Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Phase 4

Completed

• Conditions: Nausea and Vomiting, Postoperative
• Interventions: Drug: Placebo; Drug: Ondansetron

• Registration Number: NCT00878228
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-07
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Results First Submitted: 2012-07-23
• Results First Submitted QC: 2012-07-23
• Results First Posted: 2012-08-28
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
Study Group	Ondansetron	The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).

Primary Outcome Measures

Name	Time	Method
Incidence of Nausea	Postdischarge Day 1	Percentage of participants with nausea

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States