Preoperative Block for Anterior Cervical Spine Surgery

NCT ID: NCT06867510

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-08-01

Brief Summary

The purpose of this clinical trial study is to compare the analgesic effects of ultrasound-guided intermediate cervical plexus block Versus cervical erector spinae block in patients undergoing anterior cervical spine surgery.

• The main questions it aims to answer are:

• The primary outcome will be recording postoperative pain intensity using Numerical Rating Scale (NRS).
• The secondary outcomes will be measuring the performance time, onset of the sensory block, intraoperative fentanyl consumption, time to the first call for rescue analgesia (nalbuphine), postoperative total nalbuphine consumption, and postoperative complications such as nausea, vomiting, hypotension, and bradycardia.
• We will compare two blocks to a placebo.
• Participants will:

• undergo ultrasound-guided intermediate cervical plexus block or cervical erector spinae block or a placebo
• Be assessed for pain after 2 h, 4 h, 6 h, 12 h, and 24 h postoperatively

Detailed Description

Anterior cervical spine surgery is a common procedure for treating disc herniation, spinal cord vascular diseases, cervical spondylosis, and tumors. Cervical spine surgery is one of the most painful surgical operations, ranked among the 6 most painful out of 179 assessed surgical procedures, underscoring the challenges in pain management for this patients. Many patients requiring spine surgery are also overweight, have substance use disorders and other comorbidities related to aging.

Surgeons have been able to effectively treat patients with various cervical spine conditions by using specialized retractors, natural muscle planes, and paying careful attention to surrounding structures. However, despite the high success rates associated with these surgeries, patients often experience postoperative pain between the shoulder blades and in the neck.

Improper perioperative pain management after anterior cervical spine surgery can impact a patient's recovery, overall health, ability to swallow, may lead to nausea, vomiting, and chronic pain. Thus, effective pain management techniques are crucial to enhance postoperative care for these patients.

A regional analgesia block is a technique used to suppress nerve transmission and alleviate or prevent pain. It is commonly used in combination with general anesthesia or as the sole anesthetic technique, particularly in plastic, orthopedic and vascular surgeries to reduce the amount of anesthetic and analgesic agents needed, minimize systemic side effects, improve recovery, provide better postoperative pain relief, and shorten hospital stays.

The cervical plexus is made up of the ventral rami of the C1-C4 spinal nerves. The cervical plexus consists of motor (phrenic nerve, direct muscle branches) and terminal sensory branches (C2-C4): the supraclavicular nerves, the lesser occipital nerve, greater auricular nerve, and transverse cervical nerve. The latter is formed in the compartment between the prevertebral and superficial layer of the cervical fascia, deep to the sternocleidomastoid. Before 2004, any cervical plexus blocks that were performed superficially to the prevertebral fascia were termed superficial cervical plexus blocks. However, Telford and Stoneham suggested the term intermediate cervical plexus block to distinguish between the superficial block (subcutaneous or subplatysmal) and the block in the interfascial compartment. Intermediate cervical plexus block is a safe, popular, easy, and effective technique for regional analgesia of cervical region. The use of ultrasound guidance reduces the risk of complications, allows for real-time visualization of anatomical structures, and helps guide needle placement.

Bilateral cervical erector spinae block using ultrasound has recently been studied for shoulder surgery. Since the brachial plexus, phrenic nerves, cervical nerve roots, and deep cervical muscles are enclosed in the prevertebral fascia, injecting a local anesthetic near the cervical transverse process can spread to nearby structures within the prevertebral compartment. In a cadaver study, it was found that injecting a 20 mL dye solution into the transverse process of C6 or C7 resulted in staining of the C5-T1 nerve roots.

With the increasing number of nerve block techniques available, anesthesiologists may have difficulty determining the most appropriate technique to achieve optimal recovery after anterior cervical spine surgery. Therefore, this study will conducted to compare the efficacy of ultrasound-guided intermediate cervical plexus block and cervical erector spinae block in patients undergoing anterior cervical spine surgery.

Conditions

Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intermediate cervical plexus block

The patient will be positioned supine with a slight elevation of the head and the head turned away from the blocked side. After sterilizing the skin, the ultrasound probe will be placed over the middle of the posterior border of the sternocleidomastoid muscle. The needle will be inserted in-plane while keeping the probe in a transverse position. The needle tip will be placed under the sternocleidomastoid muscle and below the superficial fascia, and then, a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side.

