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Local Anesthetic

Ropivacaine 0.2% at 0.3ml/kg for Local Anesthesia

Phase 4

Recruiting

Led By Karla Wyatt, MD, MS

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will test how well a nerve block works in children, measuring things like pain scores and how much morphine they need.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ropivacaine Concentrations

Secondary outcome measures

Morphine Equivalents

Post-anesthesia Care Unit Pain Scores using FACES Pain Rating Scale

Post-anesthesia Care Unit Pain Scores using FLACC Scale

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Ropivacaine 0.2% at 0.3ml/kgActive Control1 Intervention

Ropivacaine 0.2% at 0.3ml/kg

Group II: Ropivacaine 0.5% at 0.3ml/kgActive Control1 Intervention

Ropivacaine 0.5% at 0.3ml/kg

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,188 Total Patients Enrolled

Karla Wyatt, MD, MSPrincipal InvestigatorBaylor College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age cap for this trial higher than 50 years?

"This study requires participants aged 6 Months to 18 years. Furthermore, the trial is recruiting a total of 21 minors and 85 seniors."

Answered by AI

To what conditions is Ropivacaine 0.5% at 0.3ml/kg typically administered?

"Ropivacaine 0.5% at 0.3ml/kg is frequently used for anesthesia procedures and additionally can be utilised to address surgical anaesthesia, labour pains, and postoperative agony."

Answered by AI

Does the US Food and Drug Administration endorse Ropivacaine 0.5% at 0.3ml/kg for therapeutic use?

"Our team has assigned Ropivacaine 0.5% at 0.3ml/kg a safety rating of 3, as this treatment is approved and currently in its fourth phase of clinical trials."

Answered by AI

Is my eligibility suitable for enrollment in this study?

"To qualify for this research study, participants must be between 6 months and 18 years of age with an established history of anesthesia. In total, 24 patients are being accepted into the trial."

Answered by AI

How many individuals have been included in this clinical trial thus far?

"Affirmative. The listing on clinicaltrials.gov outlines that this medical study, which was first submitted on December 17th 2020, is presently recruiting patients for participation. 24 individuals need to be enlisted from one particular location."

Answered by AI

Is the current enrollment period still open for this experiment?

"Affirmative, the data hosted on clinicaltrials.gov confirms that this medical study is actively seeking participants. The trial was initially posted in December 2020 and has been recently updated at the end of February 2022 to accept 24 patients from one particular site."

Answered by AI

Recent research and studies

Current Opinion in AnaesthesiologyJournal

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

Lönnqvist, Per-Arne, Claude Ecoffey, Adrian Bosenberg, Santhanam Suresh, and Giorgio Ivani. 2017. “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”. Current Opinion in Anaesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aco.0000000000000508.

Journal of Cardiothoracic and Vascular AnesthesiaJournal

Bilateral Erector Spinae Plane Block for Acute Post-surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial

Krishna, Siva N., Sandeep Chauhan, Debesh Bhoi, Brajesh Kaushal, Suruchi Hasija, Tsering Sangdup, and Akshay K Bisoi. 2019. “Bilateral Erector Spinae Plane Block for Acute Post-surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1053/j.jvca.2018.05.050.

Canadian Journal of Anesthesia/Journal canadien d'anesthésieJournal

Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Oncological Thoracic Surgery

Muñoz, Felipe, Javier Cubillos, Antonio J. Bonilla, and Ki Jinn Chin. 2017. “Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Oncological Thoracic Surgery”. Canadian Journal of Anesthesia/journal Canadien D'anesthésie. Springer Science and Business Media LLC. doi:10.1007/s12630-017-0894-0.

Journal of Biomedical InformaticsJournal