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. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03909594

Recruitment Status : Withdrawn (The COVID Pandemic delayed start of study and currently the investigators are not interested in conducting the study.)

First Posted : April 10, 2019

Last Update Posted : October 11, 2021

Sponsor:

Information provided by (Responsible Party):

Antonios Likourezos, Maimonides Medical Center

Study Description

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

Show detailed description

Detailed Description:

STUDY DESIGN

Subjects: Patients aged 18 years and older with isolated hip or femur fracture confirmed on x-ray.

DESIGN:

A randomized double-blind prospective superiority trail.

Each patient will receive Morphine for analgesia prior to regional nerve block.
- Patients < 65 years will receive Morphine 0.1 mg/kg every four hours as needed for 2 doses
- Patients > 65 years will receive Morphine 0.05 mg/kg every four hours as needed for 2 doses
Treatment group: 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.
Control group: 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
The patients will be followed with respect to accrual time, follow up time, and total time of the block as well as a need for rescue analgesia as follows: every 15 minutes for the first hour; every 30 minutes for the next hour; every 1 hour for next 4 hours; every 4 hours for next 18 hours with end point of 24 hours or up until they are taken to surgery, whichever comes first.
Evaluation of the sensory blocks: will be performed every 5 minutes after administration of the local anesthetic. The sensory block will be quantified as: 0 = Anesthesia (no sensation), 1 = Analgesia (decreased [dull] sensation), and 2 = no block (normal sensation), by using the pinprick test and comparing with the contralateral limb. The time elapsed from the injection to the onset of analgesia in the central sensory region of femoral nerve block will be taken as time of onset of the sensory block.
Rescue Analgesia: If pain is not relieved and the participant requires rescue analgesia a weight-based dose of Morphine will be given at 0.1 mg/kg.

In addition, an antidote (lipid emulsion) that will be given to patients who need it when they develop severe side effects.

DATA COLLECTION:

Patient demographic, clinical and injury information, pain score, onset of motor and sensory block, rescue analgesia and side effects/adverse events will be collected by using a data collection form by trained research assistant and associates.

DATA ANALYSIS:

Statistical Analyses will include frequency distributions, t-test and chi-square for comparison between and within the groups and Cox Linear Regression Analysis. P<.05 will denote statistical significance. Statistical analyses will be conducted via SPSS version 24. Antonios Likourezos or equivalent will perform the statistical analyses.

EXPECTED OUTCOMES:

PRIMARY OUTCOME: time to first rescue analgesia post-regional nerve blockade in each group

SECONDARY OUTCOMES:

• Change in pain score as measured by Visual Analog Scale: Patient to be approached at the following intervals: every 15 minutes for the first hour; every 30 minutes for the next hour; every 1 hour for next 4 hours; every 4 hours for next 18 hours with end point of 24 hours or up until they are taken to surgery, whichever comes first.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 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 :	January 1, 2022
Estimated Primary Completion Date :	December 31, 2023
Estimated Study Completion Date :	December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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)

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

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)

Contacts and Locations

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

Locations

Layout table for location information

United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219

Sponsors and Collaborators

Antonios Likourezos

Investigators

Layout table for investigator information

Principal Investigator:	Sergey Motov, MD	Maimonides Medical Center

Study Documents (Full-Text)

Documents provided by Antonios Likourezos, Maimonides Medical Center:

Study Protocol and Statistical Analysis Plan [PDF] October 26, 2018

More Information

Layout table for additonal information

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:	October 11, 2021
Last Verified:	October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

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:

Layout table for MeSH terms

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

To Top