Anesthesia, LocalPhase 4NCT04298099

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

A Phase 4 study testing Ropivacaine in people with Anesthesia, Local, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 6 months to 18 years
Conditions the study is for: Anesthesia, Local
What is being tested?: Ropivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 18 Dec 2020to 29 Mar 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age: 6 months - < 18 years old;
Chest tubes or minimally invasive video assisted thoracic surgery;
Surgery scheduled between 7AM and 5PM
Weight greater than 4kg

Who cannot join

Renal dysfunction;
Liver dysfunction;
Hypoalbuminemia;
Allergy to local anesthetic;
Spinal hardware or instrumentation;
Scoliosis;
Obesity defined as a BMI >95% percentile

Trial locations and contacts

1 site in 1 country.

United States1 site

Texas Children's Hospital
Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

This pilot study will enroll patients at Texas Children's Hospital, aged 6 months to <18 years scheduled to undergo a clinically indicated thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. A single shot erector spinae plane block is commonly offered for unilateral video-assisted thoracoscopic surgery (VATS) and unilateral chest tube insertions. Following parental consent and child assent to the block, participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg. This pilot study poses no additional risk to the patient and the thoracic surgical procedures outlined are those for which an erector spinae plane block would be offered. Furthermore, the block dosing of 0.3ml/kg volumes with ropivacaine 0.2% or 0.5% are not outside of the standard of care or accepted dosages for peripheral nerve blocks.

Venous sample serum ropivacaine levels will be collected prior to ESP block and at 30, 60, 90-minutes and 2, 4, 6 -hours from intravenous access in situ. A baseline alpha-1 acid glycoprotein (AGP) test will be collected and processed by TCH Pathology. Amide local anesthetics are predominantly protein bound to AGP. It is the unbound form that is active. While this study seeks to understand the pharmacokinetics of ropivacaine following a single shot erector spinae plane block, correlate of the AGP will simultaneously ascertain the free vs bound portion.

Samples will be analyzed for the total and free serum ropivacaine concentrations. Pain scores will be collected from nursing records starting from arrival in the Post-Anesthesia Care Unit every 4 hours (up to 12 hours after arrival in PACU). Pain will be measured using The Face, Legs, Activity, Cry, Consolability scale (FLACC), the Wong-Baker FACES Pain Rating Scale (FACES), and the Visual Analogue Scale (VAS).

Conditions: Anesthesia, Local
Being tested: Ropivacaine
Keywords: Ropivacaine, Erector spinae plane block, Pediatric

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RopivacaineDrug
Also called Naropin
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.

Study groups in NCT04298099
Study group	Role	What they receive
Ropivacaine 0.2% at 0.3ml/kg	Active comparator	Ropivacaine 0.2% at 0.3ml/kg Receives: Drug: Ropivacaine
Ropivacaine 0.5% at 0.3ml/kg	Active comparator	Ropivacaine 0.5% at 0.3ml/kg Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Post-anesthesia Care Unit Pain Scores Using FLACC Scale
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.
Measured: Every 4 hours (up to 12 hours after arrival in PACU)
Post-anesthesia Care Unit Pain Scores Using FACES Pain Rating 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.
Measured: Every 4 hours (up to 12 hours after arrival in PACU)
Post-anesthesia Care Unit Pain Scores Using VAS
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.
Measured: Every 4 hours (up to 12 hours after arrival in PACU)
Morphine Equivalents
Consumption of morphine per subject was collected post-operatively.
Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 202029 Mar 2021

