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
Primary Purpose
Postoperative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector spina area block
Retrolaminar block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Recovery Quality, postoperative pain, Erector spina plane block, Retrolaminar block
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
Sites / Locations
- Adnan Menderes University Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ESP BLOCK
RLB BLOCK
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05792124
First Posted
January 19, 2023
Last Updated
March 29, 2023
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT05792124
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Recovery Quality, postoperative pain, Erector spina plane block, Retrolaminar block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESP BLOCK
Arm Type
Experimental
Arm Title
RLB BLOCK
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Erector spina area block
Intervention Description
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
Intervention Name(s)
Retrolaminar block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Qor-40 test (The recovery quality test)
Description
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
Time Frame
24th hour
Secondary Outcome Measure Information:
Title
NRS (Numerical rating scale)
Description
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.
Time Frame
30 minutes,1st hour,6th hour,12th hour and 24th hour
Title
Postoperative pain
Description
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.
Time Frame
30 minutes,1st hour,6th hour,12th hour and 24th hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Didar Kyenshilik, Resident doctor
Phone
+902564441256
Email
didarkyenshilik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sinem Sarı Öztürk, Associate Professor
Phone
+902564441256
Email
sarisinem@yahoo.com
Facility Information:
Facility Name
Adnan Menderes University Faculty of Medicine
City
Aydın
ZIP/Postal Code
09010
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
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
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