drugset / Trial / NCT04298099
Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population
Non-randomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2020-12-18
- Primary completion
- 2021-01-27
- Completion
- 2021-03-29
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ropivacaine | Other / unclassified | 0.2 % | Other |
| Comparator | Ropivacaine | Other / unclassified | 0.5 % | Other |
Indications
No indication recorded.