Nausea and Vomiting, Postoperative
Conditions
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).
Interventions
DRUGOndansetron
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.
DRUGPlacebo
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.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Nausea | Postdischarge Day 1 | Percentage of participants with nausea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Nausea | Postdischarge Day 1 | Percentage of participants reporting moderate or severe nausea in the first 24 hours |
| Impact of Nausea and Vomiting on Quality of Life | Postdischarge Day 1 | Percentage of participants whose quality of life was impacted by nausea and vomiting |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). | 39 |
| Control Group The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). | 37 |
| Total | 76 |
Baseline characteristics
| Characteristic | Study Group | Control Group | Total |
|---|---|---|---|
| Age Continuous | 42 years STANDARD_DEVIATION 14 | 37 years STANDARD_DEVIATION 11 | 39 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 18 Participants | 19 Participants | 37 Participants |
| Sex: Female, Male Male | 21 Participants | 18 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Incidence of Nausea
Percentage of participants with nausea
Time frame: Postdischarge Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group | Incidence of Nausea | 46 percentage of participants |
| Control Group | Incidence of Nausea | 54 percentage of participants |
Secondary
Impact of Nausea and Vomiting on Quality of Life
Percentage of participants whose quality of life was impacted by nausea and vomiting
Time frame: Postdischarge Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group | Impact of Nausea and Vomiting on Quality of Life | 18 percentage of participants |
| Control Group | Impact of Nausea and Vomiting on Quality of Life | 30 percentage of participants |
Secondary
Severity of Nausea
Percentage of participants reporting moderate or severe nausea in the first 24 hours
Time frame: Postdischarge Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group | Severity of Nausea | 23 percentage of participants |
| Control Group | Severity of Nausea | 32 percentage of participants |