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Clinical Trials/NCT03797924
NCT03797924
Completed
Early Phase 1

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

University of Florida1 site in 1 country46 target enrollmentApril 25, 2019

Overview

Phase
Early Phase 1
Intervention
Receive ICBN with ropivacaine
Conditions
Nerve Block
Sponsor
University of Florida
Enrollment
46
Locations
1
Primary Endpoint
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)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 25, 2019
End Date
December 13, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

ICBN with ropivacaine

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.

Intervention: Receive ICBN with ropivacaine

No ICBN block

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.

Intervention: No ICBN block

Outcomes

Primary Outcomes

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)

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

Tourniquet pain defined by the presence of dull or aching pain underneath the tourniquet

Secondary Outcomes

  • 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 Sites (1)

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