Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

Pain, Postoperative Clinical Trial

Official title:

A Randomized Comparison Between Interscalene and Supraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224884
• Other study ID #: 888/17
• Status: Completed
• Phase: N/A
• First received: July 18, 2017
• Last updated: November 11, 2017
• Start date: July 24, 2017
• Est. completion date: October 25, 2017

Study information

• Verified date: November 2017
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diaphragmatic Paralysis
• Pain, Postoperative
• Paralysis
• Respiratory Paralysis
• Shoulder Pain
• Surgical Procedure, Unspecified

Intervention

Procedure:
• Interscalene block
Ultrasound guided brachial plexus block injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in the interscalene groove, under the prevertebral fascia.
• Supraclavicular block
Ultrasound guided brachial plexus injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL (3 mL in the "corner pocket" followed by 17 mL posterolateral to the brachial plexus).

Locations

Country	Name	City	State
Chile	Hospital Clinico Universidad de Chile	Santiago	Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (8)

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. Epub 2005 Dec 6. — View 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. Review. Er — View 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. — View 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):e172 — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static pain at 30 minutes after arrival in the PACU	Evaluated with a NRS from 0 to 10.	30 minutes
Secondary	Static pain at 60 minutes after arrival in the PACU	Evaluated with a NRS from 0 to 10.	60 minutes
Secondary	Postoperative static pain at 2 hours	Evaluated with a NRS from 0 to 10.	2 hours
Secondary	Postoperative static pain at 3 hours	Evaluated with a NRS from 0 to 10.	3 hours
Secondary	Postoperative static pain at 6 hours	Evaluated with a NRS from 0 to 10.	6 hours
Secondary	Postoperative static pain at 12 hours	Evaluated with a NRS from 0 to 10.	12 hours
Secondary	Postoperative static pain at 24 hours	Evaluated with a NRS from 0 to 10.	24 hours
Secondary	Incidence of HDP at 30 minutes after interscalene or supraclavicular block	Ultrasound diagnosed HDP	30 minutes post injection
Secondary	Incidence of HDP at 30 minutes after arrival to PACU.	Ultrasound diagnosed HDP	30 minutes after arrival to PACU
Secondary	Block performance time	Time from skin desinfection until the end of local anesthetic injection.	1 hour before surgery
Secondary	Sensory and Motor block	Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score.	30 minutes post injection
Secondary	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
Secondary	Procedural pain during blocks	Evaluated with a NRS from 0 to 10.	1 hour before surgery
Secondary	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
Secondary	Intraoperative opioid requirements	Total amount of fentanyl required during general anesthesia.	Intraoperative period
Secondary	Surgical duration	Time between skin incision and closure.	intraoperative period
Secondary	Postoperative opioid consumption	Total amount of morphine required during the first 24 hours after surgery.	24 hours after surgery
Secondary	Patient satisfaction	Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 = very satisfied).	24 hours after surgery
Secondary	Block- and opioid-related side effects	Incidence of side effects.	1 week