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Neurophysiological Monitoring Under TIVANCT05632016

The Impact of ESP on Neurophysiological Monitoring in Scoliotic Patients

A study testing erector spinae block (ESP) in people with Neurophysiological Monitoring Under TIVA, run by Ain Shams University at 1 site in Egypt.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Scoliosis surgery requires intraoperative neuromonitoring. Electrophysiological monitors used include somatosensory evoked potentials (SEPS) and motor-evoked potentials (MEPS). MEPS are a measured muscular contraction produced by stimulation of the motor cortex via electrodes to the scalp. Read more about this study

Who is it for?
Ages 12 to 25 years
Conditions the study is for
Neurophysiological Monitoring Under TIVA
What is being tested?
erector spinae block (ESP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Oct 2022to Mar 2023
Phase
Interventional
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 12 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • patients with American Association of Anesthesiologists up to III physical status undergoing scoliosis repair under TIVA.

Who cannot join

  • Patients with an ASA status above III.
  • patient or guardian refusal to participate, patients with multiple congenital anomalies.
  • hypersensitivity or contraindication to the study drugs.
  • severe restrictive pulmonary disease indicating postoperative ventilation.

Trial locations and contacts

1 site in 1 country.

rehab F abdelrazik, lecturer contact

01110108610 ext. 002

rehab.fattah2002@gmail.com

Egypt1 site, 1 recruiting
  • Ain Shams University Hospital

    Cairo

    Rehab F Abdelfattah Abdelrazik, 00201110108610, rehab.fattah2002@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: The Impact of Erector Spinae Block (ESP)on Neurophysiological Monitoring in Patients Undergoing Scoliosis Repair Under TIVA

Scoliosis surgery requires intraoperative neuromonitoring. Electrophysiological monitors used include somatosensory evoked potentials (SEPS) and motor-evoked potentials (MEPS). MEPS are a measured muscular contraction produced by stimulation of the motor cortex via electrodes to the scalp. Evoked electromyography (EMG) of pedicle screws allows for evaluation of potential injury from incorrect screw placement. Anaesthetic agents: Volatile agents produce dose-related decreases in amplitude of MEPs. MEPs are also stopped with the use of neuromuscular blockade (NMB). It is accepted that an initial dose of a NMB agent will be metabolised before monitoring is required. Therefore a TIVA technique is the recommended anaesthetic technique for this procedure. Propofol has been shown to attenuate MEP signals and should be kept in mind. This effect can be mitigated with the use of Ketamine which increases SEP and MEP amplitudes. Benzodiazepines as well as opioids (including intrathecal opioids) have been shown to have minimal effect on signals. α2 agonists attenuate MEP amplitudes (3).

Accordingly, the goals of spine correction surgery include hemodynamic stability with no interference in neuromonitoring and optimal pain control. Multimodal analgesia is recommended in the preoperative intraoperative and postoperative periods. Intrathecal morphine has been shown to reduce pain scores and allow for improved postoperative analgesia. Remifentanil infusions are used to reduce propofol requirements thus improving neuromonitoring. Hyperalgesia has been noted but various strategies can be used to mitigate this. Intravenous lignocaine and ketamine have been shown to reduce opioid requirements. The use of α2 agonists help to reduce opioid requirements but can attenuate neuromonitoring signals.

Read more

Postoperative administration of extensive amounts of opioids can cause well known side-effects, such as respiratory depression, sedation, pruritis, nausea, vomiting, and constipation. Ileus is also a common complication due to the nature of the surgery and opioid use in the perioperative period. Even with opioids, pain is not always sufficiently managed. Inadequate pain control increases cardiac and respiratory complications, delays mobilization, increases the length of hospital stay and may increase the risk of developing a chronic pain syndrome . The above mentioned complications indicate the need for a novel regional anesthesia techniques. Until recently, regional anesthesia techniques have not been used on a regular basis in spine surgery as an immediate postoperative neurological examination is required. This examination of the motor and sensory function of the spinal cord eliminates spinal and epidural analgesia as suitable pain treatments. Novel interfascial plane blocks, such as the erector spinae plane (ESP) block, generate regional analgesia without interference of spinal cord function and are therefore suitable for spinal surgery pain management .

An ESP block has a very low risk of complications, as sonoanatomy is easily recognizable and there are no structures in close proximity at risk of needle injury. The transverse process acts as an anatomical barrier and avoids needle insertion into the pleura or vessels, thus preventing a pneumothorax or hematoma. Moreover, the needle is relatively far from the vertebral canal, which means the risk of spinal cord injury is very low. It is applied preoperatively before skin incision as a preemptive analgesia so it suppresses chronic sensitization process. In addition, it may abolish the neuroendocrine stress response by decreasing release of the counterregulatory hormones like catecholamines the mechanism by which it may augment controlled hypotensive anaesthesia

Being tested
erector spinae block (ESP)

What participants receive

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

  • erector spinae block (ESP)Procedure or surgery

    the erector spinae plane block will be performed bilaterally using a high-frequency-curved ultrasound transducer (Mindray 35C50EB, China) placed in a longitudinal orientation 3 cm lateral to the spinous process at two different levels, one above the angle of kyphosis at T8- T10 and another below the angle of kyphosis at L3. An 8- cm 22-gauge block needle (EchoStim; Benlan Inc, Oakville, Canada) is inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane below erector spinae muscle, the block will be performed by injection of 10 mL of bupivacaine at each point.A total volume of 40 ml of diluted bupivacaine with a total dose of 3mg/kg with variable concentrations according to body weight will be given for each patient.

Study groups in NCT05632016
Study groupRoleWhat they receive
group NNo interventionpatients will not receive erector spinae block (ESP)
group EActive comparatorpatients will receive bilateral bilevel erector spinae block (ESP)
Receives: Procedure: erector spinae block (ESP)

What is being measured

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

  1. The effect of ESP on neurophysiological monitoring

    the effect of ESP on SSEPs and MEPs during scoliosis repair

    Measured: the whole intraoperative time

Secondary outcomes (1)
  1. Intra and postoperative analgesic effect of ESP

    total dose of intraoperative and postoperative analgesics

    Measured: 24 hours

Timeline

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

  1. First posted30 Nov 2022
  2. Study start1 Oct 2022
  3. Primary completionFeb 2023 (estimated)
  4. Study completionMar 2023 (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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05632016
Sponsor's protocol ID
FMASU R193/2022
Status last verified
Nov 2022
First submitted
20 Nov 2022
Last updated
30 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing erector spinae block (ESP) in people with Neurophysiological Monitoring Under TIVA, run by Ain Shams University at 1 site in Egypt.

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 1 inclusion and 4 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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 rehab F abdelrazik, lecturer (01110108610 ext. 002, rehab.fattah2002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of ESP on neurophysiological monitoring (time frame: the whole intraoperative time). 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 30 Nov 2022.

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