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CompletedNCT07065006Updated May 6, 2026

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

An interventional study of Qor-40 test (The recovery quality test) and Calculation of postoperative opioid consumption in Postoperative Quality of Recovery and Pain Management, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the detailed description

The study was designed as a double-blind, prospective randomized controlled study. Blindness; healthcare professionals who will monitor the patient's pain in the postoperative period will not know whether ESP or wound local anesthetic infiltration block was applied. Randomization of the patients was planned to be done using computer support. It was planned to include 44 participants in the ESP block and wound local anesthetic infiltration groups. The current pain status of the patients in the ESP block and wound local anesthetic infiltration groups in the postoperative period will be evaluated with NRS (Numerical rating scale) at certain time intervals (30th min, 1st, 6th, 12th, 24th hour) during rest and movement. When the patients' NRS scores are 4 and above, intravenous analgesic will be administered additionally and the number of bolus doses of the patients with PCA in the first 24 hours will be recorded. The recovery quality of the patients who underwent both ESP block and RLB block at the postoperative 24th hour will be evaluated with the scoring system (QoR-40). Additionally, the patients' hemodynamic values will be recorded during these intervals.

02

Conditions studied

  • Postoperative Quality of Recovery and Pain Management

Keywords

  • wound local anesthetic infiltration
  • Erector Spinae Area (ESP) Block
  • quality of postoperative recovery
  • lumbar spinal surgeries
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 80 is close to the median of 78 across 1,024 interventional studies indexed under Agnosia.

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Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Refusal at enrollment
  2. Request for withdrawal from the study
  3. Inability to give informed consent
  4. Emergency surgery
  5. Bleeding diathesis
  6. Presence of contraindications to the LA agents used in this study
  7. Use of chronic opioids
  8. Psychiatric disorders
  9. Presence of infection at the injection site
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
80 participants (actual)

Study arms

  • Other
    esp

    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

  • Other
    wound LAI

    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

  • Diagnostic testQor-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

  • OtherCalculation of postoperative opioid consumption

    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.

06

What researchers measure

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

    Time frame: 24th hour

Secondary outcomes

  1. Postoperative opioid consumption

    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.

    Time frame: 30 minutes,1st hour,6th hour,12th hour and 24th hour

07

Study locations

1 site
  • Adnan Menderes Üniversitesi Tıp Fakulresi Hastanesi
    Aydin, 09100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07065006
Lead sponsor
Aydin Adnan Menderes University
Responsible party
SINEM SARI (prof.dr., Aydin Adnan Menderes University) — Principal investigator
First posted
Jul 15, 2025
Start date
Jul 10, 2025
Primary completion
Dec 12, 2025
Completion
Dec 12, 2025
Last update
May 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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