Clinical trial NCT03797924: Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?
Official title: Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Nerve Block
Pain
Keywords: Intercostobrachial Nerve Block
Tourniquet Pain
Upper Limb Surgeries
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Secondary outcomes:
measure: 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.
timeFrame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
measure: Change between the 2 groups assessed by intraoperative opioid consumption
timeFrame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
measure: Change between the 2 groups assessed by time to onset of tourniquet pain
timeFrame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
measure: Change between the 2 groups in reported severity of tourniquet pain
timeFrame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Linda Le-Wendling, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1046/j.1365-2044.1998.00301.x.