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

NCT06083298 | Recruiting

• 1 other identifier: 10952//15-8-2023
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Spine Surgery

Keywords

Multifidus Cervicis plane block; Inter-Semispinal Plane Block; analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total dose of rescue analgesia

  in the first 24 hour postoperatively

• the first time to rescue analgesia

  in the first 24 hour postoperatively

Study Arms (3)

control group

PLACEBO COMPARATOR

patients will be operated under general anesthesia

Procedure: control group

MCP group

ACTIVE COMPARATOR

patients will receive MCP block followed by general anesthesia

Procedure: MCP group

ISP group

ACTIVE COMPARATOR

patients will receive ISP block followed by general anesthesia

Procedure: ISP group

Interventions

control group PROCEDURE

patients will be operated under general anesthesia

control group

MCP group PROCEDURE

patients will receive ultrasound-guided MCP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.

MCP group

ISP group PROCEDURE

patients will receive ultrasound-guided ISP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.

ISP group

Eligibility Criteria

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

You may qualify if:

• Patient acceptance.
• Age 21-60 years old.
• BMI ≤ 30 kg/m2
• ASA I - II.
• Elective posterior cervical spine surgery under general anesthesia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Alsharqia, 4115, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 27812925 BACKGROUND

• 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.

  PMID: 29270836 BACKGROUND

• 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.

  PMID: 36228453 BACKGROUND

• 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.

  PMID: 26149600 BACKGROUND

• 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.

  PMID: 21168100 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Shereen E Abd Ellatif, MD

  Faculty of medicine, zagazig university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shereen E Abd Ellatif, MD

CONTACT

+20552336654; shosh.again@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of anesthesia and surgical intensive care

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 13, 2023
• Study Start: October 20, 2023
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: planned after the completion of the study and publication
• Access Criteria: contact with the principal investigator

Locations

EG (1)