Anterior Cervical DiscectomyNCT06639022
Comparison of the Postoperative Analgesic Efficacy of SPSIPB and ESPB in Anterior Cervical Discectomy
A study testing Serratus posterior superior intercostal plane block, Erector spinae plane block and Group without peripheral nerve block in people with Anterior Cervical Discectomy and Peripheral Nerve Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Anterior cervical discectomy is an operation performed for complaints of pain, numbness or loss of strength due to cervical disc disease. With this operation, pressure due to herniation on the upper neck area, spinal cord or nerve roots is relieved. It is performed by microscopic method from the front of the neck. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anterior Cervical Discectomy, Peripheral Nerve Block, Pain Management
- What is being tested?
- Serratus posterior superior intercostal plane block, Erector spinae plane block and Group without peripheral nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 20 Nov 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years
- American Society of Anesthesiologists (ASA) score I-II-III
- Body Mass Index (BMI) between 18-30 kg/m2
Who cannot join
- Patients under 18 and over 80 years of age
- ASA score IV and above
- Patients with a history of bleeding diathesis
- BMI below 18 or above 30 kg/m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Altındağ, Ankara, 06000
Atakan Sezgi, M.D., 00905323327000, kansezgi@gmail.com
Musa Zengin, Associate Professor, 00905307716235, musazengin@gmail.com
About this study
Official title: Comparison of the Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block in Anterior Cervical Discectomy
Anterior cervical discectomy is an operation performed for complaints of pain, numbness or loss of strength due to cervical disc disease. With this operation, pressure due to herniation on the upper neck area, spinal cord or nerve roots is relieved. It is performed by microscopic method from the front of the neck.
Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.
In this study; it was aimed to compare the analgesic effectiveness of serratus posterior superior intercostal plane block and erector spinae plane block, with each other and with the control group in the postoperative period in patients who underwent anterior cervical discectomy.
- Being tested
- Serratus posterior superior intercostal plane block, Erector spinae plane block, Group without peripheral nerve block
- Keywords
- Anterior Cervical Discectomy, Serratus Posterior Superior Intercostal Plane Block, Erector Spinae Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus posterior superior intercostal plane blockProcedure or surgery
Serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of 0.25% bupivacaine under ultrasound guidance.
Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
Erector spinae plane blockProcedure or surgery
Erector spinae plane block will be performed on the patients using 30 ml of 0.25% bupivacaine under ultrasound guidance.
Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
Group without peripheral nerve blockProcedure or surgery
In the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Serratus posterior superior intercostal plane block | Active comparator | After the patients are monitored and in the supine position, after appropriate field sterilization, a serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. Receives: Procedure: Serratus posterior superior intercostal plane block |
| Erector spinae plane block | Active comparator | After the patients are monitored and in the supine position, after appropriate field sterilization, a erector spinae plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. Receives: Procedure: Erector spinae plane block |
| Group without peripheral nerve block | Active comparator | After the patients are monitored, they will be operated under general anesthesia without peripheral nerve block and intraoperative intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. Receives: Procedure: Group without peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
Measured: On the operation day
Secondary outcomes (2)
Intraoperative remifentanil consumption Intraoperative opioid consumption
Remifentanil consumption for intraoperative period will be recorded
Measured: Intraoperative period
Postoperative Tramadol Consumption
Tramadol consumption for 24 hours will be recorded
Measured: On the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2024
- Primary completion10 Oct 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cervical DiscectomyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Atakan Sezgi, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639022
- Sponsor's protocol ID
- AEŞH-EK1-2024-0126
- Status last verified
- Nov 2024
- First submitted
- 10 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block in Anterior Cervical Discectomy
- ClinicalTrials.gov ID
- NCT06639022
- Acronym / sponsor ID
- AEŞH-EK1-2024-0126
- Keywords
- Anterior Cervical Discectomy, Serratus Posterior Superior Intercostal Plane Block, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
Anterior cervical discectomy is an operation performed for complaints of pain, numbness or loss of strength due to cervical disc disease. With this operation, pressure due to herniation on the upper neck area, spinal cord or nerve roots is relieved. It is performed by microscopic method from the front of the neck.
Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.
In this study; it was aimed to compare the analgesic effectiveness of serratus posterior superior intercostal plane block and erector spinae plane block, with each other and with the control group in the postoperative period in patients who underwent anterior cervical discectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Serratus posterior superior intercostal plane block | Active comparator | Procedure: Serratus posterior superior intercostal plane blockAfter the patients are monitored and in the supine position, after appropriate field sterilization, a serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. |
| Erector spinae plane block | Active comparator | Procedure: Erector spinae plane blockAfter the patients are monitored and in the supine position, after appropriate field sterilization, a erector spinae plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. |
| Group without peripheral nerve block | Active comparator | Procedure: Group without peripheral nerve blockAfter the patients are monitored, they will be operated under general anesthesia without peripheral nerve block and intraoperative intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-80 years
- American Society of Anesthesiologists (ASA) score I-II-III
- Body Mass Index (BMI) between 18-30 kg/m2
Key exclusion criteria (4 listed)
- Patients under 18 and over 80 years of age
- ASA score IV and above
- Patients with a history of bleeding diathesis
- BMI below 18 or above 30 kg/m2
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 |
|---|---|---|
| Serratus posterior superior intercostal plane blockSerratus posterior superior intercostal plane block will be performed on the patients using 30 ml of 0.25% bupivacaine under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. | Procedure or surgery | Serratus posterior superior intercostal plane block |
| Erector spinae plane blockErector spinae plane block will be performed on the patients using 30 ml of 0.25% bupivacaine under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. | Procedure or surgery | Erector spinae plane block |
| Group without peripheral nerve blockIn the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. | Procedure or surgery | Group without peripheral nerve block |
Primary outcome
Pain Scores
Time frame: On the operation day
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
2 secondary outcomes
Intraoperative remifentanil consumption Intraoperative opioid consumption
Time frame: Intraoperative period
Postoperative Tramadol Consumption
Time frame: On the operation day
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 5 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus posterior superior intercostal plane block, Erector spinae plane block and Group without peripheral nerve block in people with Anterior Cervical Discectomy and Peripheral Nerve Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 3 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: looking for participants now, as of the sponsor's last update on 5 Nov 2024. 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 Turkey (Türkiye). 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. 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 Atakan Sezgi (00905323327000, kansezgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: On the operation day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2024.