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RecruitingNCT06083298Updated Jul 17, 2025

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

An interventional study of control group and MCP group in Cervical Spine Surgery, sponsored by Zagazig University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-17.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Cervical Spine Surgery

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Keywords

  • Multifidus Cervicis plane block
  • Inter-Semispinal Plane Block
  • analgesia
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's planned enrollment of 105 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
105 participants (estimated)

Study arms

  • Placebo comparator
    control group

    patients will be operated under general anesthesia

    Procedure: control group

  • Active comparator
    MCP group

    patients will receive MCP block followed by general anesthesia

    Procedure: MCP group

  • Active comparator
    ISP group

    patients will receive ISP block followed by general anesthesia

    Procedure: ISP group

Interventions

  • Procedurecontrol group

    patients will be operated under general anesthesia

  • ProcedureMCP group

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

  • ProcedureISP group

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

06

What researchers measure

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

    Time frame: measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively

Secondary outcomes

  1. 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

    Time frame: in the first 24 hour postoperatively

  2. the first time to rescue analgesia

    the time from the end of operation to patient reporting VAS ≥ 3

    Time frame: in the first 24 hour postoperatively

07

Study locations

1 of 1 sites recruiting
  • Faculty of medicine, zagazig university
    Zagazig, Alsharqia 4115, Egypt
    • Shereen E Abd Ellatif, MD · Contact · shosh.again@gmail.com · +20552336654
    • Shereen E Abd Ellatif, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27812925 ↗
  • 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. PubMed 29270836 ↗
  • 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. PubMed 36228453 ↗
  • 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. PubMed 26149600 ↗
  • 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. PubMed 21168100 ↗

Individual participant data

Plan to share: Yes — planned after the completion of the study and publication

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06083298
Lead sponsor
Zagazig University
Responsible party
Shereen Elsayed Abd Ellatif (associate professor of anesthesia and surgical intensive care, Zagazig University) — Principal investigator
First posted
Oct 13, 2023
Start date
Oct 20, 2023
Primary completion
Mar 1, 2026 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Jul 17, 2025

Study contacts

Shereen E Abd Ellatif, MD
Contact
shosh.again@gmail.com
+20552336654 ext. 002
Shereen E Abd Ellatif, MD
principal investigator · Faculty of medicine, zagazig university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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