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CTRI Number  CTRI/2019/05/018870 [Registered on: 01/05/2019] Trial Registered Prospectively
Last Modified On: 14/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Clinical usefulness of erector spinae plane block for lumbar single level spine surgery 
Scientific Title of Study   Clinical efficacy of ultrasound guided bilateral erector spinae plane block for single level lumbar fusion surgery. A prospective, randomized, double blinded, case control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Not registered anywhere else  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vipin Kumar Goel 
Designation  Junior consultant 
Affiliation  Ganga hospitals and medical centre 
Address  Dept of Anaesthesiology, Ganga hospitals and medical centre, 313, mettupalayam road, Saibaba colony.

Coimbatore
TAMIL NADU
641043
India 
Phone    
Fax    
Email  drvipingoel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vipin Kumar Goel 
Designation  Junior consultant 
Affiliation  Ganga hospitals and medical centre 
Address  Dept of Anaesthesiology, Ganga hospitals and medical centre, 313, mettupalayam road, Saibaba colony.

Coimbatore
TAMIL NADU
641043
India 
Phone    
Fax    
Email  drvipingoel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vipin Kumar Goel 
Designation  Junior consultant 
Affiliation  Ganga hospitals and medical centre 
Address  Dept of Anaesthesiology, Ganga hospitals and medical centre, 313, mettupalayam road, Saibaba colony.

Coimbatore
TAMIL NADU
641043
India 
Phone    
Fax    
Email  drvipingoel@gmail.com  
 
Source of Monetary or Material Support  
Hospital Administration (Ganga Medical centre & Private hopsital Ltd) 313, mettupalayam road,Coimbatore-641043 
 
Primary Sponsor  
Name  Hospital administration 
Address  313, mettupalayam road, Sai baba colony, Coimbatore-641043 
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhanmohan C  Fifth floor orthopedic main operation theatre  Fifth floor orthopedic main operation theatre, Ganga medical centre and hospitals, Pvt. Ltd, 313, mettupalayam road, Saibaba colony
Coimbatore
TAMIL NADU 
09166774973

maddymbbs07@gmail.com 
Dr Vipin Kumar Goel  Orthopedic Operation theatre  Fifth floor orthopedic main operation theatre, Ganga Medical centre & Hospitals Private limited
Coimbatore
TAMIL NADU 
9443369715

drvipingoel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review board (IRB) GangaMedical centre & Hospitals Private Limited  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M488||Other specified spondylopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIl  No specific intervention will be done in this group. All anaesthetic management will remain the same except that this group will not receive the erector spinae block  
Intervention  Ultrasound guided bilateral erector spinae block for single level Lumbar fusion surgery  After general anesthesia is administered, patient will put on prone position. Then ultrasound will be used to identify the appropriate vertebral level (2 level above the vertebrae to be operated) and a high frequency linear-array ultrasound transducer (SonoSite, Bothell, WA, USA) covered in a sterile sleeve will be placed in a longitudinal parasagittal orientation 3 to 4 cm lateral to the midline to identify the tip of the transverse process. A 23G 90 mm Quincke’s spinal needle will be used in out of plane/ in plane technique to contact the transverse process. Correct needle tip position will be confirmed by hydro dissection by 1 ml of Saline solution followed by injection of 20 ml of Inj. Anawin 0.25% with 4 mg of dexamethasone. Correct drug placement will be confirmed by linear spread of the local anaesthetic drug separating the erector spinae muscle from the transverse processes. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Patients requiring single level fusion surgery at lumbar spine (L1 to L5) for degenerative and lytic changes

• ASA I and II patients
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. bleeding disorder
3. Local infection.
4. Patient who were on chronic drug therapy.
5. Adjacent segment disease requiring surgeries
6. Inflammatory or infective etiology
7. Foreign nationals
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Requirement of opioid analgesia in the perioperative period  At end of 48 hours from start of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of analgesia   Till when rescue analgesia is given 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "103"
Final Enrollment numbers achieved (India)="103" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/05/2019 
Date of Study Completion (India) 31/05/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Patients undergoing spine surgeries will have severe perioperative pain which leads to morbidity and demands adequate analgesia. Multimodal analgesia involving NSAIDS, intravenous paracetamol and steroids remains the mainstay for treating the pain in these patients. In spite of the adequate usage of the above drugs most of the patient might require opioids in the immediate postoperative period due to severity of pain. Regional anaesthesia in these cases is administered by giving the local anaesthetic in the epidural space or giving opioids epidurally or intrathecally, though they are rarely practised.  Erector spinae plane (ESP) block described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain by Forerro et al [1]. It has also been used for postoperative analgesia for breast surgery [2] and abdominal surgery [3]. With the advances in usage of ultrasound for regional anaesthesia, the performance of plane blocks have become much easier and more reliable. The erector spinae plane block is a myofascial plane block where the local anaesthetics are deposited in the plane between the erector spinae muscle and the transverse process of the vertebrae. The local anaesthetic thereby blocks the dorsal rami of the spinal nerves mainly and also ventral rami. We are studying the efficacy of ultrasound guided ESP block for perioperative analgesia on patients undergoing single level lumbar spine fusion surgery with control group.

 
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