Comparison of the Effects of Local Anesthetic Infiltration and Erector Spinae Plan (ESP) Block on Postoperative Recovery Quality and Pain in Lumbar Spinal Surgery

NCT07065006 | Completed DMC

• 1 other identifier: 2025-150
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the Effects of Local Anesthetic Infiltration and Erector Spinae Plan (ESP) Block on Postoperative Recovery Quality and Pain in Lumbar Spinal Surgery

Conditions

Postoperative Quality of Recovery and Pain Management

Keywords

wound local anesthetic infiltration; Erector Spinae Area (ESP) Block; quality of postoperative recovery; lumbar spinal surgeries

Outcome Measures

Primary Outcomes (1)

• Qor-40 test (The recovery quality test)

  scale of postoperative recovery quality at first 24th hour. Minimum score is 40=bad ,maximum score is 200=good

  24th hour

Secondary Outcomes (1)

• Postoperative opioid consumption

  30 minutes,1st hour,6th hour,12th hour and 24th hour

Study Arms (2)

esp

OTHER

After anesthesia and surgical intervention, bilateral ESP will be extended with ultrasound guidance from the midline 3 cm lateral at the T10 level. After the area is cleaned with povidone iodine before the block, the T10 transverse parts will be determined using a linear ultrasound probe. Local anesthetic will be applied to the erector spinae muscle with the needle used for peripheral block procedures and the transverse processor. Without administering local anesthesia, the location of the needle will be verified with the hydrodissection method with serum. After the location of the needle is verified, 20 ml of LA and a different mixture of serum will be changed and the same procedure will be repeated in the contralateral. 20 ml of the total 40 ml of LA will be bupivacaine 0.5%, which can be seen in 20 ml of serum.

Diagnostic Test: Qor-40 test (The recovery quality test); Other: Calculation of postoperative opioid consumption

wound LAI

OTHER

For patients assigned to wound infiltration, 40 mL (20 ml of the total 40 ml of LA will be bupivacaine 0.5%, which can be seen in 20 ml of serum) will be infiltrated on both sides of the wound edges after closure.

Diagnostic Test: Qor-40 test (The recovery quality test); Other: Calculation of postoperative opioid consumption

Interventions

Qor-40 test (The recovery quality test) DIAGNOSTIC_TEST

Scale of postoperative recovery quality at first 24th hour. Minimum score is 40=bad ,maximum score is 200=good

esp; wound LAI

Calculation of postoperative opioid consumption OTHER

Postoperative opioid consumptions on the pca (patient controlled analgesia) device of the patients will be recorded in Postoperative 30.min,1.,6.,12.,24. Opioid consumptions on the pca device of the patients will be recorded in 30.min,1.,6.,12.,24. hours.

esp; wound LAI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective lumbar surgery performed ASA I-III 18-75 years old

You may not qualify if:

• Refusal at enrollment
• Request for withdrawal from the study
• Inability to give informed consent
• Emergency surgery
• Bleeding diathesis
• Presence of contraindications to the LA agents used in this study
• Use of chronic opioids
• Psychiatric disorders
• Presence of infection at the injection site

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes Üniversitesi Tıp Fakulresi Hastanesi

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Bites and Stings

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr.

Model Details: The study was designed as a double-blind, prospective randomized controlled trial.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 15, 2025
• Study Start: July 10, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

TU (1)