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PainPhase 4PKNCT05755334

Ropivacaine Pharmacokinetics After Erector Spinae Block

A Phase 4 study testing Ropivacaine in people with Pain and Spinal Fusion, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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%. Read more about this study

Who is it for?
Ages 8 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Spinal Fusion
What is being tested?
Ropivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
1 Jun 2023to 1 Nov 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Patients ≥ 8 year older and > 25 kg undergoing posterior spinal fusion surgery
  • Parents or legal guardians that are fluent in French of English

Who cannot join

  • Patients with any contraindication to locoregional anesthesia
  • Patients that are expected to be intubation for a prolonged period of time after surgery
  • Patients with anemia (hematocrit < 30%) before surgery or at time of the first study blood draw
  • Patients that do not receive an erector spinae plane block
  • Parents or legal Patient/legal guardian that to not consent to participate in the study

Trial locations and contacts

No sites are listed yet.

About this study

Official title: Ropivacaine Pharmacokinetics After Erector Spinae Block in Children Undergoing Posterior Spinal Fusion

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.

Read the detailed 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.

Conditions
Pain, Spinal Fusion
Being tested
Ropivacaine
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05755334
Study groupRoleWhat they receive
Ropivacaine 0.1%Active comparatorErector spinae plane block with 2 ml/kg of ropivacaine 0.1%.
Receives: Drug: Ropivacaine
Ropivacaine 0.2%ExperimentalErector spinae plane block with 1 ml/kg of ropivacaine 0.2%.
Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid Consumption

    Total opioid consumption after surgery

    Measured: 24 hours after surgery

  2. Pain after surgery

    Severity of pain after surgery measured by heart rate variability

    Measured: 24 hours after the surgery

  3. Pain during surgery

    Severity of pain during surgery during measured by heart rate variability

    Measured: During the the surgery

  4. Post-operative Complications

    The number of anesthesia and surgical related complications

    Measured: 24 hours after the surgery

Secondary outcomes (1)
  1. Secondary outcome

    The secondary outcome of this study is defined as the difference in rate in which of ropivacaine 0.1% and ropivacaine 0.2% is absorbed after a spinal block in children undergoing posterior spinal fusion

    Measured: During the and 24 hours after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, single blinded, randomized non-superiority study.
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755334
Sponsor's protocol ID
2023-9498
Acronym
PK
Status last verified
Apr 2023
First submitted
10 Feb 2023
Last updated
14 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine in people with Pain and Spinal Fusion, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gianluca Bertolizio, MD (514 412-4400 ext. 24885, gianluca.bertolizio@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Consumption (time frame: 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.

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