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Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block?

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ClinicalTrials.gov Identifier: NCT02893228
Recruitment Status : Unknown
Verified January 2018 by Karthikeyan Kallidaikurichi Srinivasan, The Adelaide and Meath Hospital, incorporating The National Children's Hospital.
Recruitment status was:  Recruiting
First Posted : September 8, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Karthikeyan Kallidaikurichi Srinivasan, The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Brief Summary:
Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an incidence of up to 100%. Mechanism of palsy is thought to be related to spread of local anaesthetic anterior to the anterior scalene muscle. We hypothesize that by injecting saline in this anatomical location prior to performing an interscalene block the incidence of phrenic palsy will be reduced.

Condition or disease Intervention/treatment Phase
Phrenic Nerve Palsy Procedure: Saline Drug: Levobupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block?
Study Start Date : October 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group S (saline group)
In plane posterior approach will be used with a 50mm short bevel block needle (Braun), advanced through the middle scalene muscle. At the location chosen for interscalene block the needle tip will be positioned anterior to the anterior scalene muscle. At this point 10ml of 0.9% saline will be injected. This will be followed by repositioning of the needle between roots C5 and C6 where 20 ml of 0.25% levobupivicaine will be injected in 5ml increments with intermittent aspiration.
Procedure: Saline
At the location chosen for interscalene block the needle tip will be positioned anterior to the anterior scalene muscle. At this point 10ml of 0.9% saline will be injected.

Drug: Levobupivacaine
the needle tip will then be positioned between C5 and C6 nerve roots. At this location, 20 ml of 0.25% levobupivacaine will be injected in 5 ml increments with intermittent aspiration. The needle tip will not be repositioned unless the patient complaints of paraesthesia

Active Comparator: Group C (control group)
In plane posterior approach will be used with a 50mm short bevel block needle (Braun), advanced through the middle scalene muscle. The needle tip will be positioned between roots C5 and C6 where 20 ml of 0.25% levobupivicaine will be injected in 5ml increments with intermittent aspiration.
Drug: Levobupivacaine
the needle tip will then be positioned between C5 and C6 nerve roots. At this location, 20 ml of 0.25% levobupivacaine will be injected in 5 ml increments with intermittent aspiration. The needle tip will not be repositioned unless the patient complaints of paraesthesia




Primary Outcome Measures :
  1. Rate of diaphragmatic paresis recorded in the post-operative period identified by ultrasound assessment [ Time Frame: 4 hours ]
    Diaphragmatic paresis will be documented with greater than 75% reduction in excursion compared to baseline


Secondary Outcome Measures :
  1. FEV1 [ Time Frame: 4 hours ]
    Forced expiratory volume in 1 second (FEV1)

  2. FVC [ Time Frame: 4 hours ]
    Forced vital capacity (FVC)

  3. PEFR [ Time Frame: 4 hours ]
    Peak expiratory flow rate (PEFR) will be assessed and compared to baseline

  4. Pain control [ Time Frame: 24 hours post-opertive ]
    Intra-operative fentanyl consumption, post-operative morphine consumption in 24 hours, pain scores (numerical 1-10) on arrival in recovery and at 24 hours post operatively


Other Outcome Measures:
  1. Patient satisfaction [ Time Frame: 4 hours ]
    Patient satisfaction scores obtained prior to discharge from recovery will be obtained by numerical rating score 0-10



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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 surgery on shoulder, humerus, or clavicle

Exclusion Criteria:

  • Patient refusal
  • Allergy to local anaesthesia
  • Severe coagulopathy
  • Contralateral phrenic nerve palsy
  • Local infection
  • Moderate to severe pulmonary dysfunction (GOLD II, II, IV)

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): NCT02893228


Contacts
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Contact: Karthikeyan K Srinivasan, MD.,FCARCSI 014142653 k.srinivasan@amnch.ie
Contact: Lindi Snyman, MBBCh.,FCAI 014142653 lindisnyman@gmail.com

Locations
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Ireland
Adelaide and Meath Hospital, Incorporating National Children Hospital Recruiting
Tallagh, Dublin 24, Ireland
Sponsors and Collaborators
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Investigators
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Principal Investigator: Karthikeyan Srinivasan, MD., FCARCSI Adelaide and Meathe Hospital, Incorporating National Children's Hospital
Publications:

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Responsible Party: Karthikeyan Kallidaikurichi Srinivasan, Doctor, The Adelaide and Meath Hospital, incorporating The National Children's Hospital
ClinicalTrials.gov Identifier: NCT02893228    
Other Study ID Numbers: AMNCH-A-SIPPIB
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 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 Karthikeyan Kallidaikurichi Srinivasan, The Adelaide and Meath Hospital, incorporating The National Children's Hospital:
forced expiratory volume in 1 second
forced vital capacity
peak expiratory flow rate
interscalene block
diaphragmatic paresis
Additional relevant MeSH terms:
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Muscle Weakness
Paresis
Neurologic Manifestations
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents