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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Erector spina area block; Procedure: Retrolaminar block

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Didar Kyenshilik, Resident doctor; Phone Number: +902564441256; Email: didarkyenshilik@gmail.com
• Study Contact Backup: Name: Sinem Sarı Öztürk, Associate Professor; Phone Number: +902564441256; Email: sarisinem@yahoo.com

Study Locations

• Turkey
  • Aydın, Turkey, 09010
    • Recruiting
    • Adnan Menderes University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP BLOCK	Procedure: Erector spina area block; After anesthesia and surgical intervention, bilateral ESP passage will be performed with ultrasonography from the T10 level 3 cm lateral to the midline. After cleaning the area with povidone iodine before the block, T10 transverse output will be determined using a linear ultrasound probe. Local anesthetic will be applied to the erector spina with the use of the needle used for peripheral block procedures and transverse access. With the serum treatment from the local anesthesia application, the location of the needle will be correct with the hydrodissection method. After the location of the needle is confirmed, a mixture containing 20 ml of LA and serum will be applied and the same procedure will be repeated in the contralateral. 20 ml of total 40 ml LA is bupivacaine 0.5%, after 20 ml serum content.
Active Comparator: RLB BLOCK	Procedure: Retrolaminar block; The patient is in the prone position and the high-frequency linear ultrasound transducer is in parasagittal orientation, but the entry point is determined more medial than the ESP block. The needle entry point is 1-1.5 cm lateral to the targeted spinos process. The echogenic needle is advanced until it contacts the lamina in the craniocaudal plane and 0.5-1 for control. By giving cc 0.9 nacl solution, it is observed that the fluid is distributed between the erector spina muscle and the lamina. After the location of the needle is confirmed, a mixture of 20 ml of LA and saline will be applied and the same procedure will be repeated in the contralateral. 20 ml of total 40 ml LA will consist of bupivacaine 0.5% and 20 ml physiological saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qor-40 test (The recovery quality test)	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	24th hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS (Numerical rating scale)	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.	30 minutes,1st hour,6th hour,12th hour and 24th hour
Postoperative pain	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.	30 minutes,1st hour,6th hour,12th hour and 24th hour

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Erector spina plane block; postoperative pain; Retrolaminar block; Recovery Quality
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2022/06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No