Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy (PDNV)

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Nausea and Vomiting, Postoperative

Treatments: Drug: Ondansetron; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00878228

29015

Details and patient eligibility

About

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).

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups, including a placebo group

Study Group

Experimental group

Description:

The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).

Treatment:

Drug: Ondansetron

Control Group

Placebo Comparator group

Description:

The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).

Treatment:

Drug: Placebo