Preoperative Block for Anterior Cervical Spine Surgery

NCT06867510 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: Block in Spine Surgery
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia, Local

Keywords

Regional anesthesia in cervical spine surgery

Outcome Measures

Primary Outcomes (1)

• change in postoperative pain intensity using Numerical Rating Scale

  Numeric Rating Scale ( NRS) score, a commonly used 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme ( pain as bad as you can imagine or worst pain imaginable). The patient will be instructed to mark along the line to represent the intensity of pain currently being experienced.

  (Day 1) 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperative

Secondary Outcomes (3)

• Change in the time of performance of the technique in minutes.

  Perioperative/Periprocedural

• Change in the time to the first call for analgesia (nalbuphine) in hours.

  Perioperative/Periprocedural

• The total measure of nalbuphine given to each patient during the first 24 hours of the postoperative period

  Perioperative/Periprocedural

Study Arms (3)

Intermediate cervical plexus block

ACTIVE COMPARATOR

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.

Procedure: Block for Anterior Cervical Spine Surgery

Cervical Erector spinae block

ACTIVE COMPARATOR

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.

Procedure: Block for Anterior Cervical Spine Surgery

Control group

PLACEBO COMPARATOR

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

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Block for Anterior Cervical Spine Surgery 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; Intermediate cervical plexus block

Saline (NaCl 0,9 %) (placebo) DRUG

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

Control group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Teaching Hospital

Tanta, Qism Awwal Tanta, 31111, Egypt

Location

Related Publications (2)

• 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.

  PMID: 38649826 RESULT

• 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.

  PMID: 36894055 RESULT

Related Links

• Related Info

MeSH Terms

Interventions

Dental Occlusion; Sodium Chloride

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

mohammed A khodair, master

CONTACT

+201004881505; khodair1993@gmail.com

Nadea H Fetouh, Professor

CONTACT

+201222832463; nadia.fatouh@med.tanta.edu.eg

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: Assistant lecturer

Model Details: All blocks will be conducted under sterile conditions in the operating room with sedation "midazolam 0.03-0.05 mg/kg as needed" 30 minutes before induction of general anesthesia. 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

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 10, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)