Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03909594 |
| Other study ID # |
2018-08-05 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
October 2021 |
| Source |
Maimonides Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
