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

NCT06721832 | Completed Phase 3

• 1 other identifier: RC 13-10-2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Management; Cervical Spine Surgery

Keywords

ESP; PAIN; Posterior cervical surgery

Outcome Measures

Primary Outcomes (1)

• 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 0, 2, 4, 6, 8, 12, 24 and 48 hours

Secondary Outcomes (7)

• Postoperative Pain Over Time (Visual analogue scale )

  Baseline (preoperative), 30 minutes, 2, 6, 12, and 48 hours postoperatively

• Diaphragmatic Excursion

  Baseline (pre-induction), 30 minutes after recovery in PACU, and 24 hours postoperatively.

• Opioid Consumption

  Intraoperative period and first 24 hours postoperatively.

• Pulmonary Function

  Baseline (preoperative), 2 hours, and 24 hours postoperatively.

• Patient Satisfaction

  48 hours postoperatively.

Study Arms (2)

Group E

ACTIVE COMPARATOR

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); Drug: Bupivacain (preoperative)

Group C

PLACEBO COMPARATOR

patients will receive a sham block with saline at the corresponding puncture site and same volumes as in group E (sham block) after induction of general anesthesia

Procedure: Erector spina plane block (ESP)

Interventions

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.

Group C; Group E

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.

Group E

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, ELkalyobia, 13511, Egypt

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)