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CTRI Number  CTRI/2021/06/034407 [Registered on: 25/06/2021] Trial Registered Prospectively
Last Modified On: 15/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of ultrasound guided injection of local anesthetic between back muscle planes to direct injection in and around the back muscles, for post operative pain relief after spine surgeries. 
Scientific Title of Study   COMPARISON OF BILATERAL ERECTOR SPINAE PLANE [ESP] BLOCK WITH LOCAL WOUND INFILTRATION OF ANESTHESIA [LWIA] FOR POST OPERATIVE ANALGESIC EFFICACY AFTER OPEN LUMBAR FUSION SURGERY- A PROSPECTIVE RANDOMISED TRIAL 
Trial Acronym  ESWILF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pankaj yadav 
Designation  DNB trainee 
Affiliation  Northern railway central hospital 
Address  Department of anesthesia, northern railway central hospital, basant lane , cannaught place, new delhi
Department of anesthesia, northern railway central hospital, basant lane , cannaught place, new delhi
New Delhi
DELHI
110055
India 
Phone  8376985101  
Fax    
Email  dr.pankaj1417@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sushil krishnan 
Designation  Assistant chief health director 
Affiliation  Northern railway central hospital 
Address  Department of anesthesia, northern railway central hospital, basant lane , cannaught place, new delhi
Department of anesthesia, northern railway central hospital, basant lane , cannaught place, new delhi
New Delhi
DELHI
110055
India 
Phone  9717630552  
Fax    
Email  dr.sushilkrishnan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pankaj yadav 
Designation  DNB trainee 
Affiliation  Northern railway central hospital 
Address  Department of anesthesia, northern railway central hospital, basant lane , cannaught place, new delhi
Department of anesthesia, northern railway central hospital, basant lane , cannaught place, new delhi
New Delhi
DELHI
110055
India 
Phone  8376985101  
Fax    
Email  dr.pankaj1417@gmail.com  
 
Source of Monetary or Material Support  
Northern railway central hospital 
 
Primary Sponsor  
Name  Northern railway central hospital 
Address  Northern railway central hospital, basant lane, cannaught place, new delhi 
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 
Pankaj yadav  Northern railway central hospital  Department of anesthesia, OT complex, ward no. 4.
New Delhi
DELHI 		 8376985101

dr.pankaj1417@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, northern railway central hospital, IEC-NRCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M51||Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  not applicable 
Intervention  Erector spinae plane (ESP) block  Ultrasound guided erector spinae plane (ESP) block using 15 ml of 0.375% ropivacaine on each side prior to surgery (total dose of ropivacaine 112.5 mg). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients aged 18-75 years old, with American Society of Anaesthesiologists Physical status 1-3 scheduled for open lumbar fusion surgery. 
 
ExclusionCriteria 
Details  1. Allergy or intolerance to any of the drugs used in the study.
2. Kidney, liver, central or peripheral neurologic disease, coagulopathy.
3. Pre-existing neurologic or anatomic deficits in the lower extremities.
4. Severe psychiatric illness.
5. Infection in the intervention region.
6. History of narcotic drug use within 24 hours before operation.
7. History of chronic pain, narcotic substance or alcoholic dependence. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objective of this study is to compare 24 hour post-operative cumulative analgesic consumption between erector spinae plane (ESP) block with local wound infiltration of anaesthesia (LWIA) after open lumbar spine fusion surgeries.  24 hours post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of static pain, scores between the 2 groups, as assessed by the verbal numeric rating scale (VNRS) at 0, 1, 6, 12 and 24 hours
2. Comparison of dynamic pain score between the 2 groups, as assessed by the verbal numeric rating scale (VNRS) at12 and 24 hours.
3. Comparison of quality of recovery (QOR-40) score between the 2 groups at postoperative day 2.
4. Postoperative nausea and vomiting will be noted and graded according to a standard PONV scoring system. 		 At 0, 1, 6, 12, 24 hours for static pain and at 12 and 24 hours for dynamic pain.
QOR-40 on day two. 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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 3/ Phase 4 
Date of First Enrollment (India)   30/06/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is a randomised control trial comparing the bilateral erector spinae plane [ESP] block with local wound infiltration of anaesthesia [LWIA] for post-operative analgesic efficacy after open lumbar fusion surgery in 46 patients aged 18-75, ASA grade 1-3. This study will be done in Northern Railway Central Hospital, New Delhi. The patients will be grouped into two groups A and B using computer generated numbers. Group A Patients will receive bilateral Erector Spinae Plane (ESP) block using 15 ml of 0.375% ropivacaine on each side prior to surgery [Total dose of ropivacaine 112.5mg]. Group B Patients will receive local infiltration using 22.5 ml of 0.5% ropivacaine at the end of surgery [Total dose of ropivacaine 112.5mg]. Comparision of 24 hour post operative cumulative analgesic consumption between the two groups will be done. Patients in both the groups will be followed for static pain at 0,1,6,12,24 hours using verbal numeric rating scale(VNRS) and dynamic pain at 12, 24 hours using VNRS. Comparision of quality of recovery (QOR-40) score between the two groups will be done at post operative day 2. Post operative nausea and vomiting will be noted And graded according to standard PONV scoring system.

 
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