Anterior Cervical DiscectomyNCT07238621
Postoperative Analgesic Efficacy of SPSIPB in Anterior Cervical Discectomy
A study testing The group treated with intravenous analgesics and Serratus posterior superior intercostal plane block in people with Anterior Cervical Discectomy and Serratus Posterior Superior Intercostal Plane Block, run by Cumhuriyet University 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, Serratus Posterior Superior Intercostal Plane Block, Postoperative Pain Management
- What is being tested?
- The group treated with intravenous analgesics and Serratus posterior superior intercostal plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2025to 30 Nov 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 18 years of age who underwent percutaneous nephrolithotomy under general anesthesia and were I-II-III according to the American Society of Anesthesiologists (ASA) risk classification were included in the study.
Who cannot join
- patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with known allergies to any of the study drugs,
- patients with unstable hemodynamics,
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- patients who could not cooperate during postoperative pain assessment
- patients who wanted to withdraw from the study,
- patients with alcohol and drug addiction,
- patients with musculoskeletal abnormalitie
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Sivas, 58140
About this study
Official title: Effects of the Serratus Posterior Superior Intercostal Plane Block on Postoperative Pain Levels and Analgesic Requirement in Patients Undergoing Cervical Disc Herniation Surgery
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, and with the control group in the postoperative period in patients who underwent anterior cervical discectomy.
- Conditions
- Anterior Cervical Discectomy, Serratus Posterior Superior Intercostal Plane Block, Postoperative Pain Management, Postoperative Pain, Cervical Disc Herniation
- Being tested
- The group treated with intravenous analgesics, Serratus posterior superior intercostal plane block
- Keywords
- postoperative pain, regional anesthesia, opioid free analgesia, ibuprofen, Serratus Posterior Superior Intercostal Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group treated with intravenous analgesicsProcedure or surgery
In the postoperative period a ibuprofen dose of 400 mg every 8 hours were administered iv for multimodal analgesia
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.
| Study group | Role | What they receive |
|---|---|---|
| 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, paracetamol) will be given. Receives: Procedure: The group treated with intravenous analgesics |
| Serratus posterior superior intercostal plane block | Active comparator | In this study, the intervention will be the SPSIPB. The block will be performed with the patient in the lateral decubitus position.A high-frequency (7-12 MHz) linear transducer will be placed in the transverse plane at the level of the spina scapulae, and the superior medial border of the scapula, the trapezius muscle, the rhomboid muscle, the serratus posterior superior muscle (SPSM), and the second and third ribs will be visualized.
Subsequently, a sonovisible needle will be advanced just medial to the scapula, targeting the area between the second and third ribs to reach the fascial plane between the SPSM and the intercostal muscles. After the needle makes gentle contact with the rib, 1-2 mL of saline will be used to confirm the correct plane. A total of 30 mL of 0.25% bupivacaine will then be administered into this fascial plane between the SPSM and the intercostal muscle.In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, paracetamol 1000 mg) will be given. Receives: Procedure: Serratus posterior superior intercostal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Scores
Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Measured: Postoperative 24 hours
Secondary outcomes (2)
Total tramadol consumption
Postoperative total analgesic need was recorded as "milligram" in unit.
Measured: Postoperative 24 hours
Quality of Recovery scores
Quality of recovery-15 (QoR15) scale was used for the assessment of patients satisfaction. The scores of QoR15 changes between 0 to 150 points. 0 point means "there is no satisfaction." Higher scores mean indicating a good quality of recovery and better outcome.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start30 Sep 2025
- Primary completion10 Oct 2026 (estimated)
- Study completion30 Nov 2026 (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.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
- Investigators
- ONUR AVCI, Principal investigator, Sivas Cumhuriyet University School of Medicine, Anesthesiology and ReanimationZEYNEP M DEMİRCİ, Study chair, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238621
- Sponsor's protocol ID
- 2025-07/24
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Serratus Posterior Superior Intercostal Plane Block on Postoperative Pain Levels and Analgesic Requirement in Patients Undergoing Cervical Disc Herniation Surgery
- ClinicalTrials.gov ID
- NCT07238621
- Acronym / sponsor ID
- 2025-07/24
- Conditions
- Anterior Cervical Discectomy, Serratus Posterior Superior Intercostal Plane Block, Postoperative Pain Management, Postoperative Pain, Cervical Disc Herniation
- Keywords
- postoperative pain, regional anesthesia, opioid free analgesia, ibuprofen, Serratus Posterior Superior Intercostal Plane Block
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 Nov 2025 (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, and with the control group in the postoperative period in patients who underwent anterior cervical discectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group without peripheral nerve block | Active comparator | Procedure: The group treated with intravenous analgesicsAfter the patients are monitored, they will be operated under general anesthesia without peripheral nerve block and intraoperative intravenous analgesics (dexketoprofen 50 mg, paracetamol) will be given. |
| Serratus posterior superior intercostal plane block | Active comparator | Procedure: Serratus posterior superior intercostal plane blockIn this study, the intervention will be the SPSIPB. The block will be performed with the patient in the lateral decubitus position.A high-frequency (7-12 MHz) linear transducer will be placed in the transverse plane at the level of the spina scapulae, and the superior medial border of the scapula, the trapezius muscle, the rhomboid muscle, the serratus posterior superior muscle (SPSM), and the second and third ribs will be visualized. Subsequently, a sonovisible needle will be advanced just medial to the scapula, targeting the area between the second and third ribs to reach the fascial plane between the SPSM and the intercostal muscles. After the needle makes gentle contact with the rib, 1-2 mL of saline will be used to confirm the correct plane. A total of 30 mL of 0.25% bupivacaine will then be administered into this fascial plane between the SPSM and the intercostal muscle.In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, paracetamol 1000 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 (1 listed)
- Adult patients over 18 years of age who underwent percutaneous nephrolithotomy under general anesthesia and were I-II-III according to the American Society of Anesthesiologists (ASA) risk classification were included in the study.
Key exclusion criteria (10 listed)
- patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with known allergies to any of the study drugs,
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 |
|---|---|---|
| The group treated with intravenous analgesicsIn the postoperative period a ibuprofen dose of 400 mg every 8 hours were administered iv for multimodal analgesia | Procedure or surgery | Group without peripheral nerve block |
| 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 |
Primary outcome
Numeric Rating Scale (NRS) Scores
Time frame: Postoperative 24 hours
Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
2 secondary outcomes
Total tramadol consumption
Time frame: Postoperative 24 hours
Quality of Recovery scores
Time frame: Postoperative 24 hours
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 25 Feb 2026.
- Individual participant dataSharing planned: No
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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.
ONUR AVCI principal investigator
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
ZEYNEP M DEMİRCİ study chair
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The group treated with intravenous analgesics and Serratus posterior superior intercostal plane block in people with Anterior Cervical Discectomy and Serratus Posterior Superior Intercostal Plane Block, run by Cumhuriyet University 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 1 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. 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?
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?
Numeric Rating Scale (NRS) Scores (time frame: Postoperative 24 hours). 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 25 Feb 2026.