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Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery.
The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interscalene Block | Active Comparator | Patients randomized to receive an intesrcalene block. |
|
| Costoclavicular Infraclavicular Block | Experimental | Patients randomized to receive a costoclavicular infraclavicular block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interscalene Block | Procedure | Injection with ultrasound guidance of 20mL of levobupivacaine 0.5% with 5 micrograms of epinephrine per mL in the interscalene groove of the brachial plexus. |
| Measure | Description | Time Frame |
|---|---|---|
| Static pain at 30 minutes after arrival in the PACU | Evaluated with a NRS from 0 to 10 | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Static pain at 60 minutes after arrival in the PACU | Evaluated with a NRS from 0 to 10 | 60 minutes |
| Postoperative static pain at 2 hours | Evaluated with a NRS from 0 to 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universidad de Chile | Santiago | Santiago Metropolitan | 8380456 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19282714 | Background | Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb. | |
| 2006740 | Background | Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020069 | Shoulder Pain |
| D012133 | Respiratory Paralysis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Costoclavicular Infraclavicular Block | Procedure | Ultrasound guided brachial plexus block injecting 20mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in between the cords of the brachial plexus at the costoclavicular infraclavicular space. |
|
| 2 hours |
| Postoperative static pain at 3 hours | Evaluated with a NRS from 0 to 10 | 3 hours |
| Postoperative static pain at 6 hours | Evaluated with a NRS from 0 to 10 | 6 hours |
| Postoperative static pain at 12 hours | Evaluated with a NRS from 0 to 10 | 12 hours |
| Postoperative static pain at 24 hours | Evaluated with a NRS from 0 to 10 | 24 hours |
| Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block | Ultrasound diagnosed HDP | 30 minutes post injection |
| Incidence of HDP at 30 minutes after arrival to PACU | Ultrasound diagnosed HDP | 30 minutes after arrival to the PACU |
| Block performance time | Time from skin disinfection until the end of local anesthetic injection | 1 hour before surgery |
| Sensory and Motor block score | Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score | 30 minutes post injection |
| Incidence of complete block | Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection | 30 minutes post injection |
| Procedural pain during blocks | Evaluated with a NRS from 0 to 10 | 1 hour before surgery |
| Onset time | Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points | 1 hour before surgery |
| Intraoperative opioid requirements | Total amount of fentanyl required during general anesthesia | Intraoperative period |
| Surgical duration | Time between skin incision and closure | Intraoperative period |
| Postoperative opioid consumption | Total amount of morphine required during the first 24 hours after surgery | 24 hours after surgery |
| Patient satisfaction | Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied) | 24 hours after surgery |
| Block- and opioid-related side effects | Incidence of side effects | 1 week |
| 12606927 | Background | Martinez J, Sala-Blanch X, Ramos I, Gomar C. Combined infraclavicular plexus block with suprascapular nerve block for humeral head surgery in a patient with respiratory failure: an alternative approach. Anesthesiology. 2003 Mar;98(3):784-5. doi: 10.1097/00000542-200303000-00031. No abstract available. |
| 29270914 | Background | Aliste J, Bravo D, Finlayson RJ, Tran DQ. A randomized comparison between interscalene and combined infraclavicular-suprascapular blocks for arthroscopic shoulder surgery. Can J Anaesth. 2018 Mar;65(3):280-287. doi: 10.1007/s12630-017-1048-0. Epub 2017 Dec 19. |
| 28205117 | Background | Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15. |
| 16331304 | Background | Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6. |
| 20975470 | Background | Tran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):539-43. doi: 10.1097/AAP.0b013e3181faa11c. |
| 25899958 | Background | Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available. |
| 21568985 | Background | Spence BC, Beach ML, Gallagher JD, Sites BD. Ultrasound-guided interscalene blocks: understanding where to inject the local anaesthetic. Anaesthesia. 2011 Jun;66(6):509-14. doi: 10.1111/j.1365-2044.2011.06712.x. |
| 27396247 | Background | Flohr-Madsen S, Ytrebo LM, Valen K, Wilsgaard T, Klaastad O. A randomised placebo-controlled trial examining the effect on hand supination after the addition of a suprascapular nerve block to infraclavicular brachial plexus blockade. Anaesthesia. 2016 Aug;71(8):938-47. doi: 10.1111/anae.13504. |
| 19535272 | Background | Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16. |
| 30635497 | Derived | Aliste J, Bravo D, Layera S, Fernandez D, Jara A, Maccioni C, Infante C, Finlayson RJ, Tran DQ. Randomized comparison between interscalene and costoclavicular blocks for arthroscopic shoulder surgery. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100055. doi: 10.1136/rapm-2018-100055. Online ahead of print. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010243 | Paralysis |
| D009422 | Nervous System Diseases |