Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.
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| ClinicalTrials.gov Identifier: NCT04810494 |
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Recruitment Status :
Not yet recruiting
First Posted : March 23, 2021
Last Update Posted : January 19, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Nausea and Vomiting | Drug: 2% Lidocaine HCl topical solution Drug: 0.9% Sodium chloride | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 304 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting. A Prospective Double Blind Randomized Controlled Study. |
| Estimated Study Start Date : | March 1, 2022 |
| Estimated Primary Completion Date : | September 30, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: test drug
2% Lidocaine
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Drug: 2% Lidocaine HCl topical solution
0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device. |
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Placebo Comparator: Placebo
0.9% Normal Saline
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Drug: 0.9% Sodium chloride
0.5mL of 0.9% Sodium chloride (normal saline) will be administered intranasally in each nostril with a mucosal atomization device. |
- Incidence [ Time Frame: up to 1 day ]The incidence of nausea and/or vomiting will be measured by asking the nurse and patient.
- Duration of nausea and/or vomiting [ Time Frame: up to 1 day ]Duration of nausea and/or vomiting as measured by patient report and physician/nursing observation. This will take place during PACU phase 1.
- Rescue treatments [ Time Frame: up to 1 day ]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.
- Duration of stay in PACU. [ Time Frame: up to 1 day ]Duration (in hours) in PACU phase 1 will be recorded, this is typically up to 4 hours.
- Patient satisfaction [ Time Frame: At 6 hours after surgery or discharge home, whichever occurs first ]The patients will be asked to grade their satisfaction level as very satisfied, satisfied, dissatisfied, or very dissatisfied)
- Intensity [ Time Frame: At 6 hours after surgery or discharge home, whichever occurs first ]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.
- Severity [ Time Frame: up to 1 day ]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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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): NCT04810494
| Contact: Marc Royo, MD | 717-531-4264 | mroyo@pennstatehealth.psu.edu |
| United States, Pennsylvania | |
| Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Principal Investigator: | Marc Royo, MD | Penn State Health |
| Responsible Party: | Marc Royo, Assistant Professor, Department of Anesthesiology and Perioperative Medicine, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT04810494 |
| Other Study ID Numbers: |
STUDY00016664 |
| First Posted: | March 23, 2021 Key Record Dates |
| Last Update Posted: | January 19, 2022 |
| Last Verified: | January 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Postoperative nausea and vomiting Intranasal lidocaine |
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Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Postoperative Complications Pathologic Processes Lidocaine 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 |