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

NCT ID: NCT05792124

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-02-01

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESP BLOCK

Group Type: EXPERIMENTAL

Erector spina area block

Intervention Type: PROCEDURE

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.

RLB BLOCK

Group Type: ACTIVE_COMPARATOR

Retrolaminar block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Adnan Menderes University Faculty of Medicine

Aydin, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Didar Kyenshilik, Resident doctor

Role: CONTACT

didarkyenshilik@gmail.com

+902564441256

Sinem Sarı Öztürk, Associate Professor

Role: CONTACT

sarisinem@yahoo.com

+902564441256

Other Identifiers

2022/06

Identifier Type: -

Identifier Source: org_study_id