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Interscalene Block Versus Costoclavicular 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
Costoclavicular Infraclavicular 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 focused on measuring Postoperative Shoulder Analgesia, Hemidiaphragmatic Paralysis, Alternative blocks

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 infraclavicular fossa
  • Chronic pain syndromes requiring opioid intake at home

Sites / Locations

  • Hospital Clínico Universidad de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Interscalene Block

Costoclavicular Infraclavicular Block

Arm Description

Patients randomized to receive an intesrcalene block.

Patients randomized to receive a costoclavicular infraclavicular 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 costoclavicular infraclavicular block
Ultrasound diagnosed HDP
Incidence of HDP at 30 minutes after arrival to PACU
Ultrasound diagnosed HDP
Block performance time
Time from skin disinfection until the end of local anesthetic injection
Sensory and Motor block score
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
January 5, 2018
Last Updated
July 8, 2018
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT03411343
Brief Title
Interscalene Block Versus Costoclavicular Block for Shoulder Surgery
Official Title
A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
July 6, 2018 (Actual)
Study Completion Date
July 6, 2018 (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 (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.

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
Keywords
Postoperative Shoulder Analgesia, Hemidiaphragmatic Paralysis, Alternative blocks

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care 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 intesrcalene block.
Arm Title
Costoclavicular Infraclavicular Block
Arm Type
Experimental
Arm Description
Patients randomized to receive a costoclavicular infraclavicular block.
Intervention Type
Procedure
Intervention Name(s)
Interscalene Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Costoclavicular Infraclavicular Block
Intervention Description
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.
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 costoclavicular infraclavicular 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 the PACU
Title
Block performance time
Description
Time from skin disinfection until the end of local anesthetic injection
Time Frame
1 hour before surgery
Title
Sensory and Motor block score
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 infraclavicular fossa Chronic pain syndromes requiring opioid intake at home
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8380456
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19282714
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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12606927
Citation
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Results Reference
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Citation
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Results Reference
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Results Reference
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Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

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