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Bubiket Study: Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03909594
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Brief Summary:
The project is meant to evaluate the effect of a combination of medications (Bupivacaine + Ketamine) used in an ultra-sound guided nerve block for patients presenting to the Emergency Department (ED) with hip and/or femur fractures. The goal is to see whether the combination of these two medications will result in greater and longer-lasting pain relief, longer-lasting motor and sensory block and overall less need for opioid rescue analgesia.

Condition or disease Intervention/treatment Phase
Pain, Musculoskeletal Drug: Bupivacaine Drug: Ketamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a randomized double blind study - - All the pharmacist and research manager
Primary Purpose: Treatment
Official Title: Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone in Patients With Hip or Femur Fracture: a Double Blind Randomized Clinical Trial (BupiKet)
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Nerve Block with Bupivacaine an
Patients will receive an ultrasound guided regional nerve block with Bupivacaine (0.5% or 5 mg/ml) 2.5 mg/kg (max dose 175 kg) + Ketamine (50 mg/ml) 2 mg/kg. Each patient will be given a volume of 40 mL - this will be a mixture of Bupivacaine, Ketamine and 0.9% NS to make up the full 40 ml.
Drug: Bupivacaine
Bupivacaine

Drug: Ketamine
Ketamine

Active Comparator: Nerve Block with Bupivacaine al
Patients will receive an ultrasound guided regional nerve block with Bupivacaine 0.5% only. Each patient will be given a volume of 40 ml - this will be a mixture of Bupivacaine and 0.9% NS to make up the full volume of 40 mL
Drug: Bupivacaine
Bupivacaine




Primary Outcome Measures :
  1. time to first rescue analgesia post-regional nerve blockade [ Time Frame: 0-24 hours ]
    The difference in time from administration of pain medication to rescue analgesia


Secondary Outcome Measures :
  1. Pain score at 30 minutes [ Time Frame: 30 minutes ]
    The pain score at 30 minutes at an 11 point Likert Numeric Rating Scale (0 = no pain; 5=moderate pain, and 10 = very severe pain)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • Presenting with isolated hip or femur fracture confirmed on x-ray.

Exclusion Criteria:

  • Polytrauma
  • Unstable vitals signs
  • Allergy to Bupivacaine or Ketamine
  • Inability to give consent
  • Altered mental status
  • Greater than 100kg
  • Known end stage renal disease or hepatic dysfunction
  • Received > 2 doses of Morphine in ER prior to regional nerve block
  • Patients with failed nerve block (30 minute onset)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909594


Contacts
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Contact: Antonios Likourezos, MPH 718-283-6896 alikourezos@maimonidesmed.org
Contact: Sergeu Motov, MD 718-283-8693 smotov@maimonidesmed.org

Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Contact: Antonios Likourezos, MPH       alikourezos@maimonidesmed.org   
Contact: Sergey Motov, MD       smotov@maimonidesmed.org   
Sponsors and Collaborators
Antonios Likourezos
Investigators
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Principal Investigator: Sergey Motov, MD Maimonides Medical Center
  Study Documents (Full-Text)

Documents provided by Antonios Likourezos, Maimonides Medical Center:
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Responsible Party: Antonios Likourezos, Research Manager; Co-Investigator, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT03909594    
Other Study ID Numbers: 2018-08-05
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Ketamine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action