Regional Anesthesia Block in Fibula Free Flap Reconstruction
NCT ID: NCT03906838
Last Updated: 2019-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2020-01-01
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Regional Nerve Block
Subjects in the regional anesthesia cohort will have a regional anesthesia block and/or catheter placement administered according to current hospital policies and our established standard of care.
Ropivacaine injection
Regional Anesthesia Nerve Block: Incremental injections up to total of 20 mL of 0.5% ropivacaine is administered.
No Regional Nerve Block
Subjects in the no regional anesthesia cohort will not get pre-operative regional anesthesia, and their surgery and anesthesia will be performed according to normal policies and standard of care in our hospital.
No interventions assigned to this group
Interventions
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Ropivacaine injection
Regional Anesthesia Nerve Block: Incremental injections up to total of 20 mL of 0.5% ropivacaine is administered.
Eligibility Criteria
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Inclusion Criteria
* Subjects undergoing primary or secondary reconstruction
Exclusion Criteria
* Subjects with surgical complications requiring significant alteration of the treatment plan
o Subjects requiring a return to the operating room during admission will be excluded, unless it is for a procedure not related to the original surgery occurring after post op day 3, such as a gastrostomy tube or long term IV access.
* Subjects with true allergies to the study drugs
* Subjects undergoing reconstruction with more than 1 free flap, or with the use of any additional regional flaps
* History of substance dependence or enrollment in a pain management program
* Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin.
* Subjects who do not stay in the hospital for at least 4 days post operatively
* Subjects requiring anticoagulation will not require modifications prior to receiving regional anesthesia.
* Inability to properly place catheter or administer the regional anesthesia
18 Years
100 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Rui Fernandes, MD, DMD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida Health Jacksonville
Jacksonville, Florida, United States
Countries
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References
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Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011 Jun 25;377(9784):2215-25. doi: 10.1016/S0140-6736(11)60245-6.
Werner MU, Soholm L, Rotboll-Nielsen P, Kehlet H. Does an acute pain service improve postoperative outcome? Anesth Analg. 2002 Nov;95(5):1361-72, table of contents. doi: 10.1097/00000539-200211000-00049. No abstract available.
Gwira Baumblatt JA, Wiedeman C, Dunn JR, Schaffner W, Paulozzi LJ, Jones TF. High-risk use by patients prescribed opioids for pain and its role in overdose deaths. JAMA Intern Med. 2014 May;174(5):796-801. doi: 10.1001/jamainternmed.2013.12711.
Gomes T, Mamdani MM, Dhalla IA, Paterson JM, Juurlink DN. Opioid dose and drug-related mortality in patients with nonmalignant pain. Arch Intern Med. 2011 Apr 11;171(7):686-91. doi: 10.1001/archinternmed.2011.117.
Paulozzi LJ, Budnitz DS, Xi Y. Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiol Drug Saf. 2006 Sep;15(9):618-27. doi: 10.1002/pds.1276.
Warner M, Chen LH, Makuc DM. Increase in fatal poisonings involving opioid analgesics in the United States, 1999-2006. NCHS Data Brief. 2009 Sep;(22):1-8.
Talmi YP, Horowitz Z, Pfeffer MR, Stolik-Dollberg OC, Shoshani Y, Peleg M, Kronenberg J. Pain in the neck after neck dissection. Otolaryngol Head Neck Surg. 2000 Sep;123(3):302-6. doi: 10.1067/mhn.2000.104946.
Chen SC, Liao CT, Chang JT. Orofacial pain and predictors in oral squamous cell carcinoma patients receiving treatment. Oral Oncol. 2011 Feb;47(2):131-5. doi: 10.1016/j.oraloncology.2010.11.004. Epub 2010 Dec 13.
Bianchini C, Malago M, Crema L, Aimoni C, Matarazzo T, Bortolazzi S, Ciorba A, Pelucchi S, Pastore A. Post-operative pain management in head and neck cancer patients: predictive factors and efficacy of therapy. Acta Otorhinolaryngol Ital. 2016 Apr;36(2):91-6. doi: 10.14639/0392-100X-499. Epub 2016 Apr 29.
Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.
Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.
Related Links
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PROSPECT website
Other Identifiers
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IRB201900883
Identifier Type: -
Identifier Source: org_study_id
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