Evaluation Of Three Different Anagesic Techniques In Patients Undergoing Lumbar Fixation Surgery

September 30, 2025 updated by: Feyza Şimşek, Ataturk University

EVALUATION OF POSTOPERATIVE EFFECT OF THREE DIFFERENT ANALGESIC TECHNIQUES IN PATIENTS UNDERGOING LUMBAR FIXATION SURGERY USING SALIVARY OPIORPHIN LEVEL: A PROSPECTIVE RANDOMIZED CLINICAL STUDY

Lumbar spinal stenosis is a degenerative condition characterized by the narrowing of the space surrounding the neurovascular structures of the lumbar vertebrae, resulting from age-related changes in the intervertebral discs, ligamentum flavum, and facet joints. It commonly causes unilateral pain in the lower back, hips, and legs, often described as cramping or burning. Postoperative pain management in these cases frequently involves oral opioids or intravenous administration using patient-controlled analgesia devices. However, opioids are associated with side effects such as reduced gastrointestinal motility, urinary retention, and respiratory depression.

To mitigate these issues, local anesthetic wound infiltration is widely employed by surgeons to manage postoperative pain and reduce opioid consumption following lumbar spinal surgeries.

The primary aim of this study is to compare the postoperative efficacy of three different analgesic methods in patients undergoing elective lumbar fixation surgery, using the percentage change in salivary opiorphin levels as a marker. Additionally, the study seeks to evaluate the correlation between these changes and postoperative pain scores, as well as the amount of opioids consumed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

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

  • Name: Canan Atalay
  • Phone Number: +90 (533) 363 53 18

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Erzurum, Turkey (Türkiye)
        • Recruiting
        • Ataturk University
        • Contact:
          • Canan Atalay

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 scheduled to undergo lumbar fixation surgery under general anesthesia
  • aged between 18 and 65 years,
  • American Society of Anesthesiologists physical status classification of I-II

Exclusion Criteria:

  • Patients with a known allergy to local anesthetics.
  • Patients who used opioid analgesics within 48 hours prior to sample collection.
  • Patients with a history of smoking or alcohol consumption.
  • Patients with conditions affecting salivary flow, such as xerostomia or those who have undergone radiotherapy.
  • Patients with infectious diseases known to be transmissible through saliva.
  • Patients with an ASA physical status classification of III or higher.
  • Patients unable to use a patient-controlled analgesia (PCA) device.
  • Patients who do not consent to the study procedures.

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
No Intervention: Group Control
Active Comparator: Group Erector Spinae Plane Block
Other: Erector Spinae Plane Block
After the surgical team places the final suture, while the patient is in the prone position, an ultrasound-guided ESP (Erector Spinae Plane) block will be administered bilaterally using a block needle. A total of 40 mL of 0.25% bupivacaine will be injected.
Active Comparator: Group Local Infiltration
Other: infiltration
Before the surgical team closes the incision, local infiltration with 40 mL of 0.25% bupivacaine will be performed at the surgical site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels
Time Frame: postoperative 24 hours
The primary aim of this study is to compare the postoperative efficacy of three different analgesic methods applied to patients undergoing elective lumbar fixation surgery by assessing the percentage change in salivary opiorphin levels. Additionally, the study aims to evaluate the correlation of these changes with postoperative Visual Analog Scale (VAS) pain scores and the amount of opioids consumed.
postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of opioid consumption
Time Frame: Postoperative 24 hours
the secondary objective was to measure the total amount of opioid consumption in the first 24 hours postoperatively
Postoperative 24 hours
Pain scores in first 24 hours at rest and at movement
Time Frame: postoperative 24 hours
Evaluation of pain scores during movement and rest within 24 hours postoperatively using the Visual Analog Scale
postoperative 24 hours
Correlation between basal Salivary Opiorphin Levels and total 24 hours opioid consumption and pain scores
Time Frame: postoperative 24 hours
The correlation between basal salivary opiorphin levels and total 24-hour opioid consumption, as well as pain scores will be analyzed to reveal any correlation
postoperative 24 hours

Collaborators and Investigators

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

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Feyza Simsek, Dr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 25, 2025

First Submitted That Met QC Criteria

January 25, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B.30.2.YYU.0.01.00.00/90

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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