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks ]
    Effect of lidocaine and ketamine infusion on viii. Patient self-reported perceived duration of effect

  8. Effect of lidocaine and ketamine on narcotic consumption [ Time Frame: Baseline to end-of-study up to 36 weeks ]
    Effect of lidocaine and ketamine infusion on narcotic consumption



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Pain duration > 3 months;

Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram;

Failed medical management with at least 2 neuromodulation agents (e.g., gabapentinoids, antidepressants, cannabinoids);

Neuropathic component (12 or more points on S-LANSS);

Exclusion Criteria:

Non-English speakers;

Refusal to sign informed consent;

Allergy to ketamine and/or lidocaine;

Known relative contraindications to ketamine use which include poorly controlled systemic illnesses: hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., psychosis, schizophrenia, dissociative state);

Known contraindication to lidocaine use which include current symptomatic or clinically significant brady- or tachyarrhythmia, systolic blood pressure <90 or >180 mmHg;

Scheduled interventions targeting neuropathic pain: epidural injections, peripheral nerve blocks, Bier block, radiofrequency of dorsal root ganglia and peripheral nerves, additional lidocaine or ketamine infusions;

Newly added analgesic or neuromodulating medications within 30 days;

Recently performed neuromodulating interventions within 90 days;

Previous lidocaine-ketamine, lidocaine or ketamine infusion within 6 months;

Acute intoxication or active illegal substance abuse;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123652


Contacts
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Contact: Ramin Safakish, MD. FRCPC 6474788462 Ramin.Safakish@AllevioClinic.com
Contact: Shadi Babazadeh, MD 6474788462 ext 90 Shadi.Babazadeh@AllevioClinic.com

Locations
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Canada, Ontario
Allevio Pain Management Clinic Recruiting
Toronto, Ontario, Canada, M3B 3S6
Contact: Ramin Safakish, MD. FRCPC    6474788462    Ramin.Safakish@AllevioClinic.com   
Contact: Shadi Babazadeh, MD    6474788462 ext 90    shadi.Babazadeh@AllevioClinic.com   
Principal Investigator: Ramin Safakish, MD. FRCPC         
Sub-Investigator: Imrat Sohanpal, MD. FRCPC         
Sub-Investigator: Rahul Pathak, MD. FRCPC         
Sub-Investigator: Nicole Khetani, MD         
Sub-Investigator: Praveen Ganty, MD         
Sub-Investigator: Ali Mirdamadi, MD         
Sub-Investigator: Shadi Babazadeh, MD         
Sub-Investigator: Andriy Strilchuk, MD. NP         
Sponsors and Collaborators
Allevio Pain Management Clinic
Investigators
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Principal Investigator: Ramin Safakish, MD.FRCPC Allevio Pain Management Clinic

Publications of Results:
Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basáñez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabé E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fèvre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leòn FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2. Erratum in: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].
IASP. (2003). How Prevalent Is Chronic Pain? International Association for the Study of Pain. Retrieved from https://www.iasp-pain.org/files/Content/ContentFolders/Publications2/PainClinicalUpdates/Archives/PCU03-2_1390265045864_38.pdf
IASP. (1994). Part III: Pain Terms, A Current List with Definitions and Notes on Usage. In Classification of Chronic Pain (second ed., pp. 209-214): IASP Press. Retrieved from
Campbell, J. N., & Meyer, R. A. (2006). Mechanisms of neuropathic pain. Neuron, 52(1), 77-92. doi:10.1016/j.neuron.2006.09.021 CDC. (2017a). Opioid Overdose. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/drugoverdose/index.html CDC. (2017b). Prescribing Data. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/drugoverdose/data/prescribing.html

Other Publications:
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Responsible Party: Allevio Pain Management Clinic
ClinicalTrials.gov Identifier: NCT04123652     History of Changes
Other Study ID Numbers: 16124-11:10:3610-082018
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Allevio Pain Management Clinic:
Neuropathic pain
Fibromyalgia
Lidocaine infusion
Ketamine infusion
Chronic pain
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Neuralgia
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General