Cervical Spine SurgeryNCT04974658
Analgesic Efficacy of the Novel Intra- Semispinal Fascial Plane Block in Posterior Cervical Spine Surgery
A study testing Inter-semispinal plane block in people with Cervical Spine Surgery, run by Zagazig University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Spine Surgery
- What is being tested?
- Inter-semispinal plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Aug 2021to 11 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Uncooperative patients
- Coagulopathy.
- Local tissue infection.
- Allergy to local anesthesia.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine, Zagazig University
Zagazig, 44519
Faculty of medicine
Zagazig, 44519
About this study
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.
Read the 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
- Conditions
- Cervical Spine Surgery
- Being tested
- Inter-semispinal plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inter-semispinal plane blockProcedure or surgery
Also called No block intervention in control group
Ultrasound Inter-semispinal plane block in block group
| Study group | Role | What they receive |
|---|---|---|
| The block group (ISP) | Active comparator | 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. Receives: Procedure: Inter-semispinal plane block |
| control group (C) | Placebo comparator | No block will be performed Receives: Procedure: Inter-semispinal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Total morphine consumed up to 24 hours postoperative
Secondary outcomes (2)
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%.
Measured: 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.
Measured: NRS will be recorded 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start10 Aug 2021
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Naglaa Fathy Abdelhaleem Abdelhaleem, Zagazig University
- Investigators
- Naglaa F Abdelhaleem, MD, Principal investigator, Faculty of medicine, Zagazig University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974658
- Sponsor's protocol ID
- #6955
- Status last verified
- Dec 2022
- First submitted
- 14 Jul 2021
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on permission
Publications
Ohgoshi Y, Kubo EN. Inter-semispinal plane block for cervical spine surgery. J Clin Anesth. 2018 May;46:94-95. doi: 10.1016/j.jclinane.2018.02.007. Epub 2018 Feb 9. No abstract available.
PubMed 29433034
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of the Novel Intra- Semispinal Fascial Plane Block in Posterior Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT04974658
- Acronym / sponsor ID
- #6955
- Conditions
- Cervical Spine Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The block group (ISP) | Active comparator | Procedure: Inter-semispinal plane blockAfter 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. |
| control group (C) | Placebo comparator | Procedure: Inter-semispinal plane blockNo block will be performed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Uncooperative patients
- Coagulopathy.
- Local tissue infection.
- Allergy to local anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inter-semispinal plane blockAlso: No block intervention in control groupUltrasound Inter-semispinal plane block in block group | Procedure or surgery | The block group (ISP), control group (C) |
Primary outcome
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
2 secondary outcomes
Total fentanyl consumed intraoperative will be calculated
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
Time frame: NRS will be recorded 24 hours postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Background: PubMed 29433034Ohgoshi Y, Kubo EN. Inter-semispinal plane block for cervical spine surgery. J Clin Anesth. 2018 May;46:94-95. doi: 10.1016/j.jclinane.2018.02.007. Epub 2018 Feb 9. No abstract available.
- Individual participant dataSharing planned: Yes. Data will be available on permission
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naglaa F Abdelhaleem, MD principal investigator
Faculty of medicine, Zagazig University Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inter-semispinal plane block in people with Cervical Spine Surgery, run by Zagazig University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumed for 24 hours postoperative will be calculated. (time frame: Total morphine consumed up to 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04974658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.