Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perfusion Index in Detection of Ulnar Nerve Sparing During Supraclavicular 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03880201
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Bassant M. Abdelhamid, Cairo University

Brief Summary:
The aim of this study to evaluate the ability of perfusion index to detect ulnar sparing and to estimate the proper time for the perfusion index ratio to determine successful block.

Condition or disease Intervention/treatment
Perfusion Index as an Early Predictor of Ulnar Nerve Sparing in Supraclavicular Block Perfusion Index as an Early Predictor of Successful Supraclavicular Block Procedure: ultrasound guided supraclavicular block Device: Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Evaluation of the Ability of Perfusion Index in Detection of Ulnar Nerve Sparing During Ultra Sound Guided Supraclavicular Block
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : June 28, 2019

Group/Cohort Intervention/treatment
patient undergoing upper limb orthopaedic surgery
The study will be performed on patient undergoing upper limb orthopaedic surgery which will be performed under ultrasound guided supraclavicular block.
Procedure: ultrasound guided supraclavicular block

The linear transducer will be applied firmly above the clavicle in the coronal oblique plane the 22-gauge needle will be inserted at the lateral side of the ultrasound probe using In-plane approach. The needle will be advanced towards the target nerves inferior, lateral and superficial to subclavian artery respectively. Local anesthetic solution is injected between 20 to 25 ml.

Motor block will be assessed as follow Radial nerve = Push the arm by extending the forearm at the elbow against the resistance, musculocutaneous nerve = Resisting the pull of the forearm at the elbow, median nerve = Thumb and second digit pinch, ulnar nerve = Thumb and fifth digit pinch.

Sensory block will be assessed by using piece of ice in the distribution of median, ulnar, radial and musculocutaneous nerves.


Device: Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)
Masimo reading of PI values will be recorded every minute (at both index and fifth digits) for 20 minutes then every 3 minutes for 30 minutes.




Primary Outcome Measures :
  1. PI ratio in the little digit [ Time Frame: 10 minutes after block ]
    PI ratio is defined as PI at 10 minutes / PI at the baseline


Secondary Outcome Measures :
  1. PI ratio in the index digit [ Time Frame: 10 minutes after block ]
    PI ratio is defined as PI at 10 minutes / PI at the baseline

  2. PI values in the index digit [ Time Frame: every minute for 20 minutes then every 3 minutes for 30 minutes ]
    PI values is recorded every minute for 20 minutes then every 3 minutes for 30 minutes.

  3. PI values in the little digit [ Time Frame: every minute for 20 minutes then every 3 minutes for 30 minutes ]
    PI values is recorded every minute for 20 minutes then every 3 minutes for 30 minutes.

  4. Time needed to reach the maximum PI [ Time Frame: every minute for 20 minutes then every 3 minutes for 30 minutes. ]
    PI values is recorded every minute for 20 minutes then every 3 minutes for 30 minutes.

  5. Time needed to reach the maximum PI ratio [ Time Frame: every minute for 20 minutes then every 3 minutes for 30 minutes. ]
    PI ratio is calculated as PI at each minute after block / PI at the baseline

  6. Incidence of ulnar nerve sparing [ Time Frame: for 30 minutes after block ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study will be performed on patient undergoing upper limb orthopaedic surgery which will be performed under ultrasound guided supraclavicular block.
Criteria

Inclusion Criteria:

  • Age between 18 and 60 years and weight 60-90 kg.
  • ASA physical status classification I- II
  • Patients scheduled for elective upper limb surgery

Exclusion Criteria:

  • • upper limb ischemia

    • Diabetic neuropathy
    • Known contraindications to regional anaesthetic techniques as coagulopathy.
    • ASA physical status class III-IV.
    • Hypovolemic patients.

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): NCT03880201


Contacts
Layout table for location contacts
Contact: Ahmed M hasanin, MD 01095076954 ahmedmohamedhasanin@gmail.com
Contact: Bassant abdelhamid, MD 01224254012 bassantmohamed197@yahoo.com

Locations
Layout table for location information
Egypt
Cairo university Recruiting
Cairo, Egypt, 11562
Contact: Bassant M. Abdelhamid, M. D.    01224254012 ext 002    Bassantmohamed197@yahoo.com   
Contact: Ahmed M. Hasanin, M. D.    +201095076954 ext 002    Ahmedmohamedhasanin@gmail.com   
Sub-Investigator: Mohamed Emam, Master         
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: Ahmed Hasanin, MD Cairo University
Principal Investigator: Bassant abdelhamid, MD Cairo University
Study Director: Mohamed Emam, Master Cairo University

Additional Information:

Publications:
Layout table for additonal information
Responsible Party: Bassant M. Abdelhamid, associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT03880201     History of Changes
Other Study ID Numbers: N-30-2018
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bassant M. Abdelhamid, Cairo University:
perfusion index.ulnar nerve sparing. supraclavicular blocK