Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.

December 8, 2022 updated by: Marc Royo, Milton S. Hershey Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test drug
2% Lidocaine
Drug: 2% Lidocaine HCl topical solution
0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device.
Placebo Comparator: Placebo
0.9% Normal Saline
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence
Time Frame: up to 1 day
The incidence of nausea and/or vomiting will be measured by asking the nurse and patient.
up to 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 day
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.
up to 1 day
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.
up to 1 day
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)
At 6 hours after surgery or discharge home, whichever occurs first
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.
At 6 hours after surgery or discharge home, whichever occurs first
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).
up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Marc Royo, MD, Penn State Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 14, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00016664

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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