Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
Primary Purpose
Bariatric Surgery Candidate
Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Low Dose Lidocaine
High Dose Lidocaine
Sponsored by
About this trial
This is an interventional supportive care trial for Bariatric Surgery Candidate
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low Dose Lidocaine
High Dose Lidocaine
Arm Description
60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
Outcomes
Primary Outcome Measures
Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight
Feasibility and safety of different dosing schedules
Secondary Outcome Measures
Amount of intraoperative narcotics used post-surgery
Morphine equivalents in mg of narcotic used
Pain scores
Using visual analogue scale
Enhancement of gastrointestinal recovery
Time to first flatus and/or bowel movement and incidence of paralytic ileus
Post-operative nausea and vomiting
Using 0-4 nausea and vomiting scale
Patient satisfaction
Using American Pain society outcome questionnaire
Time of rescue analgesia
Time in minutes for participant to request for extra pain medication
Length of stay in recovery room
Time in hours for recovery room stay
Length of hospital stay
Number of days in hospital
Full Information
NCT ID
NCT03095404
First Posted
February 21, 2017
Last Updated
October 1, 2021
Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT03095404
Brief Title
Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
Official Title
Optimum Dosage of Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No funding available.
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose Lidocaine
Arm Type
Experimental
Arm Description
60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
Arm Title
High Dose Lidocaine
Arm Type
Experimental
Arm Description
60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
Intervention Type
Drug
Intervention Name(s)
Low Dose Lidocaine
Other Intervention Name(s)
Lidocaine 1% Injectable Solution
Intervention Description
60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
Intervention Type
Drug
Intervention Name(s)
High Dose Lidocaine
Other Intervention Name(s)
Lidocaine 2% Injectable Solution
Intervention Description
60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
Primary Outcome Measure Information:
Title
Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight
Description
Feasibility and safety of different dosing schedules
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Amount of intraoperative narcotics used post-surgery
Description
Morphine equivalents in mg of narcotic used
Time Frame
1 day
Title
Pain scores
Description
Using visual analogue scale
Time Frame
2 days
Title
Enhancement of gastrointestinal recovery
Description
Time to first flatus and/or bowel movement and incidence of paralytic ileus
Time Frame
24 hours
Title
Post-operative nausea and vomiting
Description
Using 0-4 nausea and vomiting scale
Time Frame
24 hours
Title
Patient satisfaction
Description
Using American Pain society outcome questionnaire
Time Frame
1 day
Title
Time of rescue analgesia
Description
Time in minutes for participant to request for extra pain medication
Time Frame
24 hours
Title
Length of stay in recovery room
Description
Time in hours for recovery room stay
Time Frame
1 day
Title
Length of hospital stay
Description
Number of days in hospital
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Peachey, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22250276
Citation
Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.
Results Reference
background
PubMed Identifier
17952107
Citation
Han PY, Duffull SB, Kirkpatrick CM, Green B. Dosing in obesity: a simple solution to a big problem. Clin Pharmacol Ther. 2007 Nov;82(5):505-8. doi: 10.1038/sj.clpt.6100381.
Results Reference
background
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Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
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