Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Study Overview
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Brief Summary
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The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron (Zofran) administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post-operative period. These individuals will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (Zofran).

Official Title
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Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Conditions
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Nausea and Vomiting, Postoperative

Intervention / Treatment
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* Drug: Ondansetron
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients of Dr. Coleman or Dr. Kelly ages 18 to 65 undergoing arthroscopic hip surgery Planned use of neuraxial anesthesia Ability to follow study protocol Willing to complete daily diary and be interviewed daily for three days after discharge Exclusion Criteria: Patients younger than 18 years old and older than 65 Patients unable to undergo a spinal or epidural anesthetic Having nausea or vomiting within 24 hours of the surgery Receiving drugs with anti-emetic properties within 24 hours of the surgery (e.g Zofran, Compazine, Phenergan, Reglan) Chronic opioid use (defined as daily or almost daily use of opioids for >3 months) Hypersensitivity and/or allergy to ondansetron Intraoperative use of any volatile anesthetic Contraindication to a short course of NSAIDs (renal failure, intolerance) Allergy or intolerance to Vicodin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). | Drug: Ondansetron<br>* The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos.<br>* Other names: Zofran;|
| Placebo Comparator: Control Group<br>The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). | Drug: Placebo<br>* The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Nausea | Percentage of participants with nausea | Postdischarge Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Nausea | Percentage of participants reporting moderate or severe nausea in the first 24 hours | Postdischarge Day 1 | 
| Impact of Nausea and Vomiting on Quality of Life | Percentage of participants whose quality of life was impacted by nausea and vomiting | Postdischarge Day 1 |