Skip to content

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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03797924
Acronym
ICBN
Enrollment
46
Registered
2019-01-09
Start date
2019-04-25
Completion date
2021-12-13
Last updated
2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve Block, Pain

Keywords

Intercostobrachial Nerve Block, Tourniquet Pain, Upper Limb Surgeries

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.

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.

Interventions

DRUGReceive 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.

BEHAVIORALNo ICBN block

The site of injection will be prepped with tinted chlorhexidine

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

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.

Intervention model description

Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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)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

MeasureTime frameDescription
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.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
Change between the 2 groups assessed by intraoperative opioid consumptionFrom intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)Determine amount of intraoperative opioid consumption due to tourniquet pain
Change between the 2 groups assessed by time to onset of tourniquet painFrom intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)Determine the time to onset of tourniquet pain
Change between the 2 groups in reported severity of tourniquet painFrom 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026