Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy - Full Text View

Sponsor:	Hospital for Special Surgery, New York
Information provided by:	Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:	NCT00878228

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 IV

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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

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

Primary Outcome Measures:

The primary outcome is a decreased incidence of nausea on postoperative days 1, 2, and 3. [ Time Frame: Postoperative days 1, 2 and 3. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

One secondary outcome in this study includes reduced vomiting. [ Time Frame: Postoperative day 1, 2 and 3. ] [ Designated as safety issue: No ]
The secondary outcomes in this study may include reduced incidences of headaches. [ Time Frame: Postoperative day 1, 2 and 3. ] [ Designated as safety issue: No ]
One secondary outcome in this study is decreased patient admission for postoperative nausea & vomiting (PONV). [ Time Frame: Postoperative day 1, 2 and 3. ] [ Designated as safety issue: No ]
One secondary outcome in this study may include increased patient satisfaction (Quality of Life). [ Time Frame: Postoperative dat 1, 2 and 3. ] [ Designated as safety issue: No ]
The secondary outcomes in this study may include reduced incidence of pain. [ Time Frame: Postoperative day 1, 2 and 3. ] [ Designated as safety issue: No ]

Enrollment:	76
Study Start Date:	April 2009
Estimated Study Completion Date:	August 2011
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

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:

This is the link to the Hospital for Special Surgery home website. This link exits the ClinicalTrials.gov site

Publications:

Osoba D, Zee B, Warr D, Latreille J, Kaizer L, Pater J. Effect of postchemotherapy nausea and vomiting on health-related quality of life. The Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. Support Care Cancer. 1997 Jul;5(4):307-13.

Pan PH, Lee SC, Harris LC. Antiemetic prophylaxis for postdischarge nausea and vomiting and impact on functional quality of living during recovery in patients with high emetic risks: a prospective, randomized, double-blind comparison of two prophylactic antiemetic regimens. Anesth Analg. 2008 Aug;107(2):429-38.

Gan TJ, Meyer TA, Apfel CC, Chung F, Davis PJ, Habib AS, Hooper VD, Kovac AL, Kranke P, Myles P, Philip BK, Samsa G, Sessler DI, Temo J, Tramèr MR, Vander Kolk C, Watcha M; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2007 Dec;105(6):1615-28, table of contents.

Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51.

White PF, O'Hara JF, Roberson CR, Wender RH, Candiotti KA; POST-OP Study Group. The impact of current antiemetic practices on patient outcomes: a prospective study on high-risk patients. Anesth Analg. 2008 Aug;107(2):452-8.

White PF, Sacan O, Nuangchamnong N, Sun T, Eng MR. The relationship between patient risk factors and early versus late postoperative emetic symptoms. Anesth Analg. 2008 Aug;107(2):459-63.

Pavlin DJ, Chen C, Penaloza DA, Polissar NL, Buckley FP. Pain as a factor complicating recovery and discharge after ambulatory surgery. Anesth Analg. 2002 Sep;95(3):627-34, table of contents.

Responsible Party:	Jacques YaDeau, MD PhD/Assistant Attending Anesthesiologist, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:	NCT00878228 History of Changes
Other Study ID Numbers:	IRB #29015
Study First Received:	April 7, 2009
Last Updated:	June 24, 2011
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 February 09, 2012