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| ID | Type | Description | Link |
|---|---|---|---|
| OCR19802 | Other Identifier | OnCore |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICBN with ropivacaine | Active Comparator | 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. |
|
| No ICBN block | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receive ICBN with ropivacaine | Drug | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Le-Wendling, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32618 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23053464 | Result | 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. | |
| 3767015 | Result | Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.
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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.
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| No ICBN block | Behavioral | The site of injection will be prepped with tinted chlorhexidine |
|
| 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) |
| 3591250 | Result | 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. |
| 8092519 | Result | 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. |
| 1550287 | Result | 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. |
| 9613307 | Result | 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. |
| D000588 |
| Amines |