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

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status and phase

Completed
Phase 4

Conditions

Nausea and Vomiting, Postoperative

Treatments

Drug: Ondansetron
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00878228
29015

Details and patient eligibility

About

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).

Enrollment

98 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

98 participants in 2 patient groups, including a placebo group

Study Group
Experimental group
Description:
The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
Treatment:
Drug: Ondansetron
Control Group
Placebo Comparator group
Description:
The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems