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

NCT ID: NCT07065006

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2026-08-10

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

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.

Conditions

Postoperative Quality of Recovery and Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Qor-40 test (The recovery quality test)

Intervention Type: DIAGNOSTIC_TEST

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

Calculation of postoperative opioid consumption

Intervention Type: 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.

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.

Group Type: OTHER

Qor-40 test (The recovery quality test)

Intervention Type: DIAGNOSTIC_TEST

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

Calculation of postoperative opioid consumption

Intervention Type: 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.

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Calculation 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

SINEM SARI

prof.dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sinem Sarı

Role: CONTACT

sarisinem@yahoo.com

90 256 444 1 256

Other Identifiers

2025-150

Identifier Type: OTHER

Identifier Source: secondary_id

2025-150

Identifier Type: -

Identifier Source: org_study_id