Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04997785 |
Other study ID # |
A10904001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 30, 2021 |
Est. completion date |
May 8, 2022 |
Study information
Verified date |
January 2023 |
Source |
Dalin Tzu Chi General Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study is a multicenter single-blinded randomized comparative trial. Adult patients older
than 20 years of age presenting with acute hip fracture in emergency department between
January 1st, 2021 and December 31st, 2021 will be enrolled. (NOTE: The study was paused
temporarily due to local SARS-2 COVID-19 virus pandemic restrictions. Finally, we conducted
the study from August 30th, 2021 to May 08th, 2022.) Included patients will receive analgesia
with either pericapsular nerve group (PENG) block or intravenous morphine. The primary
outcome measure was pain scores (Numeric Rating Scale (NRS) 0 to 10) at rest and with
movement. Secondary outcomes were rescue opioids use, complications, length of hospital stay,
and patient-reported outcomes.
Description:
Study design and setting This is multicenter, randomized controlled comparative trial
conducted at Far Eastern Memorial Hospital and Dalin Tzu Chi Hospital, which are academic,
level 1 trauma centers in Taiwan. The investigators plan to conduct the study from January
1st to May 8th, 2022. It will be paused temporarily if local coronavirus disease 2019
(COVID-19) virus pandemic restrictions. The trial is registering on ClinicalTrials.gov
number. The study was reviewed and approved by the Institutional Review Board. The study
conforms to the Consolidated Standards of Reporting Trials (CONSORT) and the CONSORT
extension for trials reporting patient- related outcomes.
Selection of participants Patients aged >=20 years presenting to the emergency department
(ED) with a diagnosis of traumatic hip fracture from January 1st to May 8th, 2022 will be
included. The investigators exclude patients who are aged <20 years, have coagulopathy,
injection site infection, allergy to opioids or local anesthetics, initial pulse oximetry
measures of oxygen saturation <92%, initial systolic blood pressure < 90 mmHg, chronic opioid
use, non-communicative, experiences major trauma, fractures happened > 24 hours, and request
conservative(non-operative) treatments. The investigators also exclude patients if the nerve
block (NB) providers are unavailable. Written informed consent is acquired from all
participants.
Randomization procedures and rationale All the included patients are randomized to either
PENG block or intravenous morphine. Because PENG block is a novel technique for regional hip
analgesia, well-trained emergency physicians are not available every day. Randomizing
patients at the point of ED visit was considered impractical. Therefore, the investigators
randomize each visit week before the study begins, and well-trained PENG block providers will
be arranged on duty in the weeks randomized for PENG block. The unit of randomization will be
the weeks, using random number generation in Microsoft Excel by a statistician who is not
involved in the trial.
Study intervention PENG blocks is performed by Emergency Medicine board-certified emergency
physicians (EPs) with standard training program. PENG block is performed using a spinal
needle (BD® 20G × 90 mm) at the level of of anterior superior iliac spine, parallel to the
inguinal crease, with real-time ultrasound guidance, according to the steps published by
Girón-Arango et al in 2018. The investigators used 20 ml of 1% lidocaine for nerve block
because this drug has a short onset time, which is adequate to relieve pain before surgical
intervention. Regimens of regional anesthesia with a longer duration of action are not
preferred in our department because delayed onset of regional anesthesia particularly impedes
orthopedic assessment in EDs. Dosage of intravenous morphine was determined according to 0.1
mg per kg; EPs were instructed to aim to reduce the pain by 50% or per patient request. They
were encouraged to wait for at least 15 minutes after the study procedure before
administering additional analgesia.
Outcome measures Primary outcome was postdose NRS pain score at rest and with movement. The
NRS for pain with movement was assessed by lifting the affected leg. The examiner assessed
NRS score with movement by gently raising the patient's affected limb about 15 degree by
flexing the hip with the knee in extension. NRS score was assessed as part of standard care
at various timepoints, including at baseline, immediately after the analgesic treatment, at
10, 30, 60, and 120 minutes postdose time points, every 2 h thereafter until discharge from
the ED, and at the time of discharge from the ED and arrival at the orthopedic ward before
surgery.
Secondary outcomes were postdose quadriceps strength, rescue opiate use, complications,
length of ED stay, length of hospital stay, and patient-reported outcomes.
Quadriceps strength was assessed using the knee extension test and Oxford muscle strength
scale. Rescue opioid consumption was measured in morphine milligram equivalents (MME)
administered over all ED visits during the study timeframe. Any complications or side effects
of nerve blocks, including local infection, intravascular injection of local anesthetics and
immediate systemic toxicity, will be recorded. In opioid group, any side effects of opioids
such as drowsiness, desaturation, nausea and vomiting, delirium, or respiratory distress,
will be recorded. Patient-reported outcome defined as patient satisfaction (120 minutes after
initial analgesics, patients were asked whether they would choose the same anesthetic
handling; "yes" or "no").
Sample size calculation and statistical analyses Sample size could not be calculated, as
there is no prior trial on comparison of PENG block and intravenous morphine in patient with
hip fractures. This trial will be a pilot trial. Hence, the investigators intend to recruit
200 participants in total using a 1:1 allocation ratio, with 100 participants randomised into
each arm. Chi-squared test or Fisher's exact test was used for categorical variables, and
Student's t-test was used for continuous variable. Logistic regression was used to analyze
data with dichotomous outcomes; p < 0.05 was considered statistically significant.