FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/01/030754 [Registered on: 27/01/2021] Trial Registered Prospectively
Last Modified On: 27/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparision of Erector Spinae block and Fentanyl PCA in lumbar spine surgeries. 
Scientific Title of Study   Comparison of bilateral ultrasound guided low thoracic erector spinae block and intravenous patient controlled fentanyl infusion for post-operative analgesia in lumbar surgeries – a randomised control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavya Mittimanj 
Designation  Senior Resident 
Affiliation  Sakra World Hospital 
Address  Department of Anaesthesia, OT complex, Second floor, SY NO 52, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru, Karnataka

Bangalore
KARNATAKA
560103
India 
Phone  9741694879  
Fax    
Email  drkavyamittimanj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Rajappa 
Designation  Associate Consultant 
Affiliation  Sakra World Hospital 
Address  Department of Anaesthesia, OT complex, Second floor, SY NO 52, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru, Karnataka

Bangalore
KARNATAKA
560103
India 
Phone  8437374321  
Fax    
Email  drdeepak.r4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Rajappa 
Designation  Associate Consultant 
Affiliation  Sakra World Hospital 
Address  Department of Anaesthesia, OT complex, Second floor, SY NO 52, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru, Karnataka

Bangalore
KARNATAKA
560103
India 
Phone  8437374321  
Fax    
Email  drdeepak.r4@gmail.com  
 
Source of Monetary or Material Support  
Sakra World Hospital, Bangalore 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  Department of Anaesthesia, Sakra World Hospital, SY NO 52/2 & 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru, Karnataka 560103 
Type of Sponsor  Private hospital/clinic 
 
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 Deepak Rajappa  Sakra World Hospital  Department of Anaesthesia, OT complex, Second floor, SY NO 52/2 & 52/3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru, Karnataka 560103
Bangalore
KARNATAKA 		 8437374321

drdeepak.r4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutinal Ethics Committee, Sakra World Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M498||Spondylopathy in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparision in Fentanyl consumption in patients with or without Erector Spinae Block.  All patients receive Fentanyl PCA in the postoperative period, the total consumption will be seen at the end of 24 hours.  
Intervention  Erector Spinae Block in one of the group.  Under all aseptic precautions, the blocks will be performedin prone position after induction of anesthesia .Standard 7 Mhzlinear ultrasound transducer will be sagittally placed against T10/T12 vertebral level and moved approximately 3-4 cms lateral to the spinous process. The erector spinae muscle will be identified, and a 22G, 5 cm stimuplex insulated needle (Stimuplex® A50, B Braun, Melsungen, Germany) will beintroduced from craniocaudal direction and advanced through the interfascial plane between the erector spinae and the underlying transverse process of T10/ T12 verterbrae (depending on the level of surgery done, usually 2 vertebral level above the surgery); thereafter, the local anaesthetic (20 ml of 0.375% Ropivacaine and 2 mg dexamethasone) will be administered into the space.The same will be repeated on the opposite side. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing Lumbar spine surgeries. 
 
ExclusionCriteria 
Details  1. No consent from the patient’s care-giver/ patients or attendant refusal.
2. Patients having history coronary artery disease, documented clinical or echo cardiac evidence of left ventricular dysfunction.
3. History of cognitive dysfunction / delirium.
4. History of Opioid use.
5. History of anticoagulation or any bleeding disorder.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Difference of total dose of fentanyl used in first 24 hours of post-operative period in the 2 groups.  1, 2, 4, 8, 12, 18 & 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in pain score(VAS)  1, 2, 4, 8, 12, 18 & 24 hours 
Time for ambulation  1, 2, 4, 8, 12, 18 & 24 hours 
Length of hospital stay  1, 2, 4, 8, 12, 18 & 24 hours 
Adverse effects of opioids:
a. Nausea vomiting
b. Ileus
c. Pruritis
d. Drowsiness
 		 1, 2, 4, 8, 12, 18 & 24 hours 
Block related complications
a. Hypotension
b. Local anaesthesia toxicity/allergy
c. Vascular puncture
d. Infection
e. Pleural puncture / Pneumothorax
f. Failed block
 		 1, 2, 4, 8, 12, 18 & 24 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2021 
Date of Study Completion (India) 25/11/2021 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Majority of the patients undergoing lumbar fusion spine surgery is associated with severe postoperative painespecially in the first post-operative period.1The pain is proportional to the number of operated vertebrae and the invasiveness of the procedure.2 Pain management following spine surgery   largely relies on opioid based protocols, which are associated with adverse effects like nausea, vomiting, pruritis, sedation and risk of long-term habituation and dependence.3 Epidural analgesia is considered gold standard for management of pain, but is associated with its own complication like interference with surgery and intrathecal migration of local anaesthetic drug.4Multimodal approaches to pain management has been demonstrated to allow for improved pain control with less reliance on opioids.5 One of the modes of multimodal analgesia is peripheral nerve blocks and interfascial plane blocks. Erector spinae plane (ESP) block is an interfascial plane blockshown to be effective in most of the thoracic surgeries.Only a few case report and case series are available regarding use of erector spinae block in lumbar surgeries.

 
Close