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NCT Number: NCT06721832

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

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

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Key information

Conditions

Cervical Spine Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Benha university

Banhā, ELkalyobia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector spina plane block (ESP)

Procedure

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.

Bupivacain (preoperative)

Drug

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.

Primary outcomes

  1. Visual analogue scale

    Time frame: VAS scores at rest and on passive neck movement postoperatively at 0, 2, 4, 6, 8, 12, 24 and 48 hours

    Visual analogue pain score which scales from zero (no pain) to ten (unbearable pain).

Secondary outcomes

  1. Postoperative Pain Over Time (Visual analogue scale )

    Time frame: Baseline (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.

  2. Diaphragmatic Excursion

    Time frame: Baseline (pre-induction), 30 minutes 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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.

  7. Length of Hospital Stay

    Time frame: 48 hours postoperatively

    Duration of postoperative hospitalization measured in days.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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