Evaluation of the Postoperative Analgesic Efficacy of SPSIPB in Anterior Cervical Discectomy

NCT ID: NCT07238621

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Cervical Discectomy Serratus Posterior Superior Intercostal Plane Block Postoperative Pain Management Postoperative Pain Cervical Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Group without peripheral nerve block

Intervention Type PROCEDURE

In the postoperative period a ibuprofen dose of 400 mg every 8 hours were administered iv for multimodal analgesia

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.

Group Type ACTIVE_COMPARATOR

Serratus posterior superior intercostal plane block

Intervention Type PROCEDURE

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.

Interventions

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Group without peripheral nerve block

In the postoperative period a ibuprofen dose of 400 mg every 8 hours were administered iv for multimodal analgesia

Intervention Type PROCEDURE

Serratus posterior superior intercostal plane block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumhuriyet University

OTHER

Sponsor Role lead

Responsible Party

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Oguz Gundogdu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ONUR AVCI

Role: PRINCIPAL_INVESTIGATOR

Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

ZEYNEP M DEMİRCİ

Role: STUDY_CHAIR

Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

Locations

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Sivas Cumhuriyet University

Sivas, Sivas, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2025-07/24

Identifier Type: -

Identifier Source: org_study_id

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