- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238621
Postoperative Analgesic Efficacy of SPSIPB in Anterior Cervical Discectomy
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sivas
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Sivas, Sivas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group without peripheral nerve block
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.
|
In the postoperative period a ibuprofen dose of 400 mg every 8 hours were administered iv for multimodal analgesia
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Active Comparator: Serratus posterior superior intercostal plane block
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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Recovery scores
Time Frame: Postoperative 24 hours
|
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.
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Postoperative 24 hours
|
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Total tramadol consumption
Time Frame: Postoperative 24 hours
|
Postoperative total analgesic need was recorded as "milligram" in unit.
|
Postoperative 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ONUR AVCI, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
- Study Chair: ZEYNEP M DEMİRCİ, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-07/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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