Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.

NCT04810494 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY00016664
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative nausea and vomiting; Intranasal lidocaine

Outcome Measures

Primary Outcomes (1)

• Incidence

  The incidence of nausea and/or vomiting will be measured by asking the nurse and patient.

  up to 1 day

Secondary Outcomes (6)

• Duration of nausea and/or vomiting

  up to 1 day

• Rescue treatments

  up to 1 day

• Duration of stay in PACU.

  up to 1 day

• Patient satisfaction

  At 6 hours after surgery or discharge home, whichever occurs first

• Intensity

  At 6 hours after surgery or discharge home, whichever occurs first

Study Arms (2)

test drug

EXPERIMENTAL

2% Lidocaine

Drug: 2% Lidocaine HCl topical solution

Placebo

PLACEBO COMPARATOR

0.9% Normal Saline

Drug: 0.9% Sodium chloride

Interventions

2% Lidocaine HCl topical solution DRUG

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

test drug

0.9% Sodium chloride DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (12)

• 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.

  PMID: 28455599 BACKGROUND

• 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.

  PMID: 25638733 BACKGROUND

• 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.

  PMID: 30718165 BACKGROUND

• 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.

  PMID: 31000893 BACKGROUND

• 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.

  PMID: 30283168 BACKGROUND

• 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.

  PMID: 16846542 BACKGROUND

• 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.

  PMID: 30303542 BACKGROUND

• 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.

  PMID: 21061107 BACKGROUND

• 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.

  PMID: 29864216 BACKGROUND

• 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.

  PMID: 27199310 BACKGROUND

• 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.

  PMID: 20037151 BACKGROUND

• 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.

  PMID: 10958095 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Marc Royo, MD

  Penn State Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 23, 2021
• Study Start: October 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

US (1)