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Completed

NCT Number: NCT00878228

Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

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).

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Key information

Conditions

Nausea and Vomiting, Postoperative Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron

Drug

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.

Other names: Zofran

Placebo

Drug

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.

Primary outcomes

  1. Incidence of Nausea

    Time frame: Postdischarge Day 1

    Percentage of participants with nausea

Secondary outcomes

  1. Severity of Nausea

    Time frame: Postdischarge Day 1

    Percentage of participants reporting moderate or severe nausea in the first 24 hours

  2. Impact of Nausea and Vomiting on Quality of Life

    Time frame: Postdischarge Day 1

    Percentage of participants whose quality of life was impacted by nausea and vomiting

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Acronym: PDNV

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 8, 2009
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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