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

Primary Purpose

Nausea and Vomiting, Postoperative

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ondansetron

Placebo

About this trial

This is an interventional treatment trial for Nausea and Vomiting, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Group

Control Group

Arm Description

The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).

The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).

Outcomes

Primary Outcome Measures

Incidence of Nausea

Percentage of participants with nausea

Secondary Outcome Measures

Severity of Nausea

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

Impact of Nausea and Vomiting on Quality of Life

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

Full Information

NCT ID

NCT00878228

First Posted

April 7, 2009

Last Updated

January 28, 2013

Sponsor

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT00878228

Brief Title

Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Acronym

PDNV

Official Title

Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea and Vomiting, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group

Arm Type

Experimental

Arm Description

The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Other Intervention Name(s)

Zofran

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Outcome Measure Information:

Title

Incidence of Nausea

Description

Percentage of participants with nausea

Time Frame

Postdischarge Day 1

Secondary Outcome Measure Information:

Title

Severity of Nausea

Description

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

Time Frame

Postdischarge Day 1

Title

Impact of Nausea and Vomiting on Quality of Life

Description

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

Time Frame

Postdischarge Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques YaDeau, MD, PhD

Organizational Affiliation

Hosptial for Special Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

9257427

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. doi: 10.1007/s005200050078.

Results Reference

background

PubMed Identifier

18633020

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.

Results Reference

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PubMed Identifier

18042859

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, Tramer 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. doi: 10.1213/01.ane.0000295230.55439.f4.

Results Reference

background

PubMed Identifier

15190136

Citation

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. doi: 10.1056/NEJMoa032196.

Results Reference

background

PubMed Identifier

18633023

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.

Results Reference

background

PubMed Identifier

18633024

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.

Results Reference

background

PubMed Identifier

12198050

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. doi: 10.1097/00000539-200209000-00025.

Results Reference

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Links:

URL

http://www.hss.edu

Description

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

Learn more about this trial

Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

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