Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population
NCT ID: NCT04298099
Last Updated: 2024-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
4 participants
INTERVENTIONAL
2020-12-18
2021-03-29
Brief Summary
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Secondary outcomes will assess the efficacy of the block with perioperative morphine equivalent consumption and pain scores.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chest tubes or minimally invasive video assisted thoracic surgery;
* Surgery scheduled between 7AM and 5PM
* Weight greater than 4kg
Exclusion Criteria
* Liver dysfunction;
* Hypoalbuminemia;
* Allergy to local anesthetic;
* Spinal hardware or instrumentation;
* Scoliosis;
* Obesity defined as a BMI \>95% percentile
6 Months
18 Years
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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Karla Elizabeth Wyatt
Assistant Professor
Principal Investigators
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Karla Wyatt, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Texas Children's Hospital
Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Arvidsson T, Eklund E. Determination of free concentration of ropivacaine and bupivacaine in blood plasma by ultrafiltration and coupled-column liquid chromatography. J Chromatogr B Biomed Appl. 1995 Jun 9;668(1):91-8. doi: 10.1016/0378-4347(95)00059-r.
Yasumura R, Kobayashi Y, Ochiai R. A comparison of plasma levobupivacaine concentrations following transversus abdominis plane block and rectus sheath block. Anaesthesia. 2016 May;71(5):544-9. doi: 10.1111/anae.13414. Epub 2016 Mar 4.
Berde CB, Yaster M, Meretoja O, McCann ME, Huledal G, Gustafsson U, Larsson LE. Stable plasma concentrations of unbound ropivacaine during postoperative epidural infusion for 24-72 hours in children. Eur J Anaesthesiol. 2008 May;25(5):410-7. doi: 10.1017/S0265021507003146. Epub 2008 Jan 21.
Tucker GT. Pharmacokinetics of local anaesthetics. Br J Anaesth. 1986 Jul;58(7):717-31. doi: 10.1093/bja/58.7.717. No abstract available.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H-46638
Identifier Type: -
Identifier Source: org_study_id
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