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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Nerve Block
• Intervention / Treatment: Drug: Receive ICBN with ropivacaine; Behavioral: No ICBN block

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
• Enrollment (Actual): 46
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32618
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Tourniquet pain defined by the presence of dull or aching pain underneath the tourniquet	From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Determine required depth of anesthesia during surgery to alleviate tourniquet pain	From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Change between the 2 groups assessed by intraoperative opioid consumption	Determine amount of intraoperative opioid consumption due to tourniquet pain	From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Change between the 2 groups assessed by time to onset of tourniquet pain	Determine the time to onset of tourniquet pain	From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Change between the 2 groups in reported severity of tourniquet pain	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.	From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Linda Le-Wendling, MD, University of Florida

Publications and helpful links

General Publications

• Satsumae T, Yamaguchi H, Inomata S, Tanaka M. Magnesium sulfate attenuates tourniquet pain in healthy volunteers. J Anesth. 2013 Apr;27(2):231-5. doi: 10.1007/s00540-012-1493-4. Epub 2012 Oct 7.
• Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80.
• Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x.
• Crews JC, Cahall M, Behbehani MM. The neurophysiologic mechanisms of tourniquet pain. The activity of neurons in the rostroventral medulla in the rat. Anesthesiology. 1994 Sep;81(3):730-6. doi: 10.1097/00000542-199409000-00027.
• MacIver MB, Tanelian DL. Activation of C fibers by metabolic perturbations associated with tourniquet ischemia. Anesthesiology. 1992 Apr;76(4):617-23. doi: 10.1097/00000542-199204000-00020.
• Tschaikowsky K, Hemmerling T. Comparison of the effect of EMLA and semicircular subcutaneous anaesthesia in the prevention of tourniquet pain during plexus block anaesthesia of the arm. Anaesthesia. 1998 Apr;53(4):390-3. doi: 10.1046/j.1365-2044.1998.00301.x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2019
• Primary Completion (ACTUAL): December 20, 2020
• Study Completion (ACTUAL): December 13, 2021

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (ACTUAL): January 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Intercostobrachial Nerve Block; Tourniquet Pain; Upper Limb Surgeries
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: IRB201802525; OCR19802 (OTHER: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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