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Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03095404
Recruitment Status : Not yet recruiting
First Posted : March 29, 2017
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Currently, there are no studies that address the optimum dosage of lidocaine for surgical procedures. Lidocaine is a local anesthetic that is injected to induce anesthesia. Improper or inefficient pain treatment can lead to longer hospital stay, and adverse side effects such as nausea and vomiting. Opioids are the primary drug to treat moderate to severe pain, but are also responsible for nausea and other side effects. Lidocaine has shown to have opioid sparing effects; meaning less opioid use is necessary for pain relief. In this study, we will conduct a clinical trial to assess the difference between different lidocaine dosage schedules to determine the optimum dosage that brings maximum pain relief while minimizing adverse side effects and patient stay. A large benefit in using lidocaine is its documented opioid sparing which allows for minimal drug treatment.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Drug: Low Dose Lidocaine Drug: High Dose Lidocaine Early Phase 1

Detailed Description:

Lidocaine was first discovered from systematic investigations at the Institute of Chemistry at Stockholm. In the early 1940s, Nils Lofgren discovered lidocaine as a potent anesthetic, initially labelled LL30. It was first clinically tested in 1994, and stood up to appraisal as a reliable and highly efficient local anesthetic.

One systematic review found that, depending on the duration of the infusion of lidocaine, significantly different pain ratings resulted. Similarly, a review found low to moderate evidence for an effect of intravenous lidocaine on pain at rest as one of the major predefined outcomes. Interestingly, this was true for a large variation between the bolus doses (1 to 3mg/kg) and continuous infusion regimes (1.5 to 5 mg/kg/h). The variation of doses impacted pain; early and intermediate, postoperative ileus, time to first flatus, and time to first bowel movements/sounds. One study based all medications in the protocol on the dosing body weight [ideal body weight (IBW) + 0.4 x (actual body weight-IBW). Besides an important improvement in overall quality of recovery, subjects had an improvement in the physical comfort, pain, and physical independence subcomponents of the quality of recovery score. Additionally, there was an opioid sparing effect observed in patients undergoing laparoscopic bariatric surgery, making it especially critical due to the limited respiratory reserve of the bariatric population.

Another study assigned subjects in the experimental group to an IV infusion of 2mg/kg per hour of lidocaine, maintained 15 to 30 minutes before skin closure. The study found similar positive effects, improving postoperative analgesia, reducing postoperative opioid requirements, and accelerating the return of the first flatus. Specifically, the investigation found results similar to previous investigations with longer infusion times across a variety of surgical procedures.

Based on the above, there is a call for further research evaluating the optimum dosage of lidocaine infusion in bariatric populations undergoing major surgery. Not only are there a wide variety of positive effects of lidocaine that need to be investigated, but there is a need for precision and sensitivity of dose regimes in a bariatric population susceptible to adverse effects. It is therefore of interest to find an optimal dosage schedule in order to provide anesthesiologists with a standard which maximizes opioid sparing effects, whilst minimizing patient pain, hospital stay, as well as nausea and vomiting.

Given the complexity of this proposed randomized-controlled trial, as well as time and financial limitations, a pilot study was deemed necessary to find out the feasibility and safety of comparing different dosing schedules, rate of patient recruitment, funding necessities, and needs of additional personnel.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Optimum Dosage of Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose Lidocaine
60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
Drug: Low Dose Lidocaine
60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
Other Name: Lidocaine 1% Injectable Solution

Experimental: High Dose Lidocaine
60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
Drug: High Dose Lidocaine
60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
Other Name: Lidocaine 2% Injectable Solution




Primary Outcome Measures :
  1. Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight [ Time Frame: 5 days ]
    Feasibility and safety of different dosing schedules


Secondary Outcome Measures :
  1. Amount of intraoperative narcotics used post-surgery [ Time Frame: 1 day ]
    Morphine equivalents in mg of narcotic used

  2. Pain scores [ Time Frame: 2 days ]
    Using visual analogue scale

  3. Enhancement of gastrointestinal recovery [ Time Frame: 24 hours ]
    Time to first flatus and/or bowel movement and incidence of paralytic ileus

  4. Post-operative nausea and vomiting [ Time Frame: 24 hours ]
    Using 0-4 nausea and vomiting scale

  5. Patient satisfaction [ Time Frame: 1 day ]
    Using American Pain society outcome questionnaire

  6. Time of rescue analgesia [ Time Frame: 24 hours ]
    Time in minutes for participant to request for extra pain medication

  7. Length of stay in recovery room [ Time Frame: 1 day ]
    Time in hours for recovery room stay

  8. Length of hospital stay [ Time Frame: 5 days ]
    Number of days in hospital



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Bariatric patients 18 years or older undergoing major bowel surgery
  • Patient capable to complete informed consent

Exclusion Criteria:

  • Pediatric population
  • Inability to complete informed consent
  • Patient refusal
  • Chronic aspirin or NSAID intake
  • Known allergy to aspirin and/or NSAIDs, or lidocaine
  • History of bronchial asthma requiring intubation
  • Peptic ulceration
  • Coagulopathy
  • Renal insufficiency
  • Opioid abuse
  • Pregnancy
  • Conversion from laparoscopic to open surgery.
  • Other relative contraindications for lidocaine; unstable CAD, Recent MI, Heart Failure, Heart Block, Electrolyte Disturbances, Liver Disease, Cardiac Dysrhythmias, and Seizure Disorders.

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): NCT03095404


Contacts
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Contact: Greg Peachey, MD 905-522-1155 ext 33853 gregpeachey@cogeco.ca
Contact: Toni Tidy, HBSc, CCRA 905-525-9140 ext 21737 tonitidy@mcmaster.ca

Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Greg Peachey, MD McMaster University

Publications:
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03095404    
Other Study ID Numbers: 2198
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Pharmaceutical Solutions
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