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

November 4, 2024 updated by: Atakan Sezgi, Ankara Etlik City Hospital

Comparison of the Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block in Anterior Cervical Discectomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Ankara
      • Altındağ, Ankara, Turkey, 06000
        • Recruiting
        • Ankara Etlik City Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Serratus posterior superior intercostal plane block
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

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.
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, tramadol 100 mg) will be given.
Procedure: Group without peripheral nerve block
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.
Active Comparator: Erector spinae plane block
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: On the operation day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative remifentanil consumption Intraoperative opioid consumption
Time Frame: Intraoperative period
Remifentanil consumption for intraoperative period will be recorded
Intraoperative period
Postoperative Tramadol Consumption
Time Frame: On the operation day
Tramadol consumption for 24 hours will be recorded
On the operation day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

October 10, 2025

Study Completion (Estimated)

November 20, 2025

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AEŞH-EK1-2024-0126

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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