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

NCT03909594 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2018-08-05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Musculoskeletal

Outcome Measures

Primary Outcomes (1)

• time to first rescue analgesia post-regional nerve blockade

  The difference in time from administration of pain medication to rescue analgesia

  0-24 hours

Secondary Outcomes (1)

• Pain score at 30 minutes

  30 minutes

Study Arms (2)

Nerve Block with Bupivacaine an

EXPERIMENTAL

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; Drug: Ketamine

Nerve Block with Bupivacaine al

ACTIVE COMPARATOR

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

Interventions

Bupivacaine DRUG

Bupivacaine

Nerve Block with Bupivacaine al; Nerve Block with Bupivacaine an

Ketamine DRUG

Ketamine

Nerve Block with Bupivacaine an

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Bupivacaine; Ketamine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a randomized double blind study - - All the pharmacist and research manager
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager; Co-Investigator

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 10, 2019
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)