Clinical trial NCT03224884: Interscalene Block Versus Supraclavicular Block for Shoulder Surgery
Official title: A Randomized Comparison Between Interscalene and Supraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Shoulder Pain
Surgical Procedure, Unspecified
Diaphragmatic Paralysis
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 will compare ultrasound-guided interscalene block (ISB) and supraclavicular block 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 supraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points


Eligibility criteria: Inclusion Criteria:

* Patients undergoing arthroscopic shoulder surgery
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy
* Coagulopathy
* Obstructive or restrictive pulmonary disease
* Renal failure
* Hepatic failure
* Allergy to local anesthetics
* Pregnancy
* Prior surgery in the corresponding side of the neck or supraclavicular fossa
* Chronic pain syndromes requiring opioid intake at home

Primary outcomes:
measure: Static pain at 30 minutes after arrival in the PACU
timeFrame: 30 minutes
Secondary outcomes:
measure: Static pain at 60 minutes after arrival in the PACU
timeFrame: 60 minutes
measure: Postoperative static pain at 2 hours
timeFrame: 2 hours
measure: Postoperative static pain at 3 hours
timeFrame: 3 hours
measure: Postoperative static pain at 6 hours
timeFrame: 6 hours
measure: Postoperative static pain at 12 hours
timeFrame: 12 hours
measure: Postoperative static pain at 24 hours
timeFrame: 24 hours
measure: Incidence of HDP at 30 minutes after interscalene or supraclavicular block
timeFrame: 30 minutes post injection
measure: Incidence of HDP at 30 minutes after arrival to PACU.
timeFrame: 30 minutes after arrival to PACU
measure: Block performance time
timeFrame: 1 hour before surgery
measure: Sensory and Motor block
timeFrame: 30 minutes post injection
measure: Incidence of complete block
timeFrame: 30 minutes post injection
measure: Procedural pain during blocks
timeFrame: 1 hour before surgery
measure: Onset time
timeFrame: 1 hour before surgery
measure: Intraoperative opioid requirements
timeFrame: Intraoperative period
measure: Surgical duration
timeFrame: intraoperative period
measure: Postoperative opioid consumption
timeFrame: 24 hours after surgery
measure: Patient satisfaction
timeFrame: 24 hours after surgery
measure: Block- and opioid-related side effects
timeFrame: 1 week
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
state: Metropolitan
Study officials:
References:
citation: 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.
citation: 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.
citation: Ryu T, Kil BT, Kim JH. Comparison Between Ultrasound-Guided Supraclavicular and Interscalene Brachial Plexus Blocks in Patients Undergoing Arthroscopic Shoulder Surgery: A Prospective, Randomized, Parallel Study. Medicine (Baltimore). 2015 Oct;94(40):e1726. doi: 10.1097/MD.0000000000001726.
citation: Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.
citation: Renes SH, Spoormans HH, Gielen MJ, Rettig HC, van Geffen GJ. Hemidiaphragmatic paresis can be avoided in ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):595-9. doi: 10.1097/aap.0b013e3181bfbd83.
citation: 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.
citation: 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.
citation: 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.
citation: Aliste J, Bravo D, Fernandez D, Layera S, Finlayson RJ, Tran DQ. A Randomized Comparison Between Interscalene and Small-Volume Supraclavicular Blocks for Arthroscopic Shoulder Surgery. Reg Anesth Pain Med. 2018 Aug;43(6):590-595. doi: 10.1097/AAP.0000000000000767.