The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery

August 28, 2026 updated by: Fatma Ahmed Abdel Fatah, Benha University

The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery: a Randomized Controlled Trial

Posterior cervical spine surgery, often performed on older individuals with significant comorbidities, is one of the most painful surgical operations. Anesthesiologists face a unique challenge in managing pain following these surgeries,Erector spinae plane block (ESPB) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016.Cervical erector spinae plane (ESP) block has been described to anesthetize the brachial plexus (BP), however, the mechanism of its clinical effect remains unknown. As the prevertebral fascia encloses the phrenic nerves, BP and erector spinae muscles to form a prevertebral compartment, a local anesthetic injected in the cervical ESP could potentially spread throughout the prevertebral compartment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • ELkalyobia
      • Banhā, ELkalyobia, Egypt, 13511
        • Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (ASA )classes I and II
  • patients of either sex
  • above the age of 18 who will undergo posterior cervical surgery

Exclusion Criteria:

  • patient's refusal to participate
  • any contraindications to peripheral nerve blocks
  • history of ischemic heart disease
  • patients on opioids for chronic pain
  • patients with significant cognitive impairment

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: Treatment
  • 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.
Active Comparator: Group E
patients will receive bilateral in-plane ultrasound guided erector spinea plane block with 30 ml of bupivacaine 0. 25% (15 ml in each side) after induction of general anesthesia
Procedure: Erector spina plane block (ESP)
The block will be performed in prone position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") T1 transverse process will be approached with an 18 G Tuohy's needle in caudal-to-cranial direction. A total of 30 ml of 0.25% bupivacaine was administered deep to erector spinae muscle (ESM) bilaterally.
Drug: Bupivacain (preoperative)
The block will be performed in prone position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") T1 transverse process will be approached with an 18 G Tuohy's needle in caudal-to-cranial direction. A total of 30 ml of 0.25% bupivacaine was administered deep to erector spinae muscle (ESM) bilaterally.
Placebo Comparator: Group C
patients will receive a sham block with 2 ml saline injected subcutaneously (sham block) after induction of general anesthesia
Procedure: Erector spina plane block (ESP)
The block will be performed in prone position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") T1 transverse process will be approached with an 18 G Tuohy's needle in caudal-to-cranial direction. A total of 30 ml of 0.25% bupivacaine was administered deep to erector spinae muscle (ESM) bilaterally.

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
Visual analogue scale
Time Frame: VAS scores at rest and on passive neck movement postoperatively at 24 hours
Visual analogue pain score which scales from zero (no pain) to ten (unbearable pain).
VAS scores at rest and on passive neck movement postoperatively at 24 hours

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
Opioid Consumption
Time Frame: Intraoperative period and first 24 hours postoperatively.
Total intraoperative fentanyl consumption and cumulative morphine consumption during the first 24 postoperative hours. Time to first rescue analgesic request will also be recorded.
Intraoperative period and first 24 hours postoperatively.
Pulmonary Function
Time Frame: Baseline (preoperative), 2 hours, and 24 hours postoperatively.
Pulmonary function will be assessed using spirometry to record forced vital capacity (FVC) and forced expiratory volume in one second (FEV₁).
Baseline (preoperative), 2 hours, and 24 hours postoperatively.
Patient Satisfaction
Time Frame: 48 hours postoperatively.
Patient satisfaction with postoperative analgesia will be evaluated using a 5-point Likert scale (1 = very unsatisfied, 5 = very satisfied).
48 hours postoperatively.
Block-Related Adverse Events
Time Frame: 48 hours post-operatively
Incidence of block-related adverse events, including desaturation, dyspnea, local anesthetic systemic toxicity, hematoma, or nerve injury.
48 hours post-operatively
Length of Hospital Stay
Time Frame: 48 hours postoperatively
Duration of postoperative hospitalization measured in days.
48 hours postoperatively
Diaphragmatic Excursion
Time Frame: Baseline (pre-induction), 2 hours after recovery in PACU, and 24 hours postoperatively.
Diaphragmatic excursion will be measured using B-mode and M-mode ultrasonography during quiet breathing. Excursion is defined as the craniocaudal displacement of the diaphragm dome during tidal respiration.
Baseline (pre-induction), 2 hours after recovery in PACU, and 24 hours postoperatively.
Postoperative Pain Over Time (Visual analogue scale )
Time Frame: preoperative ,30 minutes, 2,6,12 and 48 hours postoperatively
VAS pain scores at rest will be recorded at predefined postoperative intervals to evaluate pain trajectory.
preoperative ,30 minutes, 2,6,12 and 48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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.
January 1, 2025

Primary Completion (Actual)

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.
May 1, 2025

Study Completion (Actual)

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.
June 1, 2025

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 28, 2024

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.
December 3, 2024

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.
December 6, 2024

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.
September 1, 2026

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.
August 28, 2026

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.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • RC 13-10-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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