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

Cervical Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974658
• Other study ID #: #6955
• Status: Completed
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: July 11, 2022

Study information

• Verified date: December 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 11, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spine Surgery

Intervention

Procedure:
• Inter-semispinal plane block
Ultrasound Inter-semispinal plane block in block group

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Zagazig
Egypt	Faculty of Medicine, Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.