Comparison of the Postoperative Analgesic Efficacy of SPSIPB and ESPB in Anterior Cervical Discectomy

NCT06639022 | Recruiting

• 1 other identifier: AEŞH-EK1-2024-0126
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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, with each other and with the control group in the postoperative period in patients who underwent anterior cervical discectomy.

Conditions

Anterior Cervical Discectomy; Peripheral Nerve Block; Pain Management

Keywords

Anterior Cervical Discectomy; Serratus Posterior Superior Intercostal Plane Block; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.

  On the operation day

Secondary Outcomes (2)

• Intraoperative remifentanil consumption Intraoperative opioid consumption

  Intraoperative period

• Postoperative Tramadol Consumption

  On the operation day

Study Arms (3)

Serratus posterior superior intercostal plane block

ACTIVE COMPARATOR

After the patients are monitored and in the supine position, after appropriate field sterilization, a serratus posterior superior intercostal plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given.

Procedure: Serratus posterior superior intercostal plane block

Erector spinae plane block

ACTIVE COMPARATOR

After the patients are monitored and in the supine position, after appropriate field sterilization, a erector spinae plane block will be performed on the patients using 30 ml of local anesthetic solution (0.25% bupivacain) under ultrasound guidance. In the intraoperative period, intravenous analgesics (dexketoprofen 50 mg, tramadol 100 mg) will be given.

Procedure: Erector spinae plane block

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, tramadol 100 mg) will be given.

Procedure: Group without peripheral nerve block

Interventions

Serratus posterior superior intercostal plane block 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.

Serratus posterior superior intercostal plane block

Erector spinae plane block PROCEDURE

Erector spinae 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.

Erector spinae plane block

Group without peripheral nerve block PROCEDURE

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.

Group without peripheral nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years
• American Society of Anesthesiologists (ASA) score I-II-III
• Body Mass Index (BMI) between 18-30 kg/m2

You may not qualify if:

• Patients under 18 and over 80 years of age
• ASA score IV and above
• Patients with a history of bleeding diathesis
• BMI below 18 or above 30 kg/m2

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Altındağ, Ankara, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Atakan Sezgi

CONTACT

00905323327000; kansezgi@gmail.com

Musa Zengin

CONTACT

00905307716235; musazengin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: October 10, 2025
• Study Completion: November 20, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

TU (1)