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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03797924
Other study ID # IRB201802525
Secondary ID OCR19802
Status Completed
Phase Early Phase 1
First received
Last updated
Start date April 25, 2019
Est. completion date December 13, 2021

Study information

Verified date May 2022
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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.
Behavioral:
No ICBN block
The site of injection will be prepped with tinted chlorhexidine

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

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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