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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04974658
Enrollment
52
Registered
2021-07-23
Start date
2021-08-10
Completion date
2022-07-11
Last updated
2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spine Surgery

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

Interventions

PROCEDUREInter-semispinal plane block

Ultrasound Inter-semispinal plane block in block group

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed, and then they are opened by the research anesthesiologist immediately prior to the nerve block.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total morphine consumed for 24 hours postoperative will be calculated.Total morphine consumed up to 24 hours postoperativeCalculation 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

MeasureTime frameDescription
Total fentanyl consumed intraoperative will be calculatedtotal 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) scoreNRS 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026