NCT07238621

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Sep 2025Nov 2026

Study Start

First participant enrolled

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

November 15, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

postoperative painregional anesthesiaopioid free analgesiaibuprofenSerratus Posterior Superior Intercostal Plane Block

Outcome Measures

Primary Outcomes (1)

  • 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.

    Postoperative 24 hours

Secondary Outcomes (2)

  • Total tramadol consumption

    Postoperative 24 hours

  • Quality of Recovery scores

    Postoperative 24 hours

Study Arms (2)

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.

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.

Procedure: Serratus posterior superior intercostal plane block

Interventions

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

Group without peripheral nerve 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.

Serratus posterior superior intercostal plane block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • ONUR AVCI

    Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR
  • ZEYNEP M DEMİRCİ

    Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 20, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations