Postoperative Nausea and VomitingPhase 4NCT04810494
Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting.
A Phase 4 study testing 2% Lidocaine HCl topical solution and 0.9% Sodium chloride in people with Postoperative Nausea and Vomiting, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- 2% Lidocaine HCl topical solution and 0.9% Sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 30 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- 2% Lidocaine HCl topical solution, 0.9% Sodium chloride
- Keywords
- Postoperative nausea and vomiting, Intranasal lidocaine
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Lidocaine HCl topical solutionDrug
0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device.
0.9% Sodium chlorideDrug
0.5mL of 0.9% Sodium chloride (normal saline) will be administered intranasally in each nostril with a mucosal atomization device.
| Study group | Role | What they receive |
|---|---|---|
| test drug | Experimental | 2% Lidocaine Receives: Drug: 2% Lidocaine HCl topical solution |
| Placebo | Placebo comparator | 0.9% Normal Saline Receives: Drug: 0.9% Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
The incidence of nausea and/or vomiting will be measured by asking the nurse and patient.
Measured: up to 1 day
Secondary outcomes (6)
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.
Measured: up to 1 day
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.
Measured: up to 1 day
Duration of stay in PACU.
Duration (in hours) in PACU phase 1 will be recorded, this is typically up to 4 hours.
Measured: up to 1 day
Patient satisfaction
The patients will be asked to grade their satisfaction level as very satisfied, satisfied, dissatisfied, or very dissatisfied)
Measured: At 6 hours after surgery or discharge home, whichever occurs first
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.
Measured: At 6 hours after surgery or discharge home, whichever occurs first
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).
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Oct 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Why it stopped: Change in study team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Royo, Milton S. Hershey Medical Center
- Investigators
- Marc Royo, MD, Principal investigator, Penn State Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810494
- Sponsor's protocol ID
- STUDY00016664
- Status last verified
- Dec 2022
- First submitted
- 14 Mar 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 28455599Obrink 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.
PubMed 25638733Tabrizi 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.
PubMed 30718165Jeyabalan 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.
PubMed 31000893Tahir 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.
PubMed 30283168Habib 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.
PubMed 16846542Masic 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.
PubMed 30303542Vigneault 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.
PubMed 21061107Weibel 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.
PubMed 29864216Weibel 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.
PubMed 27199310Wengritzky 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.
PubMed 20037151Eberhart 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.
PubMed 10958095
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting. A Prospective Double Blind Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04810494
- Acronym / sponsor ID
- STUDY00016664
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative nausea and vomiting, Intranasal lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in study team
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test drug | Experimental | Drug: 2% Lidocaine HCl topical solution2% Lidocaine |
| Placebo | Placebo comparator | Drug: 0.9% Sodium chloride0.9% Normal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- Local anesthetic allergy
- Liver diseases
- Pregnancy
- Current tobacco use
- Pre-existing disorders of the gastrointestinal tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Lidocaine HCl topical solution0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device. | Drug | test drug |
| 0.9% Sodium chloride0.5mL of 0.9% Sodium chloride (normal saline) will be administered intranasally in each nostril with a mucosal atomization device. | Drug | Placebo |
Primary outcome
Incidence
Time frame: up to 1 day
The incidence of nausea and/or vomiting will be measured by asking the nurse and patient.
6 secondary outcomes
Duration of nausea and/or vomiting
Time frame: up to 1 day
Rescue treatments
Time frame: up to 1 day
Duration of stay in PACU.
Time frame: up to 1 day
Patient satisfaction
Time frame: 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
Severity
Time frame: up to 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 28455599Cao 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.
- Background: PubMed 25638733Obrink 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.
- Background: PubMed 30718165Tabrizi 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.
- Background: PubMed 31000893Jeyabalan 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.
- Background: PubMed 30283168Tahir 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.
- Background: PubMed 16846542Habib 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.
- Background: PubMed 30303542Masic 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.
- Background: PubMed 21061107Vigneault 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.
- Background: PubMed 29864216Weibel 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.
- Background: PubMed 27199310Weibel 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.
- Background: PubMed 20037151Wengritzky 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.
- Background: PubMed 10958095Eberhart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Royo, MD principal investigator
Penn State Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2% Lidocaine HCl topical solution and 0.9% Sodium chloride in people with Postoperative Nausea and Vomiting, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810494, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.