Trial Outcomes & Findings for Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population (NCT NCT04298099)

Last Updated: 2024-05-17

Results Overview

Pharmacokinetics(PK) of free and total serum ropivacaine concentrations following erector spinae plane peripheral nerve block administration. Blood samples were drawn at the indicated time points for each subject. Laboratory assays will be completed and resulted for all subject samples collected.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

Prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ

Results posted on

2024-05-17

Participant Flow

Subjects enrolled from the hospital pre-op area. The enrollment period from Dec. 2020 to January 2021. The initial subject was enrolled on Dec. 18, 2020 and the last enrolled on January 27, 2021. All subjects enrolled met the inclusion criteria and were dosed with 0.5% ropivacaine.

No subjects were enrolled into the Ropivicaine 0.2% at 0.3mL/kg arm.

Participant milestones

Participant milestones
Measure	Ropivacaine 0.2% at 0.3ml/kg Ropivacaine 0.2% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Ropivacaine 0.5% at 0.3ml/kg Ropivacaine 0.5% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.
Overall Study STARTED	0	4
Overall Study COMPLETED	0	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ

Population: All participants were given a 0.5% concentration of ropivacaine at 0.3mL/kg. PK blood samples drawn from baseline( prior to administration)up to 6 hours post dose. Serum concentrations was were compared across time points using the non linear mixed-effects modeling(NONREM) approach. Sode/serum concentration simulations was also utilized in analysis. Data will be reported as either mean, standard deviation or median and interquartile range as appropriate.

Outcome measures

Outcome measures
Measure	Ropivacaine 0.2% at 0.3ml/kg Ropivacaine 0.2% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Total Ropivacaine Concentration (ng/mL) n=4 Participants Ropivacaine 0.5% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Free Ropivacaine Concentration (ng/mL) n=4 Participants Ropivacaine 0.5% at 3mL/kg
Ropivacaine Concentrations Time (Baseline/Trough)	—	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0
Ropivacaine Concentrations Time (30min post administration)	—	1232.25 ng/mL Standard Deviation 282.20	850.25 ng/mL Standard Deviation 187.19
Ropivacaine Concentrations Time (60 min post administration)	—	776.25 ng/mL Standard Deviation 318.57	518 ng/mL Standard Deviation 151.33
Ropivacaine Concentrations Time (90 min post administration)	—	949.5 ng/mL Standard Deviation 100.1	631 ng/mL Standard Deviation 174.73
Ropivacaine Concentrations Time (120 min post administration)	—	779.5 ng/mL Standard Deviation 386.24	468.25 ng/mL Standard Deviation 202.10
Ropivacaine Concentrations Time (240 min post administration)	—	684 ng/mL Standard Deviation 425.62	417 ng/mL Standard Deviation 229.83
Ropivacaine Concentrations Time (360 min post administration)	—	780.5 ng/mL Standard Deviation 336.5	509 ng/mL Standard Deviation 146

SECONDARY outcome

Timeframe: Every 4 hours (up to 12 hours after arrival in PACU)

Population: Scale utilized as developmentally age appropriate.

The Face, Legs, Activity, Cry, Consolability Scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. Scores will be tracked from nursing inputs. There scale was utilized for one subject. The measure data was collected \<2 hours post-op.

Outcome measures

Outcome measures
Measure	Ropivacaine 0.2% at 0.3ml/kg n=1 Participants Ropivacaine 0.2% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Total Ropivacaine Concentration (ng/mL) Ropivacaine 0.5% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Free Ropivacaine Concentration (ng/mL) Ropivacaine 0.5% at 3mL/kg
Post-anesthesia Care Unit Pain Scores Using FLACC Scale	0 score on a scale	—	—

SECONDARY outcome

Timeframe: Every 4 hours (up to 12 hours after arrival in PACU)

Population: Subjects pain scores were collected using a different validated pain scale.

The FACES Pain Rating Scale is a tool originally created for children to help them communicate their pain. Now the scale is used around the world with people ages 3 and older. The scale uses 6 faces scored 0-10 with 0 representing no pain. Each facial criteria increases by a score of 2. Scores will be tracked from nursing inputs. There was no data collected for this measure as this scale was not used. Subjects were assessed with a different validated Pain Scale, not data was collected using this scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 4 hours (up to 12 hours after arrival in PACU)

Population: The assessment was used when developmentally age appropriate. This scale was not used in the assessment of one subject, 3 subjects were analyzed.

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." A score of 0 represents no pain and 10 represents the worst the pain could be. Scores will be tracked from nursing inputs.

