Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Nausea and Vomiting, Postoperative Clinical Trial

— PDNV  

Official title:

Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878228
• Other study ID #: 29015
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2009
• Last updated: January 28, 2013
• Start date: April 2009
• Est. completion date: February 2010

Study information

• Verified date: January 2013
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1213/ane.0b013e318172f992. — View Citation

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. — View Citation

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. doi: 10.1213/ane.0b013e31817b842c. — View Citation

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. doi: 10.1213/ane.0b013e31817aa6e4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Nausea	Percentage of participants with nausea	Postdischarge Day 1	No
Secondary	Severity of Nausea	Percentage of participants reporting moderate or severe nausea in the first 24 hours	Postdischarge Day 1	No
Secondary	Impact of Nausea and Vomiting on Quality of Life	Percentage of participants whose quality of life was impacted by nausea and vomiting	Postdischarge Day 1	No

External Links

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