Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?

Pain Clinical Trial

— ICBN  

Official title:

Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797924
• Other study ID #: IRB201802525
• Secondary ID: OCR19802
• Status: Completed
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Nerve Block
• Pain

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)