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Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

Primary Purpose

Pain, Postoperative, Shoulder Pain, Surgical Procedure, Unspecified

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Interscalene block
Supraclavicular block
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinico Universidad de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Interscalene block

Supraclavicular block

Arm Description

Patients randomized to receive an interscalene block .

Patients randomized to receive a supraclavicular block.

Outcomes

Primary Outcome Measures

Static pain at 30 minutes after arrival in the PACU
Evaluated with a NRS from 0 to 10.

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2017
Last Updated
November 11, 2017
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT03224884
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Shoulder Pain, Surgical Procedure, Unspecified, Diaphragmatic Paralysis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interscalene block
Arm Type
Active Comparator
Arm Description
Patients randomized to receive an interscalene block .
Arm Title
Supraclavicular block
Arm Type
Experimental
Arm Description
Patients randomized to receive a supraclavicular block.
Intervention Type
Procedure
Intervention Name(s)
Interscalene block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Supraclavicular block
Intervention Description
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).
Primary Outcome Measure Information:
Title
Static pain at 30 minutes after arrival in the PACU
Description
Evaluated with a NRS from 0 to 10.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Static pain at 60 minutes after arrival in the PACU
Description
Evaluated with a NRS from 0 to 10.
Time Frame
60 minutes
Title
Postoperative static pain at 2 hours
Description
Evaluated with a NRS from 0 to 10.
Time Frame
2 hours
Title
Postoperative static pain at 3 hours
Description
Evaluated with a NRS from 0 to 10.
Time Frame
3 hours
Title
Postoperative static pain at 6 hours
Description
Evaluated with a NRS from 0 to 10.
Time Frame
6 hours
Title
Postoperative static pain at 12 hours
Description
Evaluated with a NRS from 0 to 10.
Time Frame
12 hours
Title
Postoperative static pain at 24 hours
Description
Evaluated with a NRS from 0 to 10.
Time Frame
24 hours
Title
Incidence of HDP at 30 minutes after interscalene or supraclavicular block
Description
Ultrasound diagnosed HDP
Time Frame
30 minutes post injection
Title
Incidence of HDP at 30 minutes after arrival to PACU.
Description
Ultrasound diagnosed HDP
Time Frame
30 minutes after arrival to PACU
Title
Block performance time
Description
Time from skin desinfection until the end of local anesthetic injection.
Time Frame
1 hour before surgery
Title
Sensory and Motor block
Description
Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score.
Time Frame
30 minutes post injection
Title
Incidence of complete block
Description
Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection.
Time Frame
30 minutes post injection
Title
Procedural pain during blocks
Description
Evaluated with a NRS from 0 to 10.
Time Frame
1 hour before surgery
Title
Onset time
Description
Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points.
Time Frame
1 hour before surgery
Title
Intraoperative opioid requirements
Description
Total amount of fentanyl required during general anesthesia.
Time Frame
Intraoperative period
Title
Surgical duration
Description
Time between skin incision and closure.
Time Frame
intraoperative period
Title
Postoperative opioid consumption
Description
Total amount of morphine required during the first 24 hours after surgery.
Time Frame
24 hours after surgery
Title
Patient satisfaction
Description
Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 = very satisfied).
Time Frame
24 hours after surgery
Title
Block- and opioid-related side effects
Description
Incidence of side effects.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Clinico Universidad de Chile
City
Santiago
State/Province
Metropolitan
ZIP/Postal Code
8380456
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19282714
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. Erratum In: Reg Anesth Pain Med. 2010 Jul-Aug;35(4):407.
Results Reference
result
PubMed Identifier
2006740
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.
Results Reference
result
PubMed Identifier
26448030
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.
Results Reference
result
PubMed Identifier
27941477
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.
Results Reference
result
PubMed Identifier
19916254
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.
Results Reference
result
PubMed Identifier
20975470
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.
Results Reference
result
PubMed Identifier
21568985
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.
Results Reference
result
PubMed Identifier
16331304
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.
Results Reference
result
PubMed Identifier
29630033
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.
Results Reference
derived

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Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

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