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Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331237
Recruitment Status : Unknown
Verified October 2017 by Ahmad Muhammad Taha, Healthpoint Hospital.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmad Muhammad Taha, Healthpoint Hospital

Brief Summary:

For shoulder analgesia, both ISO block and low volume scalene (LVS) block (using 5 ml of local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis (HDP).

The aim of this study was to compare the incidence of HDP and the analgesic efficacy of the LVS block versus ISO block.


Condition or disease Intervention/treatment Phase
Shoulder Arthropathy Associated With Other Conditions Procedure: scalene block Procedure: ISO block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Shoulder Analgesia Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block. A Randomized Controlled Double Blind Study
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Active Comparator: LVS group
interscalene injection
Procedure: scalene block
scalene block using 5ml of ropivacaine

Active Comparator: ISO group
in this group all patients will receive ISO block.
Procedure: ISO block
ISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture




Primary Outcome Measures :
  1. hemi-diaphragmatic pariesis [ Time Frame: 2-4 hours ]
    diaphragmatic caudal displacement will be measured (in cm) with real time ultrasound before the block performance and after the procedure


Secondary Outcome Measures :
  1. analgesic efficacy (block success) [ Time Frame: 2-4 hours ]
    successful block = pain free (VAS 0) in recovery unit. VAS will be used to evaluate the pain (0 = pain free, 10= most sever pain)

  2. patient satisfaction [ Time Frame: 24 hours ]
    if the patient is satisfied with the analgesia technique or not

  3. duration of analgesia [ Time Frame: 24 hours ]
    duration between the block performance and the first requesting of pain killer (morphine)

  4. total morphine dose [ Time Frame: 24 hours ]
    the total morphine consumption within 24 hrs after the block performance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who were scheduled for arthroscopic shoulder surgery

Exclusion Criteria:

  • aged <18y
  • BMI >35,
  • ASA greater >III,
  • an infection at the injection site
  • has a contraindication for laryngeal mask or the medications used in this study.

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): NCT03331237


Contacts
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Contact: Sabah Zahooruddin 009712 4929000 ext 1304 s.zahooruddin@helathpoint.ae

Locations
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United Arab Emirates
Healthpoint Hospital Recruiting
Abu Dhabi, United Arab Emirates, 112308
Contact: Sabah Zahooruddin    +971 2 4921304    s.zahooruddin@healthpoint.ae   
Sponsors and Collaborators
Healthpoint Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmad Muhammad Taha, Consultant of aneathesia, Healthpoint Hospital
ClinicalTrials.gov Identifier: NCT03331237    
Other Study ID Numbers: REC007
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
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
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases