Trial · NCT07092566
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) pain intensity scores through 7 days (168 hours) for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | Assess pain intensity (evaluated by NRS) after surgery on the as response to the prompt: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?" The AUC will be derived for each participant from self-reported pain scores and will be summarized by treatment group. Generalized linear models with main effect of treatment will be estimated to test for significant differences in AUC between the arms. |
| Secondary | Estimated difference in Numeric Rating Scale (NRS) pain intensity scores over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | Assess modeled daily pain scores using repeated measures analysis; the primary comparison is the treatment-by-time interaction effect. The NRS is a scale to evaluate pain in response to the prompt "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?" |
| Secondary | Total postsurgical opioid consumption (morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | Total opioid consumption will be calculated for each participant as the sum of all administered opioid doses from Postoperative Day 0 through Day 7. All opioid doses will be converted to morphine equivalent dose (MED) using standard conversion factors. The total MED will be compared between treatment arms . |
| Secondary | Estimated difference in postsurgical opioid consumption (in morphine equivalent dose) over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | Assess modeled daily postsurgical opioid consumption using repeated measures analysis; the primary comparison is the treatment-by-time interaction effect. Daily totals in morphine equivalent dose will be calculated for each participant. |
| Secondary | Total postsurgical non-opioid pain medication consumption (in milligrams) over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | Total milligrams consumed for each for ibuprofen, acetaminophen, and naproxen will be calculated for each participant as the sum of the total milligrams consumed from Post Operative Day 0 trough Post Operative Day 7 and compared between arms. The total milligrams consumed will be compared between treatment arms. |
| Secondary | Estimated difference in postsurgical non-opioid consumption over 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | Assess modeled daily postsurgical non-opioid consumption using repeated measures analysis; the primary comparison is the treatment-by-time interaction effect. Medications informing this analysis include ibuprofen, acetaminophen, and naproxen. Daily totals in milligrams consumed will be calculated for each participant. |
| Secondary | Proportion of opioid-free participants after 7 days for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | The proportion of participants who did not receive any opioid medication from Postoperative Day 0 through Day 7. Participants will be classified as opioid-free if their total opioid consumption during this period is zero (0 mg morphine equivalent dose). The proportion will be compared between treatment arms. |
| Secondary | Time to first opioid intake in hours from surgery for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 7 Post-Surgery | Time to first opioid intake will be defined as the time, in hours, from end of surgery to first opioid medication taken. If participant does not use opioid medication, the time to first opioid intake will be censored at the end of POD7. This will be compared between the arms. |
| Secondary | Length of inpatient stay after surgery for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 30 Post-Surgery | Length of inpatient stay is defined as the total duration, in days (where a full day includes an overnight stay), from the end of surgery until the participant is formally discharged from the hospital. This measure will be used to compare hospitalization duration between treatment arms. |
| Other | Proportion of participants experiencing any study -drug related adverse events within 30 days of surgery for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 30 Post-Surgery | A binary variable indicating experience of at least one AE occurring within 30 days of administration of study drug will be determined for each participant. The proportions will be compared between treatment arms. |
| Other | Proportion of participants experiencing any study -drug related Grade 3+ adverse events within 30 days of surgery for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 30 Post-Surgery | A binary variable indicating experience of at least one Grade 3+ AE occurring within 30 days of administration of study drug will be determined for each participant. The proportions will be compared between treatment arms. |
| Other | Proportion of participants experiencing any serious adverse events within 30 days of surgery for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 30 Post-Surgery | A binary variable indicating experience of at least one SAE occurring within 30 days of administration of study drug will be determined for each participant. The proportions will be compared between treatment arms. |
| Other | Proportion of participants experiencing any surgical complications within 14 days of surgery for participants receiving Exparel vs. R.E.C.K. | Day of Surgery to Day 14 Post-Surgery | A binary variable indicating experience of at least one surgical complication occurring within 14 days of administration of study drug will be determined for each participant. The proportions will be compared between treatment arms. |
| Other | Proportion of participants experiencing post-discharge readmission within 30 days of initial discharge for participants receiving Exparel vs. R.E.C.K. | Day of Discharge to Day 30 Post-Discharge | A binary variable indicating post-discharge readmission within 30 days of initial hospital discharge will be determined for each participant. The proportions will be compared between treatment arms. |
| Other | All-cause mortality within 30 days post-surgery for participants receiving Exparel vs. R.E.C.K. | Day of Discharge to Day 30 Post-Discharge | The proportions of participants alive at 30 days after initial hospital discharge will be compared between treatment arms. |
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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