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

Not Applicable

Completed

• Conditions: Cervical Spine Surgery
• Interventions: Procedure: Inter-semispinal plane block

• Registration Number: NCT04974658
• Lead Sponsor: Zagazig University

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.

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 Timeline

• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-23
• Study Start: 2021-08-10
• Primary Completion: 2022-07-11
• Study Completion: 2022-07-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group (C)	Inter-semispinal plane block	No block will be performed
The block group (ISP)	Inter-semispinal plane block	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.

Primary Outcome Measures

Name	Time	Method
Total morphine consumed for 24 hours postoperative will be calculated.	Total morphine consumed up to 24 hours postoperative	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

Secondary Outcome Measures

Name	Time	Method
Total fentanyl consumed intraoperative will be calculated	total fentanyl dose that will be used for entire operative time.	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%.
postoperative pain will be assessed using the Numerical Pain Score (NRS) score	NRS will be recorded 24 hours postoperative.	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.

Trial Locations

Locations (2)

Faculty of medicine; 🇪🇬 Zagazig, Egypt

Faculty of Medicine, Zagazig University; 🇪🇬 Zagazig, Egypt