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

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: Completed
• Conditions: Pain Management; Cervical Spine Surgery
• Intervention / Treatment: Procedure: Erector spina plane block (ESP); Drug: Bupivacain (preoperative)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	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

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	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	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	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	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	Duration of postoperative hospitalization measured in days.	48 hours postoperatively
Diaphragmatic Excursion	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 )	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

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Posterior cervical surgery; ESP; PAIN
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Agnosia
• Other Study ID 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