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
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