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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Lumbar Fixation Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group Erector Spinae Plane Block

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type 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 Local Infiltration

Group Type ACTIVE_COMPARATOR

infiltration

Intervention Type 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 Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No