Cervical Spine SurgeryNCT06083298
Multifidus Cervicis and Inter-Semispinal Plane Blocks in Analgesia After Cervical Spine Surgery
A study testing MCP group and ISP group in people with Cervical Spine Surgery, run by Zagazig University at 1 site in Egypt.
Trial summary
Major spine surgery with multilevel instrumentation is followed by a large amount of opioid consumption, significant pain, and difficult mobilization Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Cervical Spine Surgery
- What is being tested?
- MCP group and ISP group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient acceptance.
- Age 21-60 years old.
- BMI ≤ 30 kg/m2
- ASA I - II.
- Elective posterior cervical spine surgery under general anesthesia.
Who cannot join
- History of allergy to the LA agents used in this study
- Skin lesion at the needle insertion site,
- Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
- History of chronic pain and taking analgesics
- History of cognitive dysfunction or mental illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, zagazig university
Zagazig, Alsharqia, 4115
Shereen E Abd Ellatif, MD, +20552336654 ext. 002, shosh.again@gmail.com
Shereen E Abd Ellatif, MD
About this study
Official title: Comparison Between Multifidus Cervicis and Inter-semispinal Plane Blocks in Analgesia After Cervical Spine Surgery: A Randomized Controlled Trial
Major spine surgery with multilevel instrumentation is followed by a large amount of opioid consumption, significant pain, and difficult mobilization Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesic techniques is of paramount importance. Moreover, early intervention in rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily activity. Effective pain management is one of the crucial components in enhanced recovery after surgery (ERAS).
Numerous regional anesthetic techniques have been used to provide analgesia following cervical spine surgery, including patient-controlled epidural analgesia, cervical paravertebral block, cervical plexus block, cervical erector spinae plane blocks, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for such surgeries.
Up to the author's knowledge, there is no study done to compare multifidus cervicis plane block versus inter-semispinal plane block in a randomized controlled clinical trial as preemptive analgesia in patients undergoing cervical spine surgery.
Read the detailed description
Spine surgeries are commonly associated with severe postoperative pain, particularly complex procedures such as laminectomy on more than two disc levels, or scoliosis surgery, especially on the first postoperative day. Spinal foraminal stenosis and disc herniation, occurring often around C5-C7 levels, are the most popular underlying pathologies of the cervical spine.
One of the keys to a patient's recovery following cervical spine surgery is effective postoperative pain management. Nowadays, the concept of pain management with multimodal analgesia and regional anesthesia plays a crucial role in postoperative analgesia reducing opioid consumption and improving early mobilization. Numerous regional anesthetic techniques have been used, including patient-controlled epidural analgesia, cervical paravertebral block, cervical plexus block, cervical erector spinae plane blocks, and local infiltration analgesia. However, some of these techniques have specific limitations that prevent them from being the analgesic technique of choice for cervical spine surgery, and the others are still under research for its effectiveness.
Several new paraspinal blocks have been described in the thoracic and lumbar regions in which the dorsal rami of cervical nerves can be blocked without the block needle entering the paravertebral space. Moreover, novel cervical region blocks, including cervical interfascial plane (CIP) block, multifidus cervicis plane block (MCP), inter-semispinal plane (ISP) block, and retrolaminar cervical block have been developed. All these interfascial plane blocks are considered as promising alternatives to neuraxial blockade for various surgeries.
Multifidus cervicis plane (MCP) block First described by Ohgoshi et al. as a case report for analgesia after cervical laminoplasty, where the local anesthetic was injected between the multifidus cervicis and semispinalis cervicis muscles fascial planes at C5 level. Furthermore, MCP block was effective in another study as a treatment for cervicogenic headaches.
The inter-semispinal plane (ISP) block is also described by Ohgoshi et al., by injecting local anesthetic into the fascial plane between the semispinalis cervicis and capitis muscles and it effectively blocked multiple dorsal rami of the cervical spinal nerves in healthy volunteers.
This study will be designed for evaluation and comparison between Multifidus cervicis and inter-semispinal plane blocks as pre-emptive analgesia for patients undergoing cervical spine surgery under general anesthesia.
- Conditions
- Cervical Spine Surgery
- Being tested
- control group, MCP group, ISP group
- Keywords
- Multifidus Cervicis plane block, Inter-Semispinal Plane Block, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupProcedure or surgery
patients will be operated under general anesthesia
MCP groupProcedure or surgery
patients will receive ultrasound-guided MCP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.
ISP groupProcedure or surgery
patients will receive ultrasound-guided ISP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | patients will be operated under general anesthesia Receives: Procedure: control group |
| MCP group | Active comparator | patients will receive MCP block followed by general anesthesia Receives: Procedure: MCP group |
| ISP group | Active comparator | patients will receive ISP block followed by general anesthesia Receives: Procedure: ISP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Visual analogue scale (VAS)score
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain
Measured: measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively
Secondary outcomes (2)
Total dose of rescue analgesia
once the VAS score will be ≥ 3, rescue analgesia in the form of 0.1 mg/kg nalbuphine will be given and the total dose consumed will be recorded
Measured: in the first 24 hour postoperatively
the first time to rescue analgesia
the time from the end of operation to patient reporting VAS ≥ 3
Measured: in the first 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start20 Oct 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shereen Elsayed Abd Ellatif, Zagazig University
- Investigators
- Shereen E Abd Ellatif, MD, Principal investigator, Faculty of medicine, zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083298
- Sponsor's protocol ID
- 10952//15-8-2023
- Status last verified
- Jul 2025
- First submitted
- 8 Oct 2023
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Ohgoshi Y, Izawa H, Kori S, Matsukawa M. Multifidus cervicis plane block is effective for cervical spine surgery. Can J Anaesth. 2017 Mar;64(3):329-330. doi: 10.1007/s12630-016-0767-y. Epub 2016 Nov 3. No abstract available.
PubMed 27812925Ohgoshi Y, Nishizakura R, Takahashi Y, Takeda K, Nakayama H, Kawamata M, Kurahashi K. Novel ultrasound-guided inter-semispinal plane block: a comparative pilot study in healthy volunteers. J Anesth. 2018 Feb;32(1):143-146. doi: 10.1007/s00540-017-2439-7. Epub 2017 Dec 21.
PubMed 29270836Mostafa SF, Abu Elyazed MM, Eid GM, Belal AM. Inter-semispinal plane (ISP) block for postoperative analgesia following cervical spine surgery: A prospective randomized controlled trial. J Clin Anesth. 2022 Dec;83:110974. doi: 10.1016/j.jclinane.2022.110974. Epub 2022 Oct 10.
PubMed 36228453Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
PubMed 26149600Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023.
PubMed 21168100
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Multifidus Cervicis and Inter-semispinal Plane Blocks in Analgesia After Cervical Spine Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06083298
- Acronym / sponsor ID
- 10952//15-8-2023
- Conditions
- Cervical Spine Surgery
- Keywords
- Multifidus Cervicis plane block, Inter-Semispinal Plane Block, analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 13 Oct 2023 (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.
Major spine surgery with multilevel instrumentation is followed by a large amount of opioid consumption, significant pain, and difficult mobilization Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesic techniques is of paramount importance. Moreover, early intervention in rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily activity. Effective pain management is one of the crucial components in enhanced recovery after surgery (ERAS).
Numerous regional anesthetic techniques have been used to provide analgesia following cervical spine surgery, including patient-controlled epidural analgesia, cervical paravertebral block, cervical plexus block, cervical erector spinae plane blocks, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for such surgeries.
Up to the author's knowledge, there is no study done to compare multifidus cervicis plane block versus inter-semispinal plane block in a randomized controlled clinical trial as preemptive analgesia in patients undergoing cervical spine surgery.
Detailed description
Spine surgeries are commonly associated with severe postoperative pain, particularly complex procedures such as laminectomy on more than two disc levels, or scoliosis surgery, especially on the first postoperative day. Spinal foraminal stenosis and disc herniation, occurring often around C5-C7 levels, are the most popular underlying pathologies of the cervical spine.
