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

NCT04298099 | Completed Phase 4 Results FDA Drug

• 1 other identifier: H-46638
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local

Keywords

Ropivacaine; Erector spinae plane block; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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.

  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

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

• Post-anesthesia Care Unit Pain Scores Using FACES Pain Rating Scale

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

• Post-anesthesia Care Unit Pain Scores Using VAS

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

• Morphine Equivalents

  12 hours

Other Outcomes (1)

• Serum Alpha Acid Glycoprotein(AAG) Level

  Pre-op

Study Arms (2)

Ropivacaine 0.2% at 0.3ml/kg

ACTIVE COMPARATOR

Ropivacaine 0.2% at 0.3ml/kg

Drug: Ropivacaine

Ropivacaine 0.5% at 0.3ml/kg

ACTIVE COMPARATOR

Ropivacaine 0.5% at 0.3ml/kg

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

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.

Also known as: Naropin

Ropivacaine 0.2% at 0.3ml/kg; Ropivacaine 0.5% at 0.3ml/kg

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (20)

• 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.

  PMID: 30074928 BACKGROUND

• 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.

  PMID: 29406181 BACKGROUND

• 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.

  PMID: 28786855 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 30621377 BACKGROUND

• 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.

  PMID: 30055991 BACKGROUND

• 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.

  PMID: 31168455 BACKGROUND

• 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.

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  PMID: 29738328 BACKGROUND

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MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Karla Wyatt-Thompson
• Organization: Baylor College of Medicine

karla.wyatt@bcm.edu

8328245800

Study Officials

• Karla Wyatt, MD, MS

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 6, 2020
• Study Start: December 18, 2020
• Primary Completion: January 27, 2021
• Study Completion: March 29, 2021
• Last Updated: May 17, 2024
• Results First Posted: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)