Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- 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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Receive ICBN with ropivacaine (Drug)
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.
Intervention: No ICBN block (Behavioral)
Outcomes
Primary Outcomes
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
- 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))
- Change between the 2 groups assessed by intraoperative opioid consumption(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(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(From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours))