Postoperative Nausea and Vomiting
Conditions
Keywords
Postoperative nausea and vomiting, Intranasal lidocaine
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.
Interventions
DRUG2% Lidocaine HCl topical solution
0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device.
DRUG0.9% Sodium chloride
0.5mL of 0.9% Sodium chloride (normal saline) will be administered intranasally in each nostril with a mucosal atomization device.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence | up to 1 day | The incidence of nausea and/or vomiting will be measured by asking the nurse and patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue treatments | 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. |
| Duration of stay in PACU. | up to 1 day | Duration (in hours) in PACU phase 1 will be recorded, this is typically up to 4 hours. |
| Duration of nausea and/or vomiting | 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. |
| Intensity | 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. |
| Severity | 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). |
| Patient satisfaction | 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) |
Countries
United States
Outcome results
None listed