NCT04298099

Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population

Completed Phase 4 Results posted Last updated 17 May 2024

What this trial tests

Phase 4 trial testing Ropivacaine in Anesthesia, Local in 4 participants. Completed in 29 March 2021.

Timeline

18 December 2020

Primary endpoint
27 January 2021

29 March 2021

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	4
Start date	18 December 2020
Primary completion	27 January 2021
Estimated completion	29 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Ropivacaine (ROPIVACAINE) — full drug profile →

Conditions studied

• Anesthesia, Local — all drugs for Anesthesia, Local →

Sponsor

Baylor College of Medicine

Who can join

Adults 6 Months to 18, any sex, with Anesthesia, Local. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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.

Time (Baseline/Trough)

Group	Value	95% CI
Total Ropivacaine Concentration (ng/mL)	0	± 0
Free Ropivacaine Concentration (ng/mL)	0	± 0

Time (30min post administration)

Group	Value	95% CI
Total Ropivacaine Concentration (ng/mL)	1232.25	± 282.20
Free Ropivacaine Concentration (ng/mL)	850.25	± 187.19

Time (60 min post administration)

Group	Value	95% CI
Total Ropivacaine Concentration (ng/mL)	776.25	± 318.57
Free Ropivacaine Concentration (ng/mL)	518	± 151.33

Time (90 min post administration)

Group	Value	95% CI
Total Ropivacaine Concentration (ng/mL)	949.5	± 100.1
Free Ropivacaine Concentration (ng/mL)	631	± 174.73

Time (120 min post administration)

Group	Value	95% CI
Total Ropivacaine Concentration (ng/mL)	779.5	± 386.24
Free Ropivacaine Concentration (ng/mL)	468.25	± 202.10

Time (240 min post administration)

Group	Value	95% CI
Total Ropivacaine Concentration (ng/mL)	684	± 425.62
Free Ropivacaine Concentration (ng/mL)	417	± 229.83

Time (360 min post administration)

Group	Value	95% CI
Total Ropivacaine Concentration (ng/mL)	780.5	± 336.5
Free Ropivacaine Concentration (ng/mL)	509	± 146

Post-anesthesia Care Unit Pain Scores Using FLACC Scale Secondary · Every 4 hours (up to 12 hours after arrival in PACU)

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.

Group	Value	95% CI
Post Anesthesia Care Unit (PACU) Pain Scores Using FLACC Scale	0

Post-anesthesia Care Unit Pain Scores Using VAS Secondary · Every 4 hours (up to 12 hours after arrival in PACU)

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.

Subj. 1- Numeric Pain score < 2 hours post op

Group	Value	95% CI
Post Anesthesia Care Unit Pain Scores Using VAS	5

Subj.2- Numeric Pain score < 2 hours post-op

Group	Value	95% CI
Post Anesthesia Care Unit Pain Scores Using VAS	1.68

Subj. 4- Numeric Pain score < 2 hours post-op

Group	Value	95% CI
Post Anesthesia Care Unit Pain Scores Using VAS	6

Morphine Equivalents Secondary · 12 hours

Consumption of morphine per subject was collected post-operatively.

Subject 1 - MME

Group	Value	95% CI
Morphine Equivalents	5

Subject 2- MME

Group	Value	95% CI
Morphine Equivalents	1.68

Subject 3 - MME

Group	Value	95% CI
Morphine Equivalents	0

Subject 4 - MME

Group	Value	95% CI
Morphine Equivalents	6

Serum Alpha Acid Glycoprotein(AAG) Level Secondary · Pre-op

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.

Subject 2

Group	Value	95% CI
Alpha Acid Glycoprotein	65

Subject 3

Group	Value	95% CI
Alpha Acid Glycoprotein	47

Subject 4

Group	Value	95% CI
Alpha Acid Glycoprotein	71

Sponsor's own description

The primary aim of this study is to evaluate the pharmacokinetics of serum ropivacaine concentrations following erector spinae plane peripheral nerve blocks in the pediatric population.

Secondary outcomes will assess the efficacy of the block with perioperative morphine equivalent consumption and pain scores.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.