An interventional study of Inter-semispinal plane block in Cervical Spine Surgery, sponsored by Zagazig University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by Zagazig University · Not applicable, Interventional, and Other
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.
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
Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
No block will be performed
Procedure: Inter-semispinal plane block
Ultrasound Inter-semispinal plane block in block group
Also known as: No block intervention in control group
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
Time frame: Total morphine consumed up to 24 hours postoperative
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%.
Time frame: 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.
Time frame: NRS will be recorded 24 hours postoperative.
Plan to share: Yes — Data will be available on permission
Supporting information: Study protocol, Sap
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Zagazig University