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CTRI Number  CTRI/2021/11/038059 [Registered on: 15/11/2021] Trial Registered Prospectively
Last Modified On: 27/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Usefulness of erector spinae blocks for spine surgeries  
Scientific Title of Study   Efficacy of bilateral erector spinae block for intraoperative and postoperative analgesia in lumbar decompression surgeries  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka G 
Designation  Assistant professor  
Affiliation  Rajrajeshwari medical college and hospital  
Address  #202,Rajrajeshwari medical college and hospital,Mysore road, kambipura,Bangalore
Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore
Bangalore
KARNATAKA
560074
India 
Phone  7795439546  
Fax    
Email  drpriyanka2405@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priyanka G 
Designation  Assistant professor  
Affiliation  Rajrajeshwari medical college and hospital  
Address  Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore
Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore
Bangalore
KARNATAKA
560074
India 
Phone  7795439546  
Fax    
Email  drpriyanka2405@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priyanka G 
Designation  Assistant professor  
Affiliation  Rajrajeshwari medical college and hospital  
Address  Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore
Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore
Bangalore
KARNATAKA
560074
India 
Phone  7795439546  
Fax    
Email  drpriyanka2405@gmail.com  
 
Source of Monetary or Material Support  
Rajrajeshwari medical college and hospital  
 
Primary Sponsor  
Name  Rajrajeshwari medical college and hospital  
Address  Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priyanka G  Rajrajeshwari medical college and hospital   #202,Mysore road,kengri satellite town, kambipura
Bangalore
KARNATAKA 
7795439546

drpriyanka2405@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajrajeshwari medical college and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector spinae block   Erector spinae block is block given using local anesthesia between Erector spinae muscle and transverse process of the spine in order to block dorsal and ventral rami nerves  
Comparator Agent  Paracetamol iv 1g  Paracetamol iv 1g is given just before the incision  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 patients  
 
ExclusionCriteria 
Details  Coagulation disorders
BMI <18 or >30
Patient with surgical site infections
Patients with unstable spine integrity like fracture or scoliosis
Hypertensive, cardiac and diabetic patients  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of erector spinae block as an analgesia in lumbar decompression surgeries   To study the duration of action of erector spinae block as analgesia in lumbar decompression surgeries  
 
Secondary Outcome  
Outcome  TimePoints 
To study how much effectively erector spinae block reduces opiods, inhalation anesthetics and muscle requirements intraoperatively  3 hrs 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2021 
Date of Study Completion (India) 08/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Efficacy of ultrasound guided erector spinae plane block as analgesia both during intraoperative and postoperative in patient undergoing lumbar spinal decompression surgeries:A randomization controlled study  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Erector spinae plane (ESP) block is a regional anesthesia technique in which local anesthesia is injected deep to Erector spinae muscle and transverse process under ultrasound guidance.  This block has been shown to provide good postoperative analgesics for thoracic, breast and spine surgeries .primarily, the anatomic location of the ESP  block is thoracic level(89.9%), followed by lumbar (9.3%) and cervical (0.8%).ESP  block is a paraspinal interfascial plane block targeting the ventral  and dorsal branches rami of the spinal nerves.      
                                              
We conducted a study to determine whether erector spinae block is effective in providing intraoperative and postoperative analgesia in lumbar decompression surgeries.

·       50 patients who were randomly allocated into two group, group ESB (erector spinae block )and group MMA (multimodal analegsia). 

·       The study was done to know whether erector spinae block could reduce perioperative pain, the requirement of opioid and muscle relaxant consumption during the surgery and postoperative analgesia. 

·       Data analysis was done using SPSS software version 16. Anthropometric measurements and vitals were shown using mean and standard deviation. Independent t-test used to find the difference in between mean P value < 0.05 is taken as significant. 

·       Our study showed that there were significant changes in the hemodynamic parameters i.e. SBP, DBP, MAP and HR (P<0.0001) intraoperatively during the incision and first 10 min interval in MMA group compared to ESB group. 

·       There was increase in opioid and muscle relaxant consumption after incision, after first 10 mins after the incision but there was no significant difference in total consumption.

·        The rescue analgesia requirement was highly significant at 4th, 8th, 12th hour after the procedure in control group compared to ESP group (figure 7). Patients in ESP group had rescue analgesia at around 15 -18 hour after the procedure. The analgesic duration of ESP block was approximately 18-20 hours.

·       The limitation of our study we didn’t take in to account regarding inhalation agents consumption, hence we don’t know how it ESB can infer the depth of anaesthesia and whether ESB block has any effect on the blood loss during the surgery.  Patients with multiple level disectomy surgery were not  included in our study somehow  further studies can be done either by inserting a catheter in erector spine plane to increase the efficacy of the block. The evaluation of chronic pain after surgery was not done in our study.

·       So we conclude that bilateral US-ESPB single shot block seems to be a useful intervention for providing adequate pain management during both intraoperative and postoperative period for patients undergoing lumbar spine single or double level discectomy.

 

 

 
 
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