Multifidus Cervicis and Inter-Semispinal Plane Blocks in Analgesia After Cervical Spine Surgery

Cervical Spine Surgery Clinical Trial

Official title:

Comparison Between Multifidus Cervicis and Inter-semispinal Plane Blocks in Analgesia After Cervical Spine Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083298
• Other study ID #: 10952//15-8-2023
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Zagazig University
• Contact: Shereen E Abd Ellatif, MD
• Phone: +20552336654
• Email: shosh.again[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Major spine surgery with multilevel instrumentation is followed by a large amount of opioid consumption, significant pain, and difficult mobilization Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesic techniques is of paramount importance. Moreover, early intervention in rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily activity. Effective pain management is one of the crucial components in enhanced recovery after surgery (ERAS).

Numerous regional anesthetic techniques have been used to provide analgesia following cervical spine surgery, including patient-controlled epidural analgesia, cervical paravertebral block, cervical plexus block, cervical erector spinae plane blocks, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for such surgeries.

Up to the author's knowledge, there is no study done to compare multifidus cervicis plane block versus inter-semispinal plane block in a randomized controlled clinical trial as preemptive analgesia in patients undergoing cervical spine surgery.

Description:

Spine surgeries are commonly associated with severe postoperative pain, particularly complex procedures such as laminectomy on more than two disc levels, or scoliosis surgery, especially on the first postoperative day. Spinal foraminal stenosis and disc herniation, occurring often around C5-C7 levels, are the most popular underlying pathologies of the cervical spine.

One of the keys to a patient's recovery following cervical spine surgery is effective postoperative pain management. Nowadays, the concept of pain management with multimodal analgesia and regional anesthesia plays a crucial role in postoperative analgesia reducing opioid consumption and improving early mobilization. Numerous regional anesthetic techniques have been used, including patient-controlled epidural analgesia, cervical paravertebral block, cervical plexus block, cervical erector spinae plane blocks, and local infiltration analgesia. However, some of these techniques have specific limitations that prevent them from being the analgesic technique of choice for cervical spine surgery, and the others are still under research for its effectiveness.

Several new paraspinal blocks have been described in the thoracic and lumbar regions in which the dorsal rami of cervical nerves can be blocked without the block needle entering the paravertebral space. Moreover, novel cervical region blocks, including cervical interfascial plane (CIP) block, multifidus cervicis plane block (MCP), inter-semispinal plane (ISP) block, and retrolaminar cervical block have been developed. All these interfascial plane blocks are considered as promising alternatives to neuraxial blockade for various surgeries.

Multifidus cervicis plane (MCP) block First described by Ohgoshi et al. as a case report for analgesia after cervical laminoplasty, where the local anesthetic was injected between the multifidus cervicis and semispinalis cervicis muscles fascial planes at C5 level. Furthermore, MCP block was effective in another study as a treatment for cervicogenic headaches.

The inter-semispinal plane (ISP) block is also described by Ohgoshi et al., by injecting local anesthetic into the fascial plane between the semispinalis cervicis and capitis muscles and it effectively blocked multiple dorsal rami of the cervical spinal nerves in healthy volunteers.

This study will be designed for evaluation and comparison between Multifidus cervicis and inter-semispinal plane blocks as pre-emptive analgesia for patients undergoing cervical spine surgery under general anesthesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: October 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient acceptance.

• Age 21-60 years old.

• BMI = 30 kg/m2

• ASA I - II.

• Elective posterior cervical spine surgery under general anesthesia.

Exclusion Criteria:

• History of allergy to the LA agents used in this study

• Skin lesion at the needle insertion site,

• Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders

• History of chronic pain and taking analgesics

• History of cognitive dysfunction or mental illness

Related Conditions & MeSH terms

• Cervical Spine Surgery

Intervention

Procedure:
• control group
patients will be operated under general anesthesia
• MCP group
patients will receive ultrasound-guided MCP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.
• ISP group
patients will receive ultrasound-guided ISP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.

Locations

Country	Name	City	State
Egypt	Faculty of medicine, zagazig university	Zagazig	Alsharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023. — View Citation

Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7. — View Citation

Mostafa SF, Abu Elyazed MM, Eid GM, Belal AM. Inter-semispinal plane (ISP) block for postoperative analgesia following cervical spine surgery: A prospective randomized controlled trial. J Clin Anesth. 2022 Dec;83:110974. doi: 10.1016/j.jclinane.2022.110974. Epub 2022 Oct 10. — View Citation

Ohgoshi Y, Izawa H, Kori S, Matsukawa M. Multifidus cervicis plane block is effective for cervical spine surgery. Can J Anaesth. 2017 Mar;64(3):329-330. doi: 10.1007/s12630-016-0767-y. Epub 2016 Nov 3. No abstract available. — View Citation

Ohgoshi Y, Nishizakura R, Takahashi Y, Takeda K, Nakayama H, Kawamata M, Kurahashi K. Novel ultrasound-guided inter-semispinal plane block: a comparative pilot study in healthy volunteers. J Anesth. 2018 Feb;32(1):143-146. doi: 10.1007/s00540-017-2439-7. Epub 2017 Dec 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in Visual analogue scale (VAS)score	On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain	measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively
Secondary	Total dose of rescue analgesia	once the VAS score will be = 3, rescue analgesia in the form of 0.1 mg/kg nalbuphine will be given and the total dose consumed will be recorded	in the first 24 hour postoperatively
Secondary	the first time to rescue analgesia	the time from the end of operation to patient reporting VAS = 3	in the first 24 hour postoperatively