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

Phase 2

Active, not recruiting

• Conditions: Cervical Spine Surgery; Pain Management

• Registration Number: NCT06721832
• Lead Sponsor: Benha University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS	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).
Diaphragmatic excursion	2- Diaphragmatic excursion assessed by ultrasound will be measured at baseline, in PACU 30 minutes after recovery, and 24h postoperative	Diaphragmatic excursion is the movement of the thoracic diaphragm during breathing. Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm. This measures the contraction of the diaphragm. It is performed by asking the patient to exhale and hold it.

Secondary Outcome Measures

Name	Time	Method
morphine intake	During 24 hrs postoperatively	Amount of morphine intake, and time of first rescue analgesic request.

Trial Locations

Locations (1)

Benha university; 🇪🇬 Benha, ELkalyobia, Egypt