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CTRI Number  CTRI/2023/10/059119 [Registered on: 26/10/2023] Trial Registered Prospectively
Last Modified On: 25/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of pain relief between erector spinae block and local wound site infiltration in patients undergoing lumbar spinal surgeries 
Scientific Title of Study   The comparison of the efficacy between bilateral ultrasound guided erector spinae block versus incision site infiltration for duration of analgesia in lumbar spinal surgery using levobupivacaine: A prospective, randomized comparative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karthik G S 
Designation  Professor  
Affiliation  Rajarajeswari medical college and hospital  
Address  Department of Anaesthesiology Rajarajeshwari medical college and hospital . Kambipura, Mysore road, Bangalore Bangalore KARNATAKA 560074 India

Bangalore
KARNATAKA
560074
India 
Phone  9538220515  
Fax    
Email  drgskarthik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Karthik G S 
Designation  Professor  
Affiliation  Rajarajeswari medical college and hospital  
Address  Department of Anaesthesiology Rajarajeshwari medical college and hospital . Kambipura, Mysore road, Bangalore Bangalore KARNATAKA 560074 India

Bangalore
KARNATAKA
560074
India 
Phone  9538220515  
Fax    
Email  drgskarthik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prajyot Bhurli 
Designation  Post graduate  
Affiliation  Rajarajeswari medical college and hospital  
Address  Department of Anaesthesiology Rajarajeshwari medical college and hospital . Kambipura, Mysore road, Bangalore Bangalore KARNATAKA 560074 India

Bangalore
KARNATAKA
560074
India 
Phone  7022030837  
Fax    
Email  prajyot.bhurli2013@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari medical college and hospital Kambipura, Mysore road, Bangalore, Karnataka 
 
Primary Sponsor  
Name  Rajarajeswari medical college and hospital  
Address  Kambipura, Mysore road, Bangalore, Karnataka, 560074 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Karthik G S   Rajarajeswari medical college and hospital   Department of Anesthesiology , Rajarajeswari medical college and hospital , kambipura , mysore road , Bangalore karnataka
Bangalore
KARNATAKA 
9538220515

drgskarthik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, RAJARAJESHWARI 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: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector spinae block  ESPB will be performed in group A before extubation. At the end of surgery, under strict aseptic conditions, counting above from L4 vertebrae from the tuffiers line , L3 vertebrae will be identified. A curvilinear USG probe will be placed across the L2 spine and probe will be moved to identify L2 lateral process. 20 ml of 0.25% Inj levobupivacaine is injected below the fascia of erector spinae level using 23G Quincke needle by out of plane technique. Before this 2-3 ml of NS will be injected to make out the spread. 
Intervention  Inj Levobupivacaine 0.25% in Erector spinae block and local wound site infiltration   Inj Levobupivacaine 0.25% 20 ml will be injected in two separate groups to compare their efficacy postoperatively in the first 24 hours till the need of first analgesia. 1.Inj Levobupivacaine 0.25% 20 ml in erector spinae muscle 2. Inj Levobupivacaine 0.25% 20 ml as a wound infiltration at the local surgical site.  
Comparator Agent  Local wound site infiltration   Wound site infiltration will be performed in group B before extubation. At the surgery , at the wound site , local infiltration with 20 ml of 0.25% levobupivacaine is injected.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2 patients. Patients aged 20-65 yrs undergoing single level lumbar discectomy surgeries.
 
