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

A

Aydin Adnan Menderes University

Status

Not yet enrolling

Conditions

Postoperative Quality of Recovery and Pain Management

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07065006
2025-150 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

88 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

88 participants in 2 patient groups

esp
Other group
Description:
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.
Treatment:
Other: Calculation of postoperative opioid consumption
Diagnostic Test: Qor-40 test (The recovery quality test)
wound LAI
Other group
Description:
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.
Treatment:
Other: Calculation of postoperative opioid consumption
Diagnostic Test: Qor-40 test (The recovery quality test)

Trial contacts and locations

0

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Central trial contact

Sinem Sarı

Data sourced from clinicaltrials.gov

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