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Clinical Trials/NCT07065006
NCT07065006
Not yet recruiting
Not Applicable

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

Aydin Adnan Menderes University0 sites88 target enrollmentStarted: July 10, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Aydin Adnan Menderes University
Enrollment
88
Primary Endpoint
Qor-40 test (The recovery quality test)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Qor-40 test (The recovery quality test)

Time Frame: 24th hour

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

Secondary Outcomes

  • Postoperative opioid consumption(30 minutes,1st hour,6th hour,12th hour and 24th hour)

Investigators

Sponsor
Aydin Adnan Menderes University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

SINEM SARI

prof.dr.

Aydin Adnan Menderes University

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