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Completed

NCT Number: NCT04974658

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

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.

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Key information

Conditions

Cervical Spine Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Zagazig University, Zagazig, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inter-semispinal plane block

Procedure

Ultrasound Inter-semispinal plane block in block group

Other names: No block intervention in control group

Primary outcomes

  1. Total morphine consumed for 24 hours postoperative will be calculated.

    Time frame: 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 outcomes

  1. Total fentanyl consumed intraoperative will be calculated

    Time frame: 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%.

  2. postoperative pain will be assessed using the Numerical Pain Score (NRS) score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2021
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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