Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.

Study Overview
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Brief Summary
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Postoperative nausea and vomiting (PONV) are common and continue to be persistent problems following general anesthesia. Intranasal lidocaine has been used for the treatment of migraine. The theoretical basis for this effect of intranasal lidocaine on migraine relief is reported to be due to its action on the sodium receptors within the sphenopalatine ganglion. Although there is no reported association between PONV and migraines, injecting lidocaine within the sphenopalatine ganglion has proven to be effective in reducing PONV in endoscopic sinus surgery. The purpose of this study is to investigate the efficacy of intranasal 2% lidocaine in preventing PONV.

Detailed Description
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Postoperative nausea and vomiting (PONV) is a common complication following general anesthesia.[1] In the absence of prophylaxis, it can occur in greater than one third of the patients undergoing surgery, and the incidence is even higher in patients with predisposing risk factors.[2] Surgical procedures that have been shown to be associated with a high incidence of PONV include breast, gynecologic, abdominal, and thyroid surgeries.[3-5] Although PONV usually resolves with treatment, its occurrence can increase postoperative morbidity, increase hospital cost, and prolong hospital length of stay.[1-6]Despite numerous available prophylactic treatments and proposed strategies, the incidence of PONV continue to be high given its complex pathogenesis.[1] Lidocaine is a local anesthetic and its intravenous administration has been used as an adjuvant for the treatment of postoperative pain.[7] Intranasal lidocaine has also been used for the treatment of pain, specifically migraine, with significant relief of nausea.[8] The theoretical basis for this effect of intranasal lidocaine on migraine relief is reported to be due to its action on the sodium receptors within the sphenopalatine ganglion.[9] Although there is no reported association between PONV and migraines, injecting lidocaine within the sphenopalatine ganglion has proven to be effective in reducing PONV in patients undergoing endoscopic sinus surgery.[10] Due to the complex mechanism of PONV, proven benefits of lidocaine on pain and possibly nausea, and previously shown benefit of sphenopalatine block in reducing PONV, we hypothesize that intranasal lidocaine could provide effective prophylaxis for PONV.

Official Title
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Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting. A Prospective Double Blind Randomized Controlled Study.

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: 2% Lidocaine HCl topical solution
* Drug: 0.9% Sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 years of age ASA Physical status I-III Ability to provide informed consent Pre-surgical COVID-19 negative test Elective, non-cardiac surgery under general anesthesia including breast surgery, gynecologic surgery, and minimally invasive abdominal surgery Exclusion Criteria: Local anesthetic allergy Liver diseases Pregnancy Current tobacco use Pre-existing disorders of the gastrointestinal tract Use of anti-emetics within 48 h prior to surgery Chronic use of anti-cholinergic medication or chronic treatment with opioids Any history of nasal pathology (e.g. Nasal ulcer, polyps, and rhinitis) Actual surgical time of <30 min or >180 min Recovery from anesthesia in any location other than PACU History of PONV History of motion sickness Receiving regional blocks for pain management Use of total intravenous anesthesia (TIVA) and/or propofol infusion throughout the case Aprepitant (Emend) administration Non-English speaking patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test drug<br>2% Lidocaine | Drug: 2% Lidocaine HCl topical solution<br>* 0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device.<br>|
| Placebo Comparator: Placebo<br>0.9% Normal Saline | Drug: 0.9% Sodium chloride<br>* 0.5mL of 0.9% Sodium chloride (normal saline) will be administered intranasally in each nostril with a mucosal atomization device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence | The incidence of nausea and/or vomiting will be measured by asking the nurse and patient. | up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of nausea and/or vomiting | Duration of nausea and/or vomiting as measured by patient report and physician/nursing observation. This will take place during PACU phase 1. | up to 1 day | 
| Rescue treatments | Use of pharmacological antiemetics or other rescue treatments for postoperative nausea (PON) or PONV in the PACU (Phase 1). This will include the name of the medications administered, frequency, and doses. | up to 1 day | 
| Duration of stay in PACU. | Duration (in hours) in PACU phase 1 will be recorded, this is typically up to 4 hours. | up to 1 day | 
| Patient satisfaction | The patients will be asked to grade their satisfaction level as very satisfied, satisfied, dissatisfied, or very dissatisfied) | At 6 hours after surgery or discharge home, whichever occurs first | 
| Intensity | Intensity will be measured with the validated PONV intensity scale created by Wengritzky et al.[11] This scale ranges from a value of 0 to 50. Clinically important PONV is defined as total score of 50. | At 6 hours after surgery or discharge home, whichever occurs first | 
| Severity | Severity of PONV will be measured in PACU phase 1. The severity of PONV will be measured as per the scale described by Eberhart et al.[12] [None (absence of nausea and vomiting), mild (the patient suffered only mild nausea), moderate (the patient suffered 1-2 emetic episodes or moderate or severe nausea without exogenous stimulus and anti-emetics were required), and severe (the patient vomited at least once or experienced nausea at least twice, and anti-emetics were required at least once). | up to 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative nausea and vomiting, Intranasal lidocaine