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

NCT03797924 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: IRB201802525OCR19802
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Block; Pain

Keywords

Intercostobrachial Nerve Block; Tourniquet Pain; Upper Limb Surgeries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

  From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)

• Change between the 2 groups assessed by intraoperative opioid consumption

  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

  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

  From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)

Study Arms (2)

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.

Drug: Receive ICBN with ropivacaine

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.

Behavioral: No ICBN block

Interventions

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.

Also known as: Naropin

ICBN with ropivacaine

No ICBN block BEHAVIORAL

The site of injection will be prepped with tinted chlorhexidine

No ICBN block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32618, United States

Location

Related Publications (6)

• 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.

  PMID: 23053464 RESULT

• Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80.

  PMID: 3767015 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.

  PMID: 3591250 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.

  PMID: 8092519 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.

  PMID: 1550287 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.

  PMID: 9613307 RESULT

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Linda Le-Wendling, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 9, 2019
• Study Start: April 25, 2019
• Primary Completion: December 20, 2020
• Study Completion: December 13, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)