Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02056288 |
| Other study ID # |
H-27386 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2011 |
| Est. completion date |
March 1, 2019 |
Study information
| Verified date |
May 2021 |
| Source |
Baylor College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study compares nerve blocks to IV pain medicines in children with broken arms. We are
trying to see if blocking the nerves in the broken arm results in better pain control and
less side effects than injections of morphine into a vein after surgery for a broken elbow.
Description:
Written consent will be obtained by the investigators prior to the surgical procedure using
the Institutional Review Board (IRB) approved consent form. The medical record will be
examined and the use of any analgesic medications in the 24 hours prior to the procedure will
be recorded. Patients will be taken to the OR and anesthetized using standard procedures of
the Texas Children's Hospital (TCH) department of anesthesia, including monitoring according
to the American Society of Anesthesiologists guidelines (EKG, pulse oximetry, BP, temperature
and end-tidal expired carbon dioxide and inhalation anesthetic gases). If the Attending
Anesthesiologist believes the child is at risk for aspiration of gastric contents, a rapid
sequence induction with propofol 3-4 mg/kg and succinylcholine 1mg/kg IV will be performed
with cricoid pressure, in keeping with standard practices. In other patients an IV will be
started after induction of anesthesia. An age appropriate endotracheal tube or appropriate
sized laryngeal mask airway (LMA) will be inserted in all patients. Anesthesia will be
maintained with sevoflurane, nitrous oxide and oxygen, adjusted to keep blood pressure and
heart rate within 20% of baseline values, in keeping with standard practices. All patients
will receive ketorolac 0.5mg/kg IV.
Patients will be randomized in a 1:1 ratio into one of two study groups: ultrasound guided
supraclavicular block or IV opioids, based on a computer generated random number by using
Random Allocation Software For Parallel Group Randomized Trials. The assignment will be made
only after written informed consent has been obtained. There will be an equal chance a child
will be assigned to one of the two groups. Patients randomized to the systemic analgesia
group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the
supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg
ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order
to decrease variance in success rates, the ultrasound guided nerve block will be performed by
1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100
ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher
frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular
fossa. The brachial plexus will be identified as a cluster of hypoechoic nodules, lateral to
the round pulsating hypoechoic subclavian artery and lying on top of the hyperechoic first
rib. The cupola of the lung will be identified. If the transverse colli artery is visualized
cephalically surrounding the plexus, the probe will be moved toward a better coronal oblique
plane, directing the ultrasound beam slightly caudally, in order to keep the artery away from
the plexus. The needle will be was carefully introduced using an in-plane (IP) technique from
lateral to medial, toward but not into the brachial plexus. The entire needle image will be
visualised at all times to ensure it does not enter the vessel, nerve plexus or pleura. The
spread of local anesthetic to all targets of the plexus will be observed on the ultrasound
image.
The time taken to place the block will be recorded from the time the ultrasound probe is
first placed on the child until completion of local anesthetic injection. The observer
collecting postoperative data will not be present when the block is placed, and a band-aid
will be placed over the supraclavicular fossa in all patients to maintain blinding of the
observer to the group assignment. During the operation patients can receive intraoperative
fentanyl, 1 mcg/kg IV at a time, if the attending anesthesiologist believes it is clinically
indicated. At the end of the operation, anesthetic gases will be discontinued while the
patient breathes 100% oxygen. The trachea will be extubated when the patient responds to
commands, and the child will then be taken to the Post Anesthetic Care Unit (PACU) in keeping
with standard practices . A validated pain scale (verbal rating scale where 0 = no pain and
10 = worst possible pain ever) will be used throughout to assess the severity of pain in the
postoperative period. In keeping with current practice, patients with pain scores>4 will be
treated with morphine 0.05mg/kg IV at 10 minute intervals until the score is below 4. Oral
acetaminophen with hydrocodone (Lortab elixir 0.15mg/kg hydrocodone) will be administered to
children for pain scores between 2- 3. Supplemental oxygen, rescue antiemetic and
antipruritic drugs will be administered in keeping with standard practices of TCH and the
clinical judgment of the Attending Anesthesiologist. The duration of supplemental oxygen
therapy, any medication administered and complications (side effects such as nausea,
vomiting, itching, respiratory depression, prolonged awakening) will be recorded on the case
report form.
The blinded observer will record pain scores within 15 minutes of arrival in the PACU and at
30 minutes, 1,2,6,12,24, and 48 hours after arrival in the PACU. If the child is sleeping at
this time, the scores will be recorded when awake. Prior to discharge home, parents will be
educated on use of the 0-10 pain scale and given a diary to keep an accurate record of
postoperative pain issues through the study period. The goal is to capture maximum pain
scores at rest and with movement. Patient and parental satisfaction with pain management and
with the global perioperative experience will also be graded on a numeric scale 0-10 scale.
Time to readiness for discharge will also be measured from the time the patient enters the
PACU to when the patient attains an Aldrete score of 9-10. This is a standardized scale used
to assess discharge readiness at TCH and is listed below:
Aldrete Scoring System Activity Can move voluntarily or on command 4 extremities 2 2
extremities 1 0 extremities 0 Respiration Can deep-breathe and cough freely 2 Dyspnea,
shallow or limited breathing 1 Apneic 0 Circulation Preoperative BP (mmHg) BP ± 20 mmHg of
baseline 2 BP ± 20-50 mmHg of baseline 1 BP ± 20 mmHg 0 Consciousness Fully Awake 2 Arousable
on calling 1 Not responding 0 Color Normal 2 Pale, dusky, blotchy 1 Cyanotic 0 Score of 10:
ready for discharge
If the patient is discharged before the end of a 48 hour period after surgery, they will be
given a diary to complete to list all medications given, and to assess their pain at various
time intervals (12,24, 48 hours after surgery), along with their satisfaction with pain
control. The patient will be contacted after discharge to obtain the data in the diary. Phone
calls will also be placed on Post- operative Day (POD) #1,2, & 3 to the family following to
assess measured endpoints (pain, medication usage, satisfaction, resolution of nerve block).
At the time of their follow up visit to the surgeon, a complete physical examination will be
done including a neurological evaluation for any nerve injury.
