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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Spine Surgery
• Intervention / Treatment: Procedure: Inter-semispinal plane block

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Faculty of medicine, Zagazig university
  • Zagazig, Egypt, 44519
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Inter-semispinal plane block; Ultrasound Inter-semispinal plane block in block group; Other Names: No block intervention in control group
Placebo Comparator: control group (C); No block will be performed	Procedure: Inter-semispinal plane block; Ultrasound Inter-semispinal plane block in block group; Other Names: No block intervention in control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fentanyl consumed intraoperative will be calculated	Total intraoperative fentanyl consumption including the induction doses (1mic/ kg) plus the additional doses of fentanyl (from 0.5 to 1 mic) that will be given if heart rate or blood pressure increases above 20%.	total fentanyl dose that will be used for entire operative time.
postoperative pain will be assessed using the Numerical Pain Score (NRS) score	Numerical Pain Score (NRS) ranges from 0 to 10, where 0 is no pain, and 10 is the worst pain imaginable. Adequate pain control will be considered at Numerical Pain Score (NRS) < 4.	NRS will be recorded 24 hours postoperative.

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Naglaa F Abdelhaleem, MD, Faculty of medicine, Zagazig University Hospitals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: #6955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be available on permission
• IPD Sharing Time Frame: After one year from publishing to a journal
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No