Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05755334 |
| Other study ID # |
2023-9498 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
November 1, 2024 |
Study information
| Verified date |
April 2023 |
| Source |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Contact |
Gianluca Bertolizio, MD |
| Phone |
514 412-4400 |
| Email |
gianluca.bertolizio[@]mcgill.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary aim is to evaluate the analgesic efficacy of either technique by measuring
cumulative morphine consumption in the first 24 hours after an erector spinae plane block
with 2 ml/kg of ropivacaine 0.1% (2 ml/kg) or 1 ml/kg of ropivacaine 0.2%.
The secondary aim of this study is to describe the pharmacokinetics of ropivacaine 0.1% and
ropivacaine 0.2% after erector spinae block in children undergoing posterior spinal fusion.
Description:
Pain is of particular concern in pediatric patients undergoing posterior spinal fusion
surgery. In children, posterior spinal fusion is performed for neuromuscular or adolescent
idiopathic scoliosis. Posterior spinal fusion is highly invasive and entails the fusion of
multiple adjacent vertebral bodies. The surgery generates profound pain from multiple tissue
sources including bones, ligaments, intervertebral discs, nerve root sleeves, fascia and
muscles. In these patients, greater perioperative pain has been shown to increase the risk of
chronicity, prolonged pain medication use, delayed rehabilitation and delayed return of
function. Patients experiencing moderate-to-severe pain in the acute postoperative period
were more likely to report higher levels of pain severity, use more pain medication, and miss
a greater number of school/workdays due to back pain in the last three month.
The mainstream perioperative pain therapy in patients undergoing posterior spinal fusion is
opioid-based. Prolonged intravenous opioids, however, are associate to prolonged length of
stay. As a results, adjuvants of such as acetaminophen, nonsteroidal anti-inflammatory drugs
and ketamine are routinely used in some centers.
Recently, the erector spinae plane (ESP) block has been proposed as an effective adjuvant in
the multimodal analgesia after posterior spinal fusion .
The erector spinae plane block is a paraspinal fascial plane block in which the needle
placement is between the erector spinae muscle and the thoracic transverse processes, and a
local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and
abdominal spinal nerves. This blockage of the dorsal and ventral rami of the spinal nerves
helps to achieve a multi-dermatomal sensory block of the anterior, posterior, and lateral
thoracic and abdominal walls. The erector spinae plane block has been successfully
implemented in the multimodal analgesia management in both adults and children.
However, there is limited information about the pharmacokinetics of ropivacaine after erector
spinae plane blocks. In adults, studies reported potentially neurotoxic plasma concentrations
after the injection of a 'safe" (100 mg) dose of ropivacaine in the transversus plane. In
contrast, in children, plasma concentrations of ropivacaine after
ilioinguinal-iliohypogastric, transversus plane block appear to remain well below the
neurotoxic blood concentration for total ropivacaine (2.2 μg/ml). Similarly, plasma
concentration after erector spinae plane block have been reported to be safe, but data are
limited to a single small investigation. A recent pilot study in children showed high blood
concentrations (0.56 μg/L) of unbound ropivacaine exceeding its potential neurotoxic blood
concentration (0.15 μg/L), but concentrations of total ropivacaine below the neurotoxic (and
cardiovascular) threshold. after erector spinae plane block with ropivacaine at high
concentrations (0.5%).
In 2021, at the Montreal Children's Hospital (MCH) an Enhanced recovery after surgery (ERAS)
protocol for patients undergoing posterior spinal fusion was implemented. This protocol
includes standardized intraoperative anesthesia and postoperative analgesia (Annex 1). At the
end of the surgery, after confirming adequate spinal cord function with the motor and
somatosensory evoked potentials and before skin closure, surgeon injects a 2 mg/kg dose of
the local anesthetic ropivacaine 0.1% (total volume 2 ml/kg) or 0.2% (total volume 1 ml/kg)
in the erector spinae plane.
