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Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.

NCT ID: NCT04810494

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-06-30

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.

Conditions

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Postoperative Nausea and Vomiting

Keywords

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Postoperative nausea and vomiting Intranasal lidocaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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test drug

2% Lidocaine

Group Type EXPERIMENTAL

2% Lidocaine HCl topical solution

Intervention Type DRUG

0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device.

Placebo

0.9% Normal Saline

Group Type PLACEBO_COMPARATOR

0.9% Sodium chloride

Intervention Type DRUG

0.5mL of 0.9% Sodium chloride (normal saline) will be administered intranasally in each nostril with a mucosal atomization device.

Interventions

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2% Lidocaine HCl topical solution

0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Marc Royo

Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc Royo, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Health

Locations

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Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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Cao X, White PF, Ma H. An update on the management of postoperative nausea and vomiting. J Anesth. 2017 Aug;31(4):617-626. doi: 10.1007/s00540-017-2363-x. Epub 2017 Apr 28.

Reference Type BACKGROUND
PMID: 28455599 (View on PubMed)

Obrink E, Jildenstal P, Oddby E, Jakobsson JG. Post-operative nausea and vomiting: update on predicting the probability and ways to minimize its occurrence, with focus on ambulatory surgery. Int J Surg. 2015 Mar;15:100-6. doi: 10.1016/j.ijsu.2015.01.024. Epub 2015 Jan 29.

Reference Type BACKGROUND
PMID: 25638733 (View on PubMed)

Tabrizi S, Malhotra V, Turnbull ZA, Goode V. Implementation of Postoperative Nausea and Vomiting Guidelines for Female Adult Patients Undergoing Anesthesia During Gynecologic and Breast Surgery in an Ambulatory Setting. J Perianesth Nurs. 2019 Aug;34(4):851-860. doi: 10.1016/j.jopan.2018.10.006. Epub 2019 Feb 1.

Reference Type BACKGROUND
PMID: 30718165 (View on PubMed)

Jeyabalan S, Thampi SM, Karuppusami R, Samuel K. Comparing the efficacy of aprepitant and ondansetron for the prevention of postoperative nausea and vomiting (PONV): A double blinded, randomised control trial in patients undergoing breast and thyroid surgeries. Indian J Anaesth. 2019 Apr;63(4):289-294. doi: 10.4103/ija.IJA_724_18.

Reference Type BACKGROUND
PMID: 31000893 (View on PubMed)

Tahir S, Mir AA, Hameed A. Comparison of Palonosetron with Granisetron for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Abdominal Surgery. Anesth Essays Res. 2018 Jul-Sep;12(3):636-643. doi: 10.4103/aer.AER_84_18.

Reference Type BACKGROUND
PMID: 30283168 (View on PubMed)

Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006 Jun;22(6):1093-9. doi: 10.1185/030079906X104830.

Reference Type BACKGROUND
PMID: 16846542 (View on PubMed)

Masic D, Liang E, Long C, Sterk EJ, Barbas B, Rech MA. Intravenous Lidocaine for Acute Pain: A Systematic Review. Pharmacotherapy. 2018 Dec;38(12):1250-1259. doi: 10.1002/phar.2189. Epub 2018 Nov 9.

Reference Type BACKGROUND
PMID: 30303542 (View on PubMed)

Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.

Reference Type BACKGROUND
PMID: 21061107 (View on PubMed)

Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.

Reference Type BACKGROUND
PMID: 29864216 (View on PubMed)

Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.

Reference Type BACKGROUND
PMID: 27199310 (View on PubMed)

Wengritzky R, Mettho T, Myles PS, Burke J, Kakos A. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010 Feb;104(2):158-66. doi: 10.1093/bja/aep370. Epub 2009 Dec 26.

Reference Type BACKGROUND
PMID: 20037151 (View on PubMed)

Eberhart LH, Seeling W, Ulrich B, Morin AM, Georgieff M. Dimenhydrinate and metoclopramide alone or in combination for prophylaxis of PONV. Can J Anaesth. 2000 Aug;47(8):780-5. doi: 10.1007/BF03019481.

Reference Type BACKGROUND
PMID: 10958095 (View on PubMed)

Other Identifiers

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STUDY00016664

Identifier Type: -

Identifier Source: org_study_id