 
ExclusionCriteria 
Details  Patient refusal
Patients with known hypersensitivity to local anaesthetics
Patient with bleeding disorder, uncontrolled Diabetes Mellitus, severe Renal & Liver Diseases
Patient with Epilepsy
Mentally unstable patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare & assess the analgesic efficacy postoperatively between Erector spinae block & local wound site infiltration.   To compare & assess the analgesic efficacy postoperatively between Erector spinae block & local wound site infiltration in FIRST 24 hrs.  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the need of rescue analgesia postoperatively between Erector spinae block & local wound site infiltration
Comparison of hemodynamic parameters. complications if any 
Post operative period for first 24 hrs 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   06/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Spine surgeries are a widely accepted treatment for patients with pathology in the spine. However, postoperative pain following these surgeries is one of the most common complications.In addition, spinal surgery is one of the most painful surgical procedures, creating a major challenge in pain management. This pain begins with an irritation or inflammatory reaction by surgical trauma of the afferent neuron in different back tissues such as ligaments, nerve root sleeves, intervertebral discs, dura, muscles, facet joint capsules and fascia. 
Erector spinae plane (ESP) block is an interfascial blockade, first described by Forero in 2016. The erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra and LA is distributed in the cranio-caudal fascial plane one dermatome a median of each 3.4 ml of injected volume. 

Aim is to Compare The Efficacy Of Ultrasound Guided Erector spinae block Vs wound infiltration For Post Operative Analgesia In Lumbar spine surgery using levobupivacaine. 

Method of collection of data. 

After obtaining institutional ethical committee clearance, a comparative study will be carried in Rajarajeshwari Medical college and Hospital in Department of Anaesthesia.
The purpose, the procedure and the risks involved with the study will be explained to the patient and an informed consent will be taken. 

50 patients of ASA 1 and ASA 2 aged between 20 and 65 years scheduled for elective single level lumbar discectomy surgeries will be selected. All patients will be subjected to detailed preanesthetic evaluation. Routine and specific investigations will be done as per patients clinical evaluation along with optimising with regular medication if required. Patients will be randomly allocated into two groups of 25 each by single blinded open envelope technique. 

Group A – Patients will receive 25 ml of 0.25% Levobupivacaine at the level of L2.
Group B – Patients will receive 25 ml of 0.25% Levobupivacaine over the the surgical wound site.

All the patients will be reviewed and explained about the procedure.
Patients will be kept nil by oral for 6 hours and will be given T.Pantoprazole 40mg T. Alpralozolam.
On arrival of the patient to the operation theatre, monitors will be connected and base line respiratory rate, pulse rate, non-invasive blood pressure, SPO2 and ECG recorded. Intravenous line of 18G shall be secured and intravenous fluids will be started as per requirement.
Patient in supine position with adequate preoxygenation and premedication with Inj Midazolam 0.01mg/kg and Inj Glycopyrolate 0.2mg will be induced with Inj Fentanyl 1-2mcg/kg, Inj Propofol 2mg/kg and Inj. Vecuronium 0.1mg/kg.
After obtaining adequate muscle relaxation, laryngoscopy will be done and intubated with endotracheal tube. Bilateral airway entry is confirmed and secured appropriately.
Patient is changed to prone position and hemodynamic parameters will be monitored throughout the procedure at regular intervals.

At the end of surgery, under strict aseptic conditions, counting above from L4 vertebrae from the tuffiers line , L3 vertebrae will be identified. A curvilinear USG probe will be placed across the L2 spine and probe will be moved to identify L2 lateral process.
20 ml of 0.25% levobupivacaine is injected below the fascia of erector spinae level using 23G Quincke needle by out of plane technique. Before this 2-3 ml of NS will be injected to make out the spread. In the other group, local wound site infiltration is done using 20 ml of 0.25% levobupivacaine. 

The patient is changed to supine position and extubation will be done after a reversal of residual neuromuscular block with neostigmine (0.05 mg/kg) and glycopyrrolate (0.01 mg/kg) at the end of the surgery. Patients will be transferred to post anesthesia care unit to monitor hemodynamic parameters, postoperative pain, sedation, nausea and vomiting at 0,1,2,4,6,8,12,16,20,24hrs. Patients will be evaluated pain postoperatively for the duration of analgesia and pain will be assessed using a standard 10 cm linear VAS.
Pain assessment will be done 20 minutes after extubation which will be considered as zero time.
Total duration of analgesia will be taken from zero time till the first rescue analgesic requirement.
When VAS score is more than or equal to 4, Inj.Paracetamol 1g will be given as rescue analgesia. Total number of doses of Inj Paracetamol 1g given in 24 hours will be noted.
Patients will be left out of the study in case of block failures

 
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