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Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Information source: Hospital for Special Surgery, New York
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea and Vomiting, Postoperative

Intervention: Ondansetron (Drug); Placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Hospital for Special Surgery, New York

Official(s) and/or principal investigator(s):
Jacques YaDeau, MD, PhD, Principal Investigator, Affiliation: Hosptial for Special Surgery

Overall contact:
Matthew Rade, BA, Phone: 212.774.7022, Email: RadeM@hss.edu

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).

Clinical Details

Official title: Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary outcome is a decreased incidence of nausea on postoperative days 1, 2, and 3.

Secondary outcome:

One secondary outcome in this study includes reduced vomiting.

The secondary outcomes in this study may include reduced incidences of headaches.

One secondary outcome in this study is decreased patient admission for postoperative nausea & vomiting (PONV).

One secondary outcome in this study may include increased patient satisfaction (Quality of Life).

The secondary outcomes in this study may include reduced incidence of pain.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Matthew Rade, BA, Phone: 212.774.7022, Email: RadeM@hss.edu

Hospital for Special Surgery, New York, New York 10021, United States
Additional Information

This is the link to the Hospital for Special Surgery home website.

Related 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.

Starting date: April 2009
Last updated: April 7, 2009

Page last updated: October 19, 2009

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