Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 19 of 19

List	Outcome	Time frame	Description
Primary	Postoperative Opioid Consumption Rate	From end of surgery through 72 hours postoperatively or hospital discharge, whichever occurs first	Total opioid analgesic administration will be converted to morphine milligram equivalents (MME). Opioid consumption will be expressed as MME per hour during the primary postoperative observation window to account for differences in duration of hospitalization. Lower MME/hour indicates lower opioid consumption.
Primary	Cumulative Postoperative Opioid Consumption	From end of surgery through 72 hours postoperatively or hospital discharge, whichever occurs first	Total opioid analgesic administration during the primary postoperative observation window will be converted to cumulative morphine milligram equivalents (MME). Lower cumulative MME indicates lower total opioid exposure.
Secondary	Change in Pain Intensity at Rest	Baseline; Post Anesthesia Care Unit (first lucidity); 6, 12, 24, 48, and 72 hours after surgery; and postoperative Days 7, 14, and 28	Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. For participants unable to reliably self-report because of cognitive impairment, the Pain Assessment in Advanced Dementia (PAINAD) scale may be used. Reporting change from baseline and change from prior timepoint is anticipated. Longitudinal pain scores will be evaluated. Lower scores indicate less pain.
Secondary	Cumulative Opioid Consumption Through Postoperative Day 14	From surgery through postoperative Day 14	All inpatient and reported outpatient opioid use will be converted to morphine milligram equivalents (MME). Cumulative opioid exposure through postoperative Day 14 will be determined. Lower MME indicates lower opioid exposure.
Secondary	Proportion of Participants Remaining Rescue Opioid-Free Through 72 Hours	From end of surgery through 72 hours postoperatively or hospital discharge, whichever occurs first	The percentage of participants who do not require rescue opioid analgesia during the first 72 hours after surgery will be determined
Secondary	Time to First Rescue Opioid Administration	From end of surgery through 72 hours postoperatively or hospital discharge, whichever occurs first	Time from completion of surgery to the first administration of rescue opioid analgesia will be measured in hours. Participants who do not receive rescue opioids during the observation period will not be analyzed for this outcome measure.
Secondary	Hospital Length of Stay	From index hospital admission to discharge, assessed at hospital discharge (anticipated within 7 days of admission)	Hospital length of stay will be calculated as the number of days from hospital admission to hospital discharge.
Secondary	30-Day All-Cause Hospital Readmission	Within 30 days following index hip fracture surgery (postoperative days 0-30)	The percentage of participants experiencing an all-cause hospital readmission within 30 days following hip fracture surgery will be determined.
Secondary	Incidence of Postoperative Delirium	From completion of index hip fracture surgery through hospital discharge (anticipated within 7 days postoperatively).	The proportion of participants with postoperative delirium identified through standard-of-care clinical assessment and documentation during the index hospitalization will be determined.
Secondary	Incidence of Selected Postoperative Opioid-Related Clinical Events	From completion of index hip fracture surgery through hospital discharge (anticipated within 7 days postoperatively).	The proportion of participants experiencing clinically documented respiratory depression, constipation, falls, or acute cognitive impairment during the index hospitalization will be summarized.
Secondary	Incidence of Postoperative Surgical Complications	From surgery through postoperative Day 28	The proportion of participants experiencing clinically documented complications related to hip fracture surgery will be summarized.
Other	Time to First Postoperative Ambulation	From completion of index hip fracture surgery to first documented ambulation, assessed during the index hospitalization (up to 30 days postoperatively)	Time from completion of surgery to the first documented postoperative ambulation will be measured in hours based on clinical and physical-therapy documentation.
Other	Physical Therapy Session Participation	From the first scheduled postoperative physical therapy session through index hospital discharge (up to 30 days postoperatively)	Participation in postoperative physical therapy will be calculated as the proportion of scheduled physical-therapy sessions completed during the index hospitalization.
Other	PROMIS Pain Interference Score	Postoperative Days 14 and 28	Pain-related interference with daily activities and function will be assessed using the PROMIS Pain Interference 8-item short form. Scores will be summarized for the prospective suzetrigine cohort. Higher scores indicate greater pain interference. No data will be available for historical control arm.
Other	Patient Global Assessment of Pain Control	Postoperative Days 3, 7, and 14	Participants will provide a global assessment of their pain control and treatment experience using the protocol-specified Patient Global Assessment. Results will be summarized descriptively for the prospective suzetrigine cohort only. Lower score indicates a positive outcome.
Other	Suzetrigine Treatment Adherence	From first dose through Day 14	Adherence will be assessed from inpatient medication administration records, participant study-drug diaries, and remaining tablet counts. Measures will include doses taken, missed doses, late doses, early discontinuation, and percentage of prescribed doses completed. Reported as number of patients with each measure. Only applicable to the treatment arm.
Other	Opioid Consumption by Perioperative Time Interval	From hospital admission through postoperative Day 28	Opioid administration will be converted to morphine milligram equivalents (MME) and summarized separately for prespecified clinical periods to distinguish preoperative fracture-related analgesic requirements from intraoperative, immediate postoperative, later inpatient, and post-discharge opioid exposure.
Other	Hospital Discharge Disposition	At index hospital discharge (anticipated within 7 days of admission)	The participant's discharge destination will be categorized as home, inpatient rehabilitation, skilled nursing facility, or another healthcare setting.
Other	Ambulatory Status at Hospital Discharge	At index hospital discharge (anticipated within 7 days of admission)	Functional ambulatory status at index hospital discharge will be determined from clinical and physical therapy documentation and categorized according to the participant's ability to ambulate independently, with assistance, or not at all

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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