Trial · NCT03040011
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS) | 24 hours postoperatively | Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain. |
| Secondary | 6 Hour Postoperative Pain Measured by the NRS | 6 hours postoperatively | Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain. Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section. |
| Secondary | POD 2 Postoperative Pain Measured by the NRS | 2 days after surgery | Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain. |
| Secondary | POD 3 Postoperative Pain Measured by the NRS | 3 days after surgery | Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain. |
| Secondary | 1 Week Postoperative Pain Measured by the NRS | 1 week after surgery | Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain. |
| Secondary | Proportion of Patients With Same Day Discharge | Day of surgery | Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups. |
| Secondary | Postoperative Urinary Retention | 0-24 hours postoperatively | Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups. |
| Secondary | Adverse Events | 0-12 weeks postoperatively | The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively. |
| Secondary | Nausea and Vomiting Measured by the PONV Scale | 6 hours postoperatively | Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting. |
| Secondary | Anti-emetic Consumption | 3 hours postoperatively | The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication |
| Secondary | Return to Baseline Activities Using the Activities Assessment Scale | 1 week postoperative | Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint. |
| Secondary | Return to Baseline Activities Using the Activities Assessment Scale | 2 week postoperative | Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint. |
| Secondary | Return to Baseline Activities Using the Activities Assessment Scale | 6 weeks postoperative | Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint. |
| Secondary | Return to Baseline Activities Using the Activities Assessment Scale | 12 weeks postoperative | Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities. We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint. |
| Secondary | POD 1 Narcotic Consumption | Postoperative day 1 | The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents. |
| Secondary | POD 2 Narcotic Consumption | Postoperative day 2 | The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents. |
| Secondary | POD 3 Narcotic Consumption | Postoperative day 3 | The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents. |
| Secondary | POD 1 Ibuprofen Consumption | Postoperative day 1 | The total amount of ibuprofen medication used on postoperative day 1. |
| Secondary | POD 2 Ibuprofen Consumption | Postoperative day 2 | The total amount of ibuprofen medication used on postoperative day 2. |
| Secondary | POD 3 Ibuprofen Consumption | Postoperative day 3 | The total amount of ibuprofen medication used on postoperative day 3. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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