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

Study Overview
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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

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

Conditions
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Cervical Spine Surgery

Intervention / Treatment
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* Procedure: Inter-semispinal plane block


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The block group (ISP)<br>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<br>* Ultrasound Inter-semispinal plane block in block group<br>* Other names: No block intervention in control group;|
| Placebo Comparator: control group (C)<br>No block will be performed | Procedure: Inter-semispinal plane block<br>* Ultrasound Inter-semispinal plane block in block group<br>* Other names: No block intervention in control group;|

What is the study measuring?
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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. |