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Analgesic Efficacy of the Novel Intra- Semispinal Fascial Plane Block in Posterior Cervical Spine Surgery

NCT ID: NCT04974658

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-10

Study Completion Date

2022-07-11

Brief Summary

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Posterior cervical spine surgery often requires a large posterior midline incision, resulting in poorly controlled postoperative pain, which arises from iatrogenic mechanical damage, intraoperative retraction, and resection to structures such as bone, ligaments, muscles, intervertebral discs, and zygapophysial joints.

Detailed Description

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Ultrasound-guided Inter-semispinal plane (ISP) block, was proposed as a novel technique for analgesia in posterior cervical spine surgeries. The ISP block involves an injection of local anesthetic into the fascial plane between the semispinalis cervicis and semispinal capitis muscles and results in blocking the dorsal rami of the cervical spinal nerves. ISP block can provide effective analgesia in posterior cervical spine surgery

Conditions

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Cervical Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be performed in neurosurgical operating rooms at Zagazig University Hospitals and included 52 patients allocated randomly into two groups: 26 patients recruited in the block group (I) for the Inter-semispinal plane block and 26 patients recruited in the (C) control group.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed, and then they are opened by the research anesthesiologist immediately prior to the nerve block.

Study Groups

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The block group (ISP)

After aseptic preparation of the injection area, the needle will be introduced in-plane through the skin and advanced into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles. After negative aspiration for blood, 20 ml of 0.25% bupivacaine on each side will be injected for each block.

Group Type ACTIVE_COMPARATOR

Inter-semispinal plane block

Intervention Type PROCEDURE

Ultrasound Inter-semispinal plane block in block group

control group (C)

No block will be performed

Group Type PLACEBO_COMPARATOR

Inter-semispinal plane block

Intervention Type PROCEDURE

Ultrasound Inter-semispinal plane block in block group

Interventions

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Inter-semispinal plane block

Ultrasound Inter-semispinal plane block in block group

Intervention Type PROCEDURE

Other Intervention Names

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No block intervention in control group

Eligibility Criteria

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Inclusion Criteria

* Patients' acceptance.
* ASA I , II andIII .
* Age between 18 years up to 70 years in both sexes.
* Patients with a BMI (body mass index) ranging from 18.5 to 30 kg/m2.
* Patients who scheduled for elective posterior cervical spine surgeries

Exclusion Criteria

* Uncooperative patients
* Coagulopathy.
* Local tissue infection.
* Allergy to local anesthesia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Naglaa Fathy Abdelhaleem Abdelhaleem

Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naglaa F Abdelhaleem, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, Zagazig University Hospitals

Locations

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Faculty of Medicine, Zagazig University

Zagazig, , Egypt

Site Status

Faculty of medicine

Zagazig, , Egypt

Site Status

Countries

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Egypt

References

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Ohgoshi Y, Kubo EN. Inter-semispinal plane block for cervical spine surgery. J Clin Anesth. 2018 May;46:94-95. doi: 10.1016/j.jclinane.2018.02.007. Epub 2018 Feb 9. No abstract available.

Reference Type BACKGROUND
PMID: 29433034 (View on PubMed)

Other Identifiers

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#6955

Identifier Type: -

Identifier Source: org_study_id