First posted6 Mar 2020
Study start18 Dec 2020
Primary completion27 Jan 2021
Study completion29 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Participants will be assigned to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg on an odd/even basis
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04298099
Sponsor's protocol ID: H-46638
Status last verified: May 2024
First submitted: 3 Mar 2020
Last updated: 17 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.
PubMed 30074928
Suresh S, De Oliveira GS Jr. Local anaesthetic dosage of peripheral nerve blocks in children: analysis of 40 121 blocks from the Pediatric Regional Anesthesia Network database. Br J Anaesth. 2018 Feb;120(2):317-322. doi: 10.1016/j.bja.2017.10.019. Epub 2017 Nov 24.
PubMed 29406181
Lonnqvist PA, Ecoffey C, Bosenberg A, Suresh S, Ivani G. The European society of regional anesthesia and pain therapy and the American society of regional anesthesia and pain medicine joint committee practice advisory on controversial topics in pediatric regional anesthesia I and II: what do they tell us? Curr Opin Anaesthesiol. 2017 Oct;30(5):613-620. doi: 10.1097/ACO.0000000000000508.
PubMed 28786855
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
PubMed 30621377
Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.
PubMed 30055991
Fang B, Wang Z, Huang X. Ultrasound-guided preoperative single-dose erector spinae plane block provides comparable analgesia to thoracic paravertebral block following thoracotomy: a single center randomized controlled double-blind study. Ann Transl Med. 2019 Apr;7(8):174. doi: 10.21037/atm.2019.03.53.
PubMed 31168455
Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.
PubMed 28447318
Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238.
PubMed 29738328
Suresh S, De Oliveira GS Jr. Blood Bupivacaine Concentrations After Transversus Abdominis Plane Block in Neonates: A Prospective Observational Study. Anesth Analg. 2016 Mar;122(3):814-817. doi: 10.1213/ANE.0000000000001088.
PubMed 26579846
Suresh S, Taylor LJ, De Oliveira GS Jr. Dose effect of local anesthetics on analgesic outcomes for the transversus abdominis plane (TAP) block in children: a randomized, double-blinded, clinical trial. Paediatr Anaesth. 2015 May;25(5):506-10. doi: 10.1111/pan.12550. Epub 2014 Oct 21.
PubMed 25331203
Long JB, Birmingham PK, De Oliveira GS Jr, Schaldenbrand KM, Suresh S. Transversus abdominis plane block in children: a multicenter safety analysis of 1994 cases from the PRAN (Pediatric Regional Anesthesia Network) database. Anesth Analg. 2014 Aug;119(2):395-399. doi: 10.1213/ANE.0000000000000284.
PubMed 24918899
Knudsen K, Beckman Suurkula M, Blomberg S, Sjovall J, Edvardsson N. Central nervous and cardiovascular effects of i.v. infusions of ropivacaine, bupivacaine and placebo in volunteers. Br J Anaesth. 1997 May;78(5):507-14. doi: 10.1093/bja/78.5.507.
PubMed 9175963
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476
Zhang FF, Lv C, Yang LY, Wang SP, Zhang M, Guo XW. Pharmacokinetics of ropivacaine in elderly patients receiving fascia iliaca compartment block. Exp Ther Med. 2019 Oct;18(4):2648-2652. doi: 10.3892/etm.2019.7838. Epub 2019 Aug 1.
PubMed 31572513

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anesthesia, Local trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population
ClinicalTrials.gov ID: NCT04298099
Acronym / sponsor ID: H-46638
Conditions: Anesthesia, Local
Keywords: Ropivacaine, Erector spinae plane block, Pediatric
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: 18 Dec 2020 (actual)
Primary completion: 27 Jan 2021 (actual)
Study completion: 29 Mar 2021 (actual)
First posted: 6 Mar 2020 (actual)
Results: Posted 17 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be assigned to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg on an odd/even basis

Arm	Type	Receives
Ropivacaine 0.2% at 0.3ml/kg	Active comparator	Drug: RopivacaineRopivacaine 0.2% at 0.3ml/kg
Ropivacaine 0.5% at 0.3ml/kg	Active comparator	Drug: RopivacaineRopivacaine 0.5% at 0.3ml/kg

Who may qualify

Ages: 6 months to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Age: 6 months - < 18 years old;
Chest tubes or minimally invasive video assisted thoracic surgery;
Surgery scheduled between 7AM and 5PM
Weight greater than 4kg

Key exclusion criteria (7 listed)

Renal dysfunction;
Liver dysfunction;
Hypoalbuminemia;
Allergy to local anesthetic;
Spinal hardware or instrumentation;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RopivacaineAlso: NaropinGiven 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.	Drug	Ropivacaine 0.2% at 0.3ml/kg, Ropivacaine 0.5% at 0.3ml/kg

Primary outcome

Ropivacaine Concentrations
Time frame: 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.

