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Bariatric Surgery CandidateEarly Phase 1BSurgNCT03095404

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

A Early Phase 1 study testing Low Dose Lidocaine and High Dose Lidocaine in people with Bariatric Surgery Candidate and Bariatric Bowel Surgery, run by McMaster University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Low Dose Lidocaine and High Dose Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
5 Oct 2022to 26 Aug 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

About this study

Official title: Optimum Dosage of Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery

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.

Read the 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.

Being tested
Low Dose Lidocaine, High Dose Lidocaine
Keywords
Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Dose LidocaineDrug

    Also called Lidocaine 1% Injectable Solution

    60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula

  • High Dose LidocaineDrug

    Also called Lidocaine 2% Injectable Solution

    60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula

Study groups in NCT03095404
Study groupRoleWhat they receive
Low Dose LidocaineExperimental60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
Receives: Drug: Low Dose Lidocaine
High Dose LidocaineExperimental60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
Receives: Drug: High Dose Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight

    Feasibility and safety of different dosing schedules

    Measured: 5 days

Secondary outcomes (8)
  1. Amount of intraoperative narcotics used post-surgery

    Morphine equivalents in mg of narcotic used

    Measured: 1 day

  2. Pain scores

    Using visual analogue scale

    Measured: 2 days

  3. Enhancement of gastrointestinal recovery

    Time to first flatus and/or bowel movement and incidence of paralytic ileus

    Measured: 24 hours

  4. Post-operative nausea and vomiting

    Using 0-4 nausea and vomiting scale

    Measured: 24 hours

  5. Patient satisfaction

    Using American Pain society outcome questionnaire

    Measured: 1 day

  6. Time of rescue analgesia

    Time in minutes for participant to request for extra pain medication

    Measured: 24 hours

  7. Length of stay in recovery room

    Time in hours for recovery room stay

    Measured: 1 day

  8. Length of hospital stay

    Number of days in hospital

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2017
  2. Study start5 Oct 2022
  3. Primary completion26 Aug 2025
  4. Study completion26 Aug 2025

Why it stopped: No funding available.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03095404
Sponsor's protocol ID
2198
Acronym
BSurg
Status last verified
Jan 2025
First submitted
21 Feb 2017
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.

    PubMed 22250276
  • 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.

    PubMed 17952107

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Low Dose Lidocaine and High Dose Lidocaine in people with Bariatric Surgery Candidate and Bariatric Bowel Surgery, run by McMaster University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03095404, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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