Outcome measures

Outcome measures
Measure	Ropivacaine 0.2% at 0.3ml/kg n=3 Participants Ropivacaine 0.2% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Total Ropivacaine Concentration (ng/mL) Ropivacaine 0.5% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Free Ropivacaine Concentration (ng/mL) Ropivacaine 0.5% at 3mL/kg
Post-anesthesia Care Unit Pain Scores Using VAS Subj. 1- Numeric Pain score < 2 hours post op	5 score on a scale	—	—
Post-anesthesia Care Unit Pain Scores Using VAS Subj.2- Numeric Pain score < 2 hours post-op	1.68 score on a scale	—	—
Post-anesthesia Care Unit Pain Scores Using VAS Subj. 4- Numeric Pain score < 2 hours post-op	6 score on a scale	—	—

SECONDARY outcome

Timeframe: 12 hours

Population: Morphine milligram equivalents(MME) obtained on each participant that was administered ropivacaine dose. MME obtained post- operatively.

Consumption of morphine per subject was collected post-operatively.

Outcome measures

Outcome measures
Measure	Ropivacaine 0.2% at 0.3ml/kg n=4 Participants Ropivacaine 0.2% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Total Ropivacaine Concentration (ng/mL) Ropivacaine 0.5% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Free Ropivacaine Concentration (ng/mL) Ropivacaine 0.5% at 3mL/kg
Morphine Equivalents Subject 1 - MME	5 mg	—	—
Morphine Equivalents Subject 2- MME	1.68 mg	—	—
Morphine Equivalents Subject 3 - MME	0 mg	—	—
Morphine Equivalents Subject 4 - MME	6 mg	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-op

Population: A sample was not collected for Subject 1

Serum alpha acid glycoprotein levels were analyzed with serum ropivacaine concentrations. No additional samples were collected for AAG levels but laboratory analysis was completed simultaneously with ropivacaine concentrations.

Outcome measures

Outcome measures
Measure	Ropivacaine 0.2% at 0.3ml/kg n=3 Participants Ropivacaine 0.2% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Total Ropivacaine Concentration (ng/mL) Ropivacaine 0.5% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Free Ropivacaine Concentration (ng/mL) Ropivacaine 0.5% at 3mL/kg
Serum Alpha Acid Glycoprotein(AAG) Level Subject 2	65 mg/dL	—	—
Serum Alpha Acid Glycoprotein(AAG) Level Subject 3	47 mg/dL	—	—
Serum Alpha Acid Glycoprotein(AAG) Level Subject 4	71 mg/dL	—	—

Adverse Events

Ropivacaine 0.2% at 0.3ml/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ropivacaine 0.5% at 0.3ml/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alpha Acid Glycoprotein (AAG)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karla Wyatt-Thompson

Baylor College of Medicine

Phone: 8328245800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ropivacaine 0.2% at 0.3ml/kg Ropivacaine 0.2% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Ropivacaine 0.5% at 0.3ml/kg n=4 Participants Ropivacaine 0.5% at 0.3ml/kg Ropivacaine: Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=4 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	—	0 Participants n=4 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	0 Participants	3 Participants n=4 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	0 Participants	1 Participants n=4 Participants	1 Participants n=4 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	—	4 participants n=4 Participants	4 participants n=4 Participants
Weight(kg) weight (subject 1)	—	56.2 kg n=1 Participants • Participant individual weight on day of intervention.	56.2 kg n=1 Participants • Participant individual weight on day of intervention.
Weight(kg) weight (subject 2)	—	22.1 kg n=1 Participants • Participant individual weight on day of intervention.	22.1 kg n=1 Participants • Participant individual weight on day of intervention.
Weight(kg) weight (subject 3)	—	9.6 kg n=1 Participants • Participant individual weight on day of intervention.	9.6 kg n=1 Participants • Participant individual weight on day of intervention.
Weight(kg) weight (subject 4)	—	53.8 kg n=1 Participants • Participant individual weight on day of intervention.	53.8 kg n=1 Participants • Participant individual weight on day of intervention.
Dose ropivacaine 0.5% at 0.3mL/kg Dose (Subj. 1)	—	84.3 ng/mL n=1 Participants • The dose given for each subject was administered as appropriated for weight.	84.3 ng/mL n=1 Participants • The dose given for each subject was administered as appropriated for weight.
Dose ropivacaine 0.5% at 0.3mL/kg Dose (Subj. 2)	—	33.15 ng/mL n=1 Participants • The dose given for each subject was administered as appropriated for weight.	33.15 ng/mL n=1 Participants • The dose given for each subject was administered as appropriated for weight.
Dose ropivacaine 0.5% at 0.3mL/kg Dose (Subj. 3)	—	11.50 ng/mL n=1 Participants • The dose given for each subject was administered as appropriated for weight.	11.50 ng/mL n=1 Participants • The dose given for each subject was administered as appropriated for weight.
Dose ropivacaine 0.5% at 0.3mL/kg Dose (Subj. 4)	—	9.37 ng/mL n=1 Participants • The dose given for each subject was administered as appropriated for weight.	9.37 ng/mL n=1 Participants • The dose given for each subject was administered as appropriated for weight.