Group Type: ACTIVE_COMPARATOR

Block for Anterior Cervical Spine Surgery

Intervention Type: PROCEDURE

The patient will be positioned supine with a slight elevation of the head and the head turned away from the blocked side. After sterilizing the skin, the ultrasound probe will be placed over the middle of the posterior border of the sternocleidomastoid muscle. The needle will be inserted in-plane while keeping the probe in a transverse position. The needle tip will be placed under the sternocleidomastoid muscle and below the superficial fascia, and then, a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side

Cervical Erector spinae block

The patient will be positioned laterally, with a pillow under their head. Transverse ultrasound scanning of the lower cervical area will be done. Starting from the supraclavicular brachial plexus, the transducer will be slid in a cephalic direction to show the transverse process of the C7 vertebra. Then, it will be moved further cephalic to display the transverse process of C6, along with its characteristic anterior and posterior tubercles. The transducer will be then slid posteriorly to show the posterior tubercle of C6, along with the posterior neck muscles above it (trapezius, levator scapula, and erector spinae). After prepping and draping the patient using aseptic technique, the needle will be inserted (in plane technique from posterior) until it will reach the posterior tubercle of C6. Then, a total volume of 15 ml of bupivacaine 0.25% will be injected bilaterally. The same steps will be repeated on the opposite side.

Group Type: ACTIVE_COMPARATOR

Block for Anterior Cervical Spine Surgery

Intervention Type: PROCEDURE

The patient will be positioned supine with a slight elevation of the head and the head turned away from the blocked side. After sterilizing the skin, the ultrasound probe will be placed over the middle of the posterior border of the sternocleidomastoid muscle. The needle will be inserted in-plane while keeping the probe in a transverse position. The needle tip will be placed under the sternocleidomastoid muscle and below the superficial fascia, and then, a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side

Control group

Total volume of 15 ml of saline 0.9% will be injected subcutaneous bilaterally

Group Type: PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type: DRUG

Total volume of 15 ml of saline 0.9% will be injected subcutaneous bilaterally

Interventions

Block for Anterior Cervical Spine Surgery

The patient will be positioned supine with a slight elevation of the head and the head turned away from the blocked side. After sterilizing the skin, the ultrasound probe will be placed over the middle of the posterior border of the sternocleidomastoid muscle. The needle will be inserted in-plane while keeping the probe in a transverse position. The needle tip will be placed under the sternocleidomastoid muscle and below the superficial fascia, and then, a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side

Intervention Type: PROCEDURE

Saline (NaCl 0,9 %) (placebo)

Total volume of 15 ml of saline 0.9% will be injected subcutaneous bilaterally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Both sex
• Age: between 21 and 60 years
• Physical status: belongs to American Society of Anesthesiologists (ASA) I, II
• Body mass index (BMI): from 25 to 30 kg/m2
• Type of surgery: elective anterior cervical spine surgery under general anesthesia

Exclusion Criteria

• Refusal of participation.
• local infection at the puncture site.
• Mental or physical disability.
• History of allergy to study drugs (bupivacaine, fentanyl).
• Hematological disorders including coagulation abnormalities.
• Severe hepatic or kidney impairment.
• Chronic pain.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abd Elfatah khodair

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Teaching Hospital

Tanta, Qism Awwal Tanta, Egypt

Countries

Egypt

Central Contacts

mohammed A khodair, master

Role: CONTACT

khodair1993@gmail.com

+201004881505

Nadea H Fetouh, Professor

Role: CONTACT

nadia.fatouh@med.tanta.edu.eg

+201222832463

Facility Contacts

Role: primary

edu_hospital@unv.tanta.edu.eg

+20403339058

References

Kamel AAF, Fahmy AM, Fathi HM, Elmesallamy WAEA, Khalifa OYA. Regional analgesia using ultrasound-guided intermediate cervical plexus block versus cervical erector spinae block for anterior cervical spine surgery: a randomized trial. BMC Anesthesiol. 2024 Apr 22;24(1):153. doi: 10.1186/s12871-024-02533-6.

Reference Type: RESULT

PMID: 38649826 (View on PubMed)

Abdelhaleem NF, Youssef EM, Hegab AS. Analgesic efficacy of inter-semispinal fascial plane block in Patients undergoing Cervical Spine Surgery through Posterior Approach: a randomized controlled trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101213. doi: 10.1016/j.accpm.2023.101213. Epub 2023 Mar 7.

Reference Type: RESULT

PMID: 36894055 (View on PubMed)

Related Links

https://doi.org/10.1186/s12871-024-02533-6

Related Info

Other Identifiers

Block in Spine Surgery

Identifier Type: -

Identifier Source: org_study_id