Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
NCT ID: NCT03117140
Last Updated: 2018-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2013-12-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Plain Ropivacaine
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%
Only ropivacaine 0.75% is administered for this arm of the interscalene block
Ropivacaine + Buprenorphine
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine
Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
Ropivacaine + Clonidine
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine
Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
Ropivaciane + Dexamethasone
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone
Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
Interventions
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Ropivacaine 0.75%
Only ropivacaine 0.75% is administered for this arm of the interscalene block
Ropivacaine 0.75% + 300 mcg Buprenorphine
Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
Ropivacaine 0.75% + 75 mcg clonidine
Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
Ropivacaine 0.75% + 8 mg dexamethasone
Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Orthopedics service patients having shoulder surgery
2. ASA(American Society of Anesthesiologists) class I, II, or III.
3. Patients at least 18 years old but less than 71 years old.
4. Patients giving informed consent.
5. Non-Emergency Surgery
Exclusion Criteria
1. An inability to cooperate during the block placement.
2. Neuropathy of the planned extremity to block
3. Diabetes
4. Documented Kidney Disease
5. Documented Liver Disease
6. A lack of or inability to give informed consent.
7. Currently incarcerated.
8. Pregnant
18 Years
70 Years
ALL
Yes
Sponsors
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Melinda Seering
OTHER
Responsible Party
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Melinda Seering
Clinical Assistant Profession, Prinicipal Investigator
Principal Investigators
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Melinda Seering, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospital and Clinics, Ambulatory Surgery Clinic
Iowa City, Iowa, United States
Countries
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References
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Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
Yilmaz-Rastoder E, Gold MS, Hough KA, Gebhart GF, Williams BA. Effect of adjuvant drugs on the action of local anesthetics in isolated rat sciatic nerves. Reg Anesth Pain Med. 2012 Jul-Aug;37(4):403-9. doi: 10.1097/AAP.0b013e3182485965.
Ilfeld BM, Morey TE, Enneking FK. Continuous infraclavicular brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002 Jun;96(6):1297-304. doi: 10.1097/00000542-200206000-00006.
Ilfeld BM, Morey TE, Thannikary LJ, Wright TW, Enneking FK. Clonidine added to a continuous interscalene ropivacaine perineural infusion to improve postoperative analgesia: a randomized, double-blind, controlled study. Anesth Analg. 2005 Apr;100(4):1172-1178. doi: 10.1097/01.ASN.0000145571.41015.D5.
Ilfeld BM, Morey TE, Wang RD, Enneking FK. Continuous popliteal sciatic nerve block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002 Oct;97(4):959-65. doi: 10.1097/00000542-200210000-00031.
Ilfeld BM, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Chmielewski TL, Spadoni EH, Wright TW. Ambulatory continuous interscalene nerve blocks decrease the time to discharge readiness after total shoulder arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2006 Nov;105(5):999-1007. doi: 10.1097/00000542-200611000-00022.
White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4.
Capdevila X, Pirat P, Bringuier S, Gaertner E, Singelyn F, Bernard N, Choquet O, Bouaziz H, Bonnet F; French Study Group on Continuous Peripheral Nerve Blocks. Continuous peripheral nerve blocks in hospital wards after orthopedic surgery: a multicenter prospective analysis of the quality of postoperative analgesia and complications in 1,416 patients. Anesthesiology. 2005 Nov;103(5):1035-45. doi: 10.1097/00000542-200511000-00018.
Saporito A, Sturini E, Petri J, Borgeat A, Aguirre JA. Case report: unusual complication during outpatient continuous regional popliteal analgesia. Can J Anaesth. 2012 Oct;59(10):958-62. doi: 10.1007/s12630-012-9758-9. Epub 2012 Jul 25.
Candido KD, Franco CD, Khan MA, Winnie AP, Raja DS. Buprenorphine added to the local anesthetic for brachial plexus block to provide postoperative analgesia in outpatients. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):352-6. doi: 10.1053/rapm.2001.23931.
Candido KD, Winnie AP, Ghaleb AH, Fattouh MW, Franco CD. Buprenorphine added to the local anesthetic for axillary brachial plexus block prolongs postoperative analgesia. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):162-7. doi: 10.1053/rapm.2002.30671.
Candido KD, Hennes J, Gonzalez S, Mikat-Stevens M, Pinzur M, Vasic V, Knezevic NN. Buprenorphine enhances and prolongs the postoperative analgesic effect of bupivacaine in patients receiving infragluteal sciatic nerve block. Anesthesiology. 2010 Dec;113(6):1419-26. doi: 10.1097/ALN.0b013e3181f90ce8.
Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.
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Casati A, Magistris L, Fanelli G, Beccaria P, Cappelleri G, Aldegheri G, Torri G. Small-dose clonidine prolongs postoperative analgesia after sciatic-femoral nerve block with 0.75% ropivacaine for foot surgery. Anesth Analg. 2000 Aug;91(2):388-92. doi: 10.1097/00000539-200008000-00029.
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Duma A, Urbanek B, Sitzwohl C, Kreiger A, Zimpfer M, Kapral S. Clonidine as an adjuvant to local anaesthetic axillary brachial plexus block: a randomized, controlled study. Br J Anaesth. 2005 Jan;94(1):112-6. doi: 10.1093/bja/aei009. Epub 2004 Oct 29.
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Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70.
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Modi M, Rastogi S, Kumar A. Buprenorphine with bupivacaine for intraoral nerve blocks to provide postoperative analgesia in outpatients after minor oral surgery. J Oral Maxillofac Surg. 2009 Dec;67(12):2571-6. doi: 10.1016/j.joms.2009.07.014.
Ip VH, Tsui BC. Practical concepts in the monitoring of injection pressures during peripheral nerve blocks. Int Anesthesiol Clin. 2011 Fall;49(4):67-80. doi: 10.1097/AIA.0b013e31821775bc. No abstract available.
Tsui BC, Li LX, Pillay JJ. Compressed air injection technique to standardize block injection pressures. Can J Anaesth. 2006 Nov;53(11):1098-102. doi: 10.1007/BF03022877.
Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, Bouaziz H, Samii K. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline Service. Anesthesiology. 2002 Nov;97(5):1274-80. doi: 10.1097/00000542-200211000-00034.
Neal JM, Bernards CM, Hadzic A, Hebl JR, Hogan QH, Horlocker TT, Lee LA, Rathmell JP, Sorenson EJ, Suresh S, Wedel DJ. ASRA Practice Advisory on Neurologic Complications in Regional Anesthesia and Pain Medicine. Reg Anesth Pain Med. 2008 Sep-Oct;33(5):404-15. doi: 10.1016/j.rapm.2008.07.527.
Laur JJ, Chehade JM, Merrill DG. Managing neural dysfunction after regional anesthesia: experience in a walk-in follow-up clinic. Int Anesthesiol Clin. 2011 Summer;49(3):44-55. doi: 10.1097/AIA.0b013e318217fe85. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201304727
Identifier Type: -
Identifier Source: org_study_id
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