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

A

Ataturk University

Status

Enrolling

Conditions

Lumbar Fixation Surgery

Treatments

Other: infiltration
Other: Erector Spinae Plane Block

Study type

Interventional

Funder types

Other

Identifiers

NCT06801574
B.30.2.YYU.0.01.00.00/90

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

84 participants in 3 patient groups

Group Erector Spinae Plane Block
Active Comparator group
Treatment:
Other: Erector Spinae Plane Block
Group Local Infiltration
Active Comparator group
Treatment:
Other: infiltration
Group Control
No Intervention group

Trial contacts and locations

1

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Central trial contact

Canan Atalay; Feyza Simsek

Data sourced from clinicaltrials.gov

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