Skip to main content
OpenTrials
Completed

NCT Number: NCT03797924

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nerve Block Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Florida

Gainesville, Florida, 32618, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Receive ICBN with ropivacaine

Drug

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 names: Naropin

No ICBN block

Behavioral

The site of injection will be prepped with tinted chlorhexidine

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: ICBN

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 9, 2019
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.