Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.

Penn State Health

Status and phase: Withdrawn; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: 0.9% Sodium chloride; Drug: 2% Lidocaine HCl topical solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04810494

STUDY00016664

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adults ≥18 years of age
2. ASA Physical status I-III
3. Ability to provide informed consent
4. Pre-surgical COVID-19 negative test
5. Elective, non-cardiac surgery under general anesthesia including breast surgery, gynecologic surgery, and minimally invasive abdominal surgery

Exclusion criteria

1. Local anesthetic allergy
2. Liver diseases
3. Pregnancy
4. Current tobacco use
5. Pre-existing disorders of the gastrointestinal tract
6. Use of anti-emetics within 48 h prior to surgery
7. Chronic use of anti-cholinergic medication or chronic treatment with opioids
8. Any history of nasal pathology (e.g. Nasal ulcer, polyps, and rhinitis)
9. Actual surgical time of <30 min or >180 min
10. Recovery from anesthesia in any location other than PACU
11. History of PONV
12. History of motion sickness
13. Receiving regional blocks for pain management
14. Use of total intravenous anesthesia (TIVA) and/or propofol infusion throughout the case
15. Aprepitant (Emend) administration
16. Non-English speaking patients

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

test drug

Experimental group

Description:

2% Lidocaine

Treatment:

Drug: 2% Lidocaine HCl topical solution

Placebo

Placebo Comparator group

Description:

0.9% Normal Saline

Treatment:

Drug: 0.9% Sodium chloride