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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nerve Block, Pain

Intervention / Treatment
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* Drug: Receive ICBN with ropivacaine
* Behavioral: No ICBN block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICBN with ropivacaine<br>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<br>* 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.<br>* Other names: Naropin;|
| Placebo Comparator: No ICBN block<br>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<br>* The site of injection will be prepped with tinted chlorhexidine<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intercostobrachial Nerve Block, Tourniquet Pain, Upper Limb Surgeries