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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-25

Study Completion Date

2021-12-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Out of Plane Approach for Interscalene

NCT03785392

Acute Pain Brachial Plexus Block

TERMINATED NA

ISB With SSNB & ANB

NCT06878391

Rotator Cuff Tear

RECRUITING NA

Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery

NCT02287142

Pain, Postoperative Pain Shoulder Joint +1 more

COMPLETED NA

Interscalene Versus Combined Infraclavicular-suprascapular Nerve Blocks

NCT03628950

Postoperative Pain

COMPLETED NA

Ultrasound Guided Intercostobrachial Nerve Block

NCT02805582

Anaesthesia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nerve Block Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Receive ICBN with ropivacaine

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

No ICBN block

Intervention Type BEHAVIORAL

The site of injection will be prepped with tinted chlorhexidine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

No ICBN block

The site of injection will be prepped with tinted chlorhexidine

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Naropin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No