Intranasal Lidocaine for Prevention of Postoperative Nausea and Vomiting. A Prospective Double Blind Randomized Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Local anesthetic allergy
- •Liver diseases
- •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
研究组 & 干预措施
test drug
2% Lidocaine
干预措施: 2% Lidocaine HCl topical solution (Drug)
Placebo
0.9% Normal Saline
干预措施: 0.9% Sodium chloride (Drug)
结局指标
主要结局
Incidence
时间窗: up to 1 day
The incidence of nausea and/or vomiting will be measured by asking the nurse and patient.
次要结局
- Duration of stay in PACU.(up to 1 day)
- Severity(up to 1 day)
- Duration of nausea and/or vomiting(up to 1 day)
- Intensity(At 6 hours after surgery or discharge home, whichever occurs first)
- Patient satisfaction(At 6 hours after surgery or discharge home, whichever occurs first)
- Rescue treatments(up to 1 day)
研究者
Marc Royo
Assistant Professor, Department of Anesthesiology and Perioperative Medicine
Milton S. Hershey Medical Center