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

NCT06801574 | Recruiting

• 1 other identifier: B.30.2.YYU.0.01.00.00/90
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Fixation Surgery

Keywords

lumbar fixation surgery; erector spinal plane block; local infiltration

Outcome Measures

Primary Outcomes (1)

• Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels

  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 Outcomes (3)

• Total amount of opioid consumption

  Postoperative 24 hours

• Pain scores in first 24 hours at rest and at movement

  postoperative 24 hours

• Correlation between basal Salivary Opiorphin Levels and total 24 hours opioid consumption and pain scores

  postoperative 24 hours

Study Arms (3)

Group Erector Spinae Plane Block

ACTIVE COMPARATOR

Other: Erector Spinae Plane Block

Group Local Infiltration

ACTIVE COMPARATOR

Other: infiltration

Group Control

NO INTERVENTION

Interventions

Erector Spinae Plane Block OTHER

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.

Group Erector Spinae Plane Block

infiltration OTHER

Before the surgical team closes the incision, local infiltration with 40 mL of 0.25% bupivacaine will be performed at the surgical site.

Group Local Infiltration

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Deng K, Huang K, Wu GF. Ultrasound-guided erector spinae plane block in posterior lumbar surgery (Review). Biomed Rep. 2024 Apr 22;20(6):95. doi: 10.3892/br.2024.1783. eCollection 2024 Jun.

  PMID: 38765858 RESULT

• Hong B, Baek S, Kang H, Oh C, Jo Y, Lee S, Park S. Regional analgesia techniques for lumbar spine surgery: a frequentist network meta-analysis. Int J Surg. 2023 Jun 1;109(6):1728-1741. doi: 10.1097/JS9.0000000000000270.

  PMID: 36912781 RESULT

• Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.

  PMID: 26727925 RESULT

Study Officials

• Feyza Simsek

  Dr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feyza Simsek

CONTACT

+90 554 947 52 61; feyzasimsek0205@gmail.com

Canan Atalay

CONTACT

+90 (533) 363 53 18

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: January 30, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)