One of the keys to a patient's recovery following cervical spine surgery is effective postoperative pain management. Nowadays, the concept of pain management with multimodal analgesia and regional anesthesia plays a crucial role in postoperative analgesia reducing opioid consumption and improving early mobilization. Numerous regional anesthetic techniques have been used, including patient-controlled epidural analgesia, cervical paravertebral block, cervical plexus block, cervical erector spinae plane blocks, and local infiltration analgesia. However, some of these techniques have specific limitations that prevent them from being the analgesic technique of choice for cervical spine surgery, and the others are still under research for its effectiveness.
Several new paraspinal blocks have been described in the thoracic and lumbar regions in which the dorsal rami of cervical nerves can be blocked without the block needle entering the paravertebral space. Moreover, novel cervical region blocks, including cervical interfascial plane (CIP) block, multifidus cervicis plane block (MCP), inter-semispinal plane (ISP) block, and retrolaminar cervical block have been developed. All these interfascial plane blocks are considered as promising alternatives to neuraxial blockade for various surgeries.
Multifidus cervicis plane (MCP) block First described by Ohgoshi et al. as a case report for analgesia after cervical laminoplasty, where the local anesthetic was injected between the multifidus cervicis and semispinalis cervicis muscles fascial planes at C5 level. Furthermore, MCP block was effective in another study as a treatment for cervicogenic headaches.
The inter-semispinal plane (ISP) block is also described by Ohgoshi et al., by injecting local anesthetic into the fascial plane between the semispinalis cervicis and capitis muscles and it effectively blocked multiple dorsal rami of the cervical spinal nerves in healthy volunteers.
This study will be designed for evaluation and comparison between Multifidus cervicis and inter-semispinal plane blocks as pre-emptive analgesia for patients undergoing cervical spine surgery under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Procedure: control grouppatients will be operated under general anesthesia |
| MCP group | Active comparator | Procedure: MCP grouppatients will receive MCP block followed by general anesthesia |
| ISP group | Active comparator | Procedure: ISP grouppatients will receive ISP block followed by general anesthesia |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient acceptance.
Key exclusion criteria (5 listed)
- History of allergy to the LA agents used in this study
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 |
|---|---|---|
| control grouppatients will be operated under general anesthesia | Procedure or surgery | control group |
| MCP grouppatients will receive ultrasound-guided MCP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia. | Procedure or surgery | MCP group |
| ISP grouppatients will receive ultrasound-guided ISP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia. | Procedure or surgery | ISP group |
Primary outcome
changes in Visual analogue scale (VAS)score
Time frame: measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain
2 secondary outcomes
Total dose of rescue analgesia
Time frame: in the first 24 hour postoperatively
the first time to rescue analgesia
Time frame: in the first 24 hour postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 27812925Ohgoshi Y, Izawa H, Kori S, Matsukawa M. Multifidus cervicis plane block is effective for cervical spine surgery. Can J Anaesth. 2017 Mar;64(3):329-330. doi: 10.1007/s12630-016-0767-y. Epub 2016 Nov 3. No abstract available.
- Background: PubMed 29270836Ohgoshi Y, Nishizakura R, Takahashi Y, Takeda K, Nakayama H, Kawamata M, Kurahashi K. Novel ultrasound-guided inter-semispinal plane block: a comparative pilot study in healthy volunteers. J Anesth. 2018 Feb;32(1):143-146. doi: 10.1007/s00540-017-2439-7. Epub 2017 Dec 21.
- Background: PubMed 36228453Mostafa SF, Abu Elyazed MM, Eid GM, Belal AM. Inter-semispinal plane (ISP) block for postoperative analgesia following cervical spine surgery: A prospective randomized controlled trial. J Clin Anesth. 2022 Dec;83:110974. doi: 10.1016/j.jclinane.2022.110974. Epub 2022 Oct 10.
- Background: PubMed 26149600Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
- Background: PubMed 21168100Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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.
Shereen E Abd Ellatif, MD principal investigator
Faculty of medicine, zagazig university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCP group and ISP group in people with Cervical Spine Surgery, run by Zagazig University at 1 site 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 5 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: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shereen E Abd Ellatif, MD (+20552336654 ext. 002, shosh.again@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Visual analogue scale (VAS)score (time frame: measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively). 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 NCT06083298, which also lists 5 linked publications.
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 17 Jul 2025.