4 secondary outcomes

Post-anesthesia Care Unit Pain Scores Using FLACC Scale
Time frame: Every 4 hours (up to 12 hours after arrival in PACU)
Post-anesthesia Care Unit Pain Scores Using FACES Pain Rating Scale
Time frame: Every 4 hours (up to 12 hours after arrival in PACU)
Post-anesthesia Care Unit Pain Scores Using VAS
Time frame: Every 4 hours (up to 12 hours after arrival in PACU)
Morphine Equivalents
Time frame: 12 hours

Results and safety

Results posted to the registry on 17 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ropivacaine 0.2% at 0.3ml/kg	0	0
Ropivacaine 0.5% at 0.3ml/kg	4	4

Primary outcome: Ropivacaine Concentrations

Time frame: Prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ. Mean (Standard Deviation). Unit: ng/mL

Measure	Ropivacaine 0.2% at 0.3ml/kg n = 0	Total Ropivacaine Concentration (ng/mL) n = 4	Free Ropivacaine Concentration (ng/mL) n = 4
Time (Baseline/Trough)	–	0 (0)	0 (0)
Time (30min post administration)	–	1232.25 (282.20)	850.25 (187.19)
Time (60 min post administration)	–	776.25 (318.57)	518 (151.33)
Time (90 min post administration)	–	949.5 (100.1)	631 (174.73)
Time (120 min post administration)	–	779.5 (386.24)	468.25 (202.10)
Time (240 min post administration)	–	684 (425.62)	417 (229.83)
Time (360 min post administration)	–	780.5 (336.5)	509 (146)

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Length of surgery plus12 hours post-op. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ropivacaine 0.2% at 0.3ml/kg	0 of 0	0 of 0	0
Ropivacaine 0.5% at 0.3ml/kg	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Alpha Acid Glycoprotein (AAG)	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30074928Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.
Background: PubMed 29406181Suresh S, De Oliveira GS Jr. Local anaesthetic dosage of peripheral nerve blocks in children: analysis of 40 121 blocks from the Pediatric Regional Anesthesia Network database. Br J Anaesth. 2018 Feb;120(2):317-322. doi: 10.1016/j.bja.2017.10.019. Epub 2017 Nov 24.
Background: PubMed 28786855Lonnqvist PA, Ecoffey C, Bosenberg A, Suresh S, Ivani G. The European society of regional anesthesia and pain therapy and the American society of regional anesthesia and pain medicine joint committee practice advisory on controversial topics in pediatric regional anesthesia I and II: what do they tell us? Curr Opin Anaesthesiol. 2017 Oct;30(5):613-620. doi: 10.1097/ACO.0000000000000508.
Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Background: PubMed 30621377De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
Background: PubMed 30055991Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.
Background: PubMed 31168455Fang B, Wang Z, Huang X. Ultrasound-guided preoperative single-dose erector spinae plane block provides comparable analgesia to thoracic paravertebral block following thoracotomy: a single center randomized controlled double-blind study. Ann Transl Med. 2019 Apr;7(8):174. doi: 10.21037/atm.2019.03.53.
Background: PubMed 28447318Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.
Background: PubMed 29738328Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238.
Background: PubMed 26579846Suresh S, De Oliveira GS Jr. Blood Bupivacaine Concentrations After Transversus Abdominis Plane Block in Neonates: A Prospective Observational Study. Anesth Analg. 2016 Mar;122(3):814-817. doi: 10.1213/ANE.0000000000001088.
Background: PubMed 25331203Suresh S, Taylor LJ, De Oliveira GS Jr. Dose effect of local anesthetics on analgesic outcomes for the transversus abdominis plane (TAP) block in children: a randomized, double-blinded, clinical trial. Paediatr Anaesth. 2015 May;25(5):506-10. doi: 10.1111/pan.12550. Epub 2014 Oct 21.
Background: PubMed 24918899Long JB, Birmingham PK, De Oliveira GS Jr, Schaldenbrand KM, Suresh S. Transversus abdominis plane block in children: a multicenter safety analysis of 1994 cases from the PRAN (Pediatric Regional Anesthesia Network) database. Anesth Analg. 2014 Aug;119(2):395-399. doi: 10.1213/ANE.0000000000000284.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karla Wyatt, MD, MS principal investigator

Baylor College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine in people with Anesthesia, Local, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ropivacaine Concentrations (time frame: Prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04298099, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.