drugset / Trial / NCT03117140
Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.
Timeline
- Start
- 2013-12
- Primary completion
- 2017-03
- Completion
- 2017-03
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Movafegh A, Razazian M, Hajimaohamadi F, Meysamie A. Dexamethasone added to lidocaine prolongs axillary brachial plexus blockade. Anesth Analg. 2006 Jan;102(1):263-7. doi: 10.1213/01.ane.0000189055.06729.0a.
- Background 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.
- Background Couture DJ, Cuniff HM, Maye JP, Pellegrini J. The addition of clonidine to bupivacaine in combined femoral-sciatic nerve block for anterior cruciate ligament reconstruction. AANA J. 2004 Aug;72(4):273-8.
- Background 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.
- Background Sripada R, Bowens C Jr. Regional anesthesia procedures for shoulder and upper arm surgery upper extremity update--2005 to present. Int Anesthesiol Clin. 2012 Winter;50(1):26-46. doi: 10.1097/AIA.0b013e31821a0284.
- Background Williams BA. Forecast for perineural analgesia procedures for ambulatory surgery of the knee, foot, and ankle: applying patient-centered paradigm shifts. Int Anesthesiol Clin. 2012 Winter;50(1):126-42. doi: 10.1097/AIA.0b013e31821a00d0.
- Background 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.
- Background Ahadian FM, McGreevy K, Schulteis G. Lumbar transforaminal epidural dexamethasone: a prospective, randomized, double-blind, dose-response trial. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):572-8. doi: 10.1097/AAP.0b013e318232e843.
- Background Bonhomme V, Doll A, Dewandre PY, Brichant JF, Ghassempour K, Hans P. Epidural administration of low-dose morphine combined with clonidine for postoperative analgesia after lumbar disc surgery. J Neurosurg Anesthesiol. 2002 Jan;14(1):1-6. doi: 10.1097/00008506-200201000-00001.
- Background Vukovic J, Ramakrishnan P, Milan Z. Does epidural clonidine improve postoperative analgesia in major vascular surgery? Med Glas (Zenica). 2012 Feb;9(1):49-55.
- Background Walker SM, Yaksh TL. Neuraxial analgesia in neonates and infants: a review of clinical and preclinical strategies for the development of safety and efficacy data. Anesth Analg. 2012 Sep;115(3):638-62. doi: 10.1213/ANE.0b013e31826253f2. Epub 2012 Jul 13.
- Background Kawamoto S, Tatsumi K, Kataoka T, Kamikawa T, Yanagida T, Mandai R. [Comparison of intrathecal morphine and buprenorphine for postoperative analgesia in cesarean delivery]. Masui. 2011 Aug;60(8):892-6. Japanese.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 300 ug | — |
| Subject | Clonidine | Other / unclassified | 75 ug | — |
| Subject | Dexamethasone | Small molecule | 8 mg | — |
| Background | Ropivacaine | Other / unclassified | 0.75 % | — |
Indications
No indication recorded.