NCT04810494

Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	2% Lidocaine HCl topical solution	0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device.
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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-03-31
• Completion: 2023-06-30
• First posted: 2021-03-23
• Last updated: 2022-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study