Comparison of the Effects of Retro Laminar Block (RLB) and Erector Spina Area Block (ESP) on Postoperative Recovery Quality and Pain in Lumbar Spinal Surgery

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Procedure: Erector spina area block; Procedure: Retrolaminar block

• Registration Number: NCT05792124
• Lead Sponsor: Aydin Adnan Menderes University

Brief Summary

The aim of this study is to compare the efficacy of erector spinae plane block (ESPB) and Retrolaminar Block on postoperative recovary quality and pain after lumbar spinal surgery

Detailed Description

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

Blindness; The healthcare professionals who will monitor the patient's pain in the post-operative period will not know which of the ESP or RLB block is applied. Randomization of the patients was planned using computer aided. It was envisaged to include 40 participants each in the ESP block and RLB block groups. The current pain status of the patients in the ESP block and RLB block groups in the postoperative period was determined by NRS (Numerical rating scale) at rest and motion at certain hour intervals (30 .min,1.,6.,12.,24. hours) will be done, when the patients' NRS scores are 4 and above, an additional intravenous analgesic will be administered and the number of bolus doses 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 a (QoR-40) scoring system. In addition, the hemodynamic values of the patients will be recorded in these intervals.

Study Timeline

• Study First Submitted: 2023-01-19
• Study Start: 2023-01-31
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients undergoing lumbar spinal surgery under elective conditions
• ASA I-III
• Between 18-75 ages

Exclusion Criteria

• refuse during registration
• request to be dismissed from study
• failure to give informed consent
• emergency surgery
• bleeding diathesis
• Presence of contraindications to the LA agents used in this study chronic use of opioids psychiatric disorders the presence of infection at the injection site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ESP BLOCK	Erector spina area block	-
RLB BLOCK	Retrolaminar block	-

Primary Outcome Measures

Name	Time	Method
Qor-40 test (The recovery quality test)	24th hour	For this purpose, patients will be subjected to the Short Form-40- test, which is a short scale of postoperative recovery quality at first 24th hour.Minimum score is 40=bad ,maximum score is 200=good

Secondary Outcome Measures

Name	Time	Method
NRS (Numerical rating scale)	30 minutes,1st hour,6th hour,12th hour and 24th hour	It is a pain intensity determination system based on the system where the person tells a point between 0 =(no pain), 10= (unbearable pain) and to describe their pain.
Postoperative pain	30 minutes,1st hour,6th hour,12th hour and 24th hour	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.

Trial Locations

Locations (1)

Adnan Menderes University Faculty of Medicine; 🇹🇷 Aydın, Turkey