Registered outcomes18

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

1 to 18 of 18

List	Outcome	Time frame	Description
Primary	Adverse events	30 days	Possibly related to bupivacaine toxicity
Primary	Blood pressure (systolic/diastolic)	Starting at Time 0 and continuing for 3 hours and then 5, 8, 12, 24, 36, and 48 hours after Time 0	Signs/symptoms of bupivacaine toxicity
Primary	Heart rate	Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0	Signs/symptoms of bupivacaine toxicity
Primary	Respiratory rate	Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0	Signs/symptoms of bupivacaine toxicity
Primary	Body temperature	Through Day 30	Signs/symptoms of bupivacaine toxicity
Primary	12-lead ECG	1 day at screening	Screening only
Primary	3-lead ECG	Starting at Time 0 and continuing for at least 3 hours	Signs/symptoms of bupivacaine toxicity
Primary	Oxygen saturation levels	Starting at Time 0 and continuing for at least 3 hours	Pulse oximetry
Primary	Clinical laboratory testing	1 day at screening	Collection of blood and urine samples
Primary	Wound healing assessments	Assessment on Day 1 through Day 3; follow-up evaluations on Days 7, 15 and 30	Inspection of surgical wound site for signs of wound infection and dehiscence.
Primary	Nausea	1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0	Measured using a categorical scoring system (none = 0, mild = 1, moderate = 2, and severe = 3). Nausea scores will also be recorded immediately before the use of rescue antiemetics
Primary	Sedation	1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0	Sedation scores: awake and alert = 0, quietly awake = 1, asleep but easily roused = 2, and deep sleep = 3.
Secondary	Cmax	0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0.	Maximum observed plasma concentration
Secondary	AUC0-last	0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0	Area under the plasma concentration time curve from Time zero to last quantifiable plasma concentration
Secondary	AUC0-∞	0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0	Area under the plasma concentration time curve from Time zero to extrapolated through infinity
Secondary	Tmax	0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0	Time to maximum obserbved plasma concentration
Secondary	t1/2	0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0	Apparent first-order terminal elimination half-life
Secondary	Pain intensity	1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0	Assessed using an 11-point NRS (for children 12 to \<17 years of age), a FACES pain severity scale (children 4 through \<12 years of age), or FLACC (children 2 and 3 years of age) immediately before the child receives any parenteral or oral rescue medication for breakthrough pain

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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