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Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary? (ICBN)

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ClinicalTrials.gov Identifier: NCT03797924
Recruitment Status : Not yet recruiting
First Posted : January 9, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
In this study the investigators would like to show that when patients undergo upper limb surgery under supraclavicular brachial plexus block, additional blocking of the Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet pain.

Condition or disease Intervention/treatment Phase
Nerve Block Pain Drug: Receive ICBN with ropivacaine Behavioral: No ICBN block Early Phase 1

Detailed Description:
The ICBN is a cutaneous sensory nerve that supplies the medial aspect of the upper arm. Traditionally this nerve is blocked to alleviate tourniquet pain. The etiology of tourniquet pain is complex and the study team hypothesize that blocking the ICBN has no impact on tourniquet pain. Patients will receive a supraclavicular block and be divided into two groups; ICBN with local anesthetic or ICBN with saline. All patients in this study will receive a supraclavicular block as their primary anesthetic and then be divided into two groups; those who receive ICBN and those who do not. Amount of intraoperative analgesics, conversion to deep sedation or general anesthesia, and onset of time to tourniquet pain will be the primary measures of this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.
Masking: Double (Participant, Care Provider)
Masking Description: In order to blind anesthesia providers in the room and nurses in Post-op Anesthesia Care Unit (PACU), the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.
Primary Purpose: Basic Science
Official Title: Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ICBN with ropivacaine
Participants will receive ICBN with ropivacaine. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.
Drug: Receive ICBN with ropivacaine
ICBN block will be performed using US guidance depositing 10 ml of 0.5% ropivacaine in the plane between pectoralis minor and serratus anterior over the 2nd and 3rd intercostal space.
Other Name: Naropin

Placebo Comparator: No ICBN block
Participants will have the site prepped, but no ICBN block given. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.
Behavioral: No ICBN block
The site of injection will be prepped with tinted chlorhexidine




Primary Outcome Measures :
  1. Change between the 2 groups assessed by the incidence of tourniquet pain reported by the patient on a Descriptor Differential Scale of Pain Intensity (DDSI) [ Time Frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) ]
    Tourniquet pain defined by the presence of dull or aching pain underneath the tourniquet


Secondary Outcome Measures :
  1. Change between the 2 groups depth of anesthesia during surgery to alleviate tourniquet pain as assessed by the American Society of Anesthesiologist (ASA) Continuum of Depth of Sedation definition of general anesthesia and levels of sedation/analgesia. [ Time Frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) ]
    Determine required depth of anesthesia during surgery to alleviate tourniquet pain

  2. Change between the 2 groups assessed by intraoperative opioid consumption [ Time Frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) ]
    Determine amount of intraoperative opioid consumption due to tourniquet pain

  3. Change between the 2 groups assessed by time to onset of tourniquet pain [ Time Frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) ]
    Determine the time to onset of tourniquet pain

  4. Change between the 2 groups in reported severity of tourniquet pain [ Time Frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) ]
    Determine if ICBN has an affect on the severity of tourniquet pain as assessed by Descriptor Differential Scale of Pain Intensity (DDSI) There are 10 points along which patients can rate their pain intensity to the right and left of each descriptor, so the pain is rated on a 21 point scale for each descriptor. Pain intensity is defined as a mean of the ratings and can range from 0 to 20.



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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:

  • American Society of Anesthesiologists (ASA) 1-3
  • Distal upper extremity surgery with anticipated use of tourniquet
  • Outpatient surgery
  • Patients who desire regional anesthesia as primary anesthetic

Exclusion Criteria:

  • ASA 4 or greater
  • Allergies to local anesthetic
  • Refusal of regional anesthesia
  • History of chronic pain syndromes
  • Patients who do not desire regional anesthesia as primary anesthetic

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): NCT03797924


Contacts
Contact: Judith M Wishin, BSN 352-293-7076 jwishin@anest.ufl.edu
Contact: Linda Le-Wendling, MD

Locations
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32618
Contact: Judith M Wishin, BSN    352-273-9096    jwishin@anest.ufl.edu   
Contact: Linda Le-Wendling, MD    352-514-2513    lle@anest.ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Linda Le-Wendling, MD University of Florida

Publications of Results:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03797924     History of Changes
Other Study ID Numbers: IRB201802525
OCR19802 ( Other Identifier: OnCore )
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Florida:
Intercostobrachial Nerve Block
Tourniquet Pain
Upper Limb Surgeries

Additional relevant MeSH terms:
Ropivacaine
Chlorhexidine
Chlorhexidine gluconate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents