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Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT03411343
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Julian Aliste, University of Chile

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Shoulder Pain Surgical Procedure, Unspecified Diaphragmatic Paralysis Procedure: Interscalene Block Procedure: Costoclavicular Infraclavicular Block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery
Actual Study Start Date : April 9, 2018
Actual Primary Completion Date : July 6, 2018
Actual Study Completion Date : July 6, 2018

Arm Intervention/treatment
Active Comparator: Interscalene Block
Patients randomized to receive an intesrcalene block.
Procedure: Interscalene Block
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.

Experimental: Costoclavicular Infraclavicular Block
Patients randomized to receive a costoclavicular infraclavicular block.
Procedure: Costoclavicular Infraclavicular Block
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 Measures :
  1. Static pain at 30 minutes after arrival in the PACU [ Time Frame: 30 minutes ]
    Evaluated with a NRS from 0 to 10


Secondary Outcome Measures :
  1. Static pain at 60 minutes after arrival in the PACU [ Time Frame: 60 minutes ]
    Evaluated with a NRS from 0 to 10

  2. Postoperative static pain at 2 hours [ Time Frame: 2 hours ]
    Evaluated with a NRS from 0 to 10

  3. Postoperative static pain at 3 hours [ Time Frame: 3 hours ]
    Evaluated with a NRS from 0 to 10

  4. Postoperative static pain at 6 hours [ Time Frame: 6 hours ]
    Evaluated with a NRS from 0 to 10

  5. Postoperative static pain at 12 hours [ Time Frame: 12 hours ]
    Evaluated with a NRS from 0 to 10

  6. Postoperative static pain at 24 hours [ Time Frame: 24 hours ]
    Evaluated with a NRS from 0 to 10

  7. Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block [ Time Frame: 30 minutes post injection ]
    Ultrasound diagnosed HDP

  8. Incidence of HDP at 30 minutes after arrival to PACU [ Time Frame: 30 minutes after arrival to the PACU ]
    Ultrasound diagnosed HDP

  9. Block performance time [ Time Frame: 1 hour before surgery ]
    Time from skin disinfection until the end of local anesthetic injection

  10. Sensory and Motor block score [ Time Frame: 30 minutes post injection ]
    Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score

  11. Incidence of complete block [ Time Frame: 30 minutes post injection ]
    Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection

  12. Procedural pain during blocks [ Time Frame: 1 hour before surgery ]
    Evaluated with a NRS from 0 to 10

  13. Onset time [ Time Frame: 1 hour before surgery ]
    Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points

  14. Intraoperative opioid requirements [ Time Frame: Intraoperative period ]
    Total amount of fentanyl required during general anesthesia

  15. Surgical duration [ Time Frame: Intraoperative period ]
    Time between skin incision and closure

  16. Postoperative opioid consumption [ Time Frame: 24 hours after surgery ]
    Total amount of morphine required during the first 24 hours after surgery

  17. Patient satisfaction [ Time Frame: 24 hours after surgery ]
    Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)

  18. Block- and opioid-related side effects [ Time Frame: 1 week ]
    Incidence of side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411343


Locations
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Chile
Hospital Clínico Universidad de Chile
Santiago, Metropolitana, Chile, 8380456
Sponsors and Collaborators
University of Chile
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julian Aliste, Clinical Instructor, Department of Anesthesia, University of Chile
ClinicalTrials.gov Identifier: NCT03411343    
Other Study ID Numbers: 889/17
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julian Aliste, University of Chile:
Postoperative Shoulder Analgesia
Hemidiaphragmatic Paralysis
Alternative blocks
Additional relevant MeSH terms:
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Shoulder Pain
Respiratory Paralysis
Paralysis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases