The Impact of ESP on Neurophysiological Monitoring in Scoliotic Patients

November 20, 2022 updated by: Ain Shams University

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.

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

Study Overview

Status

Status

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Recruiting

Conditions

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Intervention / Treatment

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Study Type

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Interventional

Enrollment (Anticipated)

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40

Phase

Phase

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  • Not Applicable

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Study Contact

Study Contact

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Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospital
        • Contact:

Participation Criteria

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Eligibility Criteria

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Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: group N
patients will not receive erector spinae block (ESP)
Active Comparator: group E
patients will receive bilateral bilevel erector spinae block (ESP)
Procedure: erector spinae block (ESP)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The effect of ESP on neurophysiological monitoring
Time Frame: the whole intraoperative time
the effect of ESP on SSEPs and MEPs during scoliosis repair
the whole intraoperative time

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intra and postoperative analgesic effect of ESP
Time Frame: 24 hours
total dose of intraoperative and postoperative analgesics
24 hours

Collaborators and Investigators

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Sponsor

Sponsor

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Ain Shams University

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU R193/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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