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

NCT04974658 | Completed

• 1 other identifier: #6955
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cervical Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Total morphine consumed for 24 hours postoperative will be calculated.

  Calculation of total morphine that will be used postoperatively. Postoperative morphine will be considered if the postoperative VAS score \>3 or the patient requested additional analgesia. Rescue analgesia of intravenous morphine will be given

  Total morphine consumed up to 24 hours postoperative

Secondary Outcomes (2)

• Total fentanyl consumed intraoperative will be calculated

  total fentanyl dose that will be used for entire operative time.

• postoperative pain will be assessed using the Numerical Pain Score (NRS) score

  NRS will be recorded 24 hours postoperative.

Study Arms (2)

The block group (ISP)

ACTIVE COMPARATOR

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.

Procedure: Inter-semispinal plane block

control group (C)

PLACEBO COMPARATOR

No block will be performed

Procedure: Inter-semispinal plane block

Interventions

Inter-semispinal plane block PROCEDURE

Ultrasound Inter-semispinal plane block in block group

Also known as: No block intervention in control group

The block group (ISP); control group (C)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncooperative patients
• Coagulopathy.
• Local tissue infection.
• Allergy to local anesthesia.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Faculty of Medicine, Zagazig University

Zagazig, 44519, Egypt

Location

Faculty of medicine

Zagazig, 44519, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29433034 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

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

Study Officials

• Naglaa F Abdelhaleem, MD

  Faculty of medicine, Zagazig University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: August 10, 2021
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After one year from publishing to a journal

Locations

EG (2)