Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.
Primary Purpose
Postoperative Nausea and Vomiting
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
2% Lidocaine HCl topical solution
0.9% Sodium chloride
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Postoperative nausea and vomiting, Intranasal lidocaine
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Non-English speaking patients
Sites / Locations
- Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
test drug
Placebo
Arm Description
2% Lidocaine
0.9% Normal Saline
Outcomes
Primary Outcome Measures
Incidence
The incidence of nausea and/or vomiting will be measured by asking the nurse and patient.
Secondary Outcome Measures
Duration of nausea and/or vomiting
Duration of nausea and/or vomiting as measured by patient report and physician/nursing observation. This will take place during PACU phase 1.
Rescue treatments
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.
Duration of stay in PACU.
Duration (in hours) in PACU phase 1 will be recorded, this is typically up to 4 hours.
Patient satisfaction
The patients will be asked to grade their satisfaction level as very satisfied, satisfied, dissatisfied, or very dissatisfied)
Intensity
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.
Severity
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).
Full Information
NCT ID
NCT04810494
First Posted
March 14, 2021
Last Updated
December 8, 2022
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04810494
Brief Title
Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.
Official Title
Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting. A Prospective Double Blind Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Change in study team
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Postoperative nausea and vomiting, Intranasal lidocaine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test drug
Arm Type
Experimental
Arm Description
2% Lidocaine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% Normal Saline
Intervention Type
Drug
Intervention Name(s)
2% Lidocaine HCl topical solution
Intervention Description
0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device.
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium chloride
Intervention Description
0.5mL of 0.9% Sodium chloride (normal saline) will be administered intranasally in each nostril with a mucosal atomization device.
Primary Outcome Measure Information:
Title
Incidence
Description
The incidence of nausea and/or vomiting will be measured by asking the nurse and patient.
Time Frame
up to 1 day
Secondary Outcome Measure Information:
Title
Duration of nausea and/or vomiting
Description
Duration of nausea and/or vomiting as measured by patient report and physician/nursing observation. This will take place during PACU phase 1.
Time Frame
up to 1 day
Title
Rescue treatments
Description
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.
Time Frame
up to 1 day
Title
Duration of stay in PACU.
Description
Duration (in hours) in PACU phase 1 will be recorded, this is typically up to 4 hours.
Time Frame
up to 1 day
Title
Patient satisfaction
Description
The patients will be asked to grade their satisfaction level as very satisfied, satisfied, dissatisfied, or very dissatisfied)
Time Frame
At 6 hours after surgery or discharge home, whichever occurs first
Title
Intensity
Description
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.
Time Frame
At 6 hours after surgery or discharge home, whichever occurs first
Title
Severity
Description
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).
Time Frame
up to 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Non-English speaking patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Royo, MD
Organizational Affiliation
Penn State Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28455599
Citation
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Results Reference
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PubMed Identifier
25638733
Citation
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.
Results Reference
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PubMed Identifier
30718165
Citation
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.
Results Reference
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PubMed Identifier
31000893
Citation
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.
Results Reference
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PubMed Identifier
30283168
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
30303542
Citation
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Results Reference
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PubMed Identifier
21061107
Citation
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.
Results Reference
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29864216
Citation
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Citation
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Results Reference
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Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.
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