Pain Clinical Trial
— ICBNOfficial title:
Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?
Verified date | May 2022 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | December 13, 2021 |
Est. primary completion date | December 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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. — View Citation
Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80. — View Citation
MacIver MB, Tanelian DL. Activation of C fibers by metabolic perturbations associated with tourniquet ischemia. Anesthesiology. 1992 Apr;76(4):617-23. — View Citation
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. — View Citation
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. — View Citation
Valli H, Rosenberg PH, Kyttä 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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