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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00878228
First received: April 7, 2009
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention Phase
Nausea and Vomiting, Postoperative
Drug: Ondansetron
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Incidence of Nausea [ Time Frame: Postdischarge Day 1 ] [ Designated as safety issue: No ]
    Percentage of participants with nausea


Secondary Outcome Measures:
  • Severity of Nausea [ Time Frame: Postdischarge Day 1 ] [ Designated as safety issue: No ]
    Percentage of participants reporting moderate or severe nausea in the first 24 hours

  • Impact of Nausea and Vomiting on Quality of Life [ Time Frame: Postdischarge Day 1 ] [ Designated as safety issue: No ]
    Percentage of participants whose quality of life was impacted by nausea and vomiting


Enrollment: 98
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group
The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
Drug: Ondansetron
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 Name: Zofran
Placebo Comparator: Control Group
The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
Drug: Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878228

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Jacques YaDeau, MD, PhD Hosptial for Special Surgery
  More Information

Additional Information:
Publications:

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00878228     History of Changes
Other Study ID Numbers: 29015
Study First Received: April 7, 2009
Results First Received: July 23, 2012
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Antiemetics
Ondansetron
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on July 24, 2014