Bariatric Surgery Candidate Clinical Trial
Official title:
Optimum Dosage of Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
Verified date | October 2021 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 28, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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McMaster University | St. Joseph's Healthcare Hamilton |
Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight | Feasibility and safety of different dosing schedules | 5 days | |
Secondary | Amount of intraoperative narcotics used post-surgery | Morphine equivalents in mg of narcotic used | 1 day | |
Secondary | Pain scores | Using visual analogue scale | 2 days | |
Secondary | Enhancement of gastrointestinal recovery | Time to first flatus and/or bowel movement and incidence of paralytic ileus | 24 hours | |
Secondary | Post-operative nausea and vomiting | Using 0-4 nausea and vomiting scale | 24 hours | |
Secondary | Patient satisfaction | Using American Pain society outcome questionnaire | 1 day | |
Secondary | Time of rescue analgesia | Time in minutes for participant to request for extra pain medication | 24 hours | |
Secondary | Length of stay in recovery room | Time in hours for recovery room stay | 1 day | |
Secondary | Length of hospital stay | Number of days in hospital | 5 days |
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