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CTRI Number  CTRI/2023/09/057570 [Registered on: 13/09/2023] Trial Registered Prospectively
Last Modified On: 14/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing pain relieving potential of giving Dexamethasone or Dexmedetomidine or Ketamine when given with 0.375% Ropivacaine for ultrasound guided erector spinae block in spinal surgery for pain relief 
Scientific Title of Study   Comparison of Efficacy of Dexamethasone vs Dexmedetomidine Vs Ketamine as Adjuvants to Ropivacaine 0.375% for Bilateral Ultrasound guided Erector Spinae Block for Spinal Instrumentation Surgery- A Randomized Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Eesha Banerjee 
Designation  DrNB Neuroanesthesia Resident 
Affiliation  Institute of Neurosciences Kolkata 
Address  2nd floor. Department of Neuroanesthesia and Critical Care. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal
2nd floor. Department of Neuroanesthesia and Critical Care. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal. 700017
Kolkata
WEST BENGAL
700017
India 
Phone    
Fax    
Email  eesha5banerjee70@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kallol Deb 
Designation  Senior Consultant  
Affiliation  Institute of Neurosciences Kolkata  
Address  2nd floor. Department of Neuroanesthesia and Critical Care. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal

Kolkata
WEST BENGAL
700017
India 
Phone  9830028915  
Fax    
Email  kalloldeb15@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kallol Deb 
Designation  Senior Consultant  
Affiliation  Institute of Neurosciences Kolkata  
Address  2nd floor. Department of Neuroanesthesia and Critical Care. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal

Kolkata
WEST BENGAL
700017
India 
Phone  9830028915  
Fax    
Email  kalloldeb15@gmail.com  
 
Source of Monetary or Material Support  
Institute of Neurosciences Kolkata. 185/1 A J C Bose Road, Kolkata. West Bengal. 700017 
 
Primary Sponsor  
Name  Institute of Neurosciences Kolkata  
Address  2nd floor. Department of Neuroanesthesia and Critical Care. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal 
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 Eesha Banerjee  Institute of Neurosciences Kolkata   2nd floor. Department of Neuroanesthesia and Critical Care. Institute of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal
Kolkata
WEST BENGAL 		 7501724995

eesha5banerjee70@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC INSTITUTE OF NEUROSCIENCES KOLKATA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M259||Joint disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bilateral ESP block with Dexamethsaone  Patients will receive Erector Spinae Block with 0.375% ropivacaine & dexamethasone 8 mg, combined to total volume of 40 ml, equally given as 20 ml on both sides. 
Intervention  Bilateral ESP Block with Dexmedetomidine  Patients will receive Erector Spinae Block with 0.375% ropivacaine & dexmedetomidine 0.8 mcg/kg ( maximum 50 mcg) combined to total volume of 40 ml, equally given as 20 ml on both sides. 
Intervention  Bilateral ESP Blovk with Ketamine  Patients will receive Erector Spinae Block with 0.375% ropivacaine & ketamine 1 mg/kg ( maximum 50 mg) combined to total volume of 40 ml, equally given as 20 ml on both sides. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Aged 18–65 years
ASA grade I, II
Either gender
BMI < 24 kg/m2
Surgical procedure: spinal instrumentation surgeries involving the dorso-lumbar spine (D10-S1)
Duration of surgery: up to 4 hours
 
 
ExclusionCriteria 
Details  Patient refusal
ASA Grade III/ IV
Surgeries:
Scoliosis correction surgery
Spinal instrumentation surgery planned under intraoperative neuro-monitoring
Revision spine surgery
Duration of surgery >4 hours,
Patients with hypersensitivity to any of the drugs in use
History of congestive heart failure/ valvular heart disease/ IHD/ cardiac conduction block/ renal dysfunction/ hepatic disease/ pulmonary disease/ neuropsychiatric disorders/ coagulation abnormality
Puncture site infection
History of chronic pain or central neuropathy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of duration of analgesia using VAS pain score  0 hr
2 hr
4 hr
8 hr
12 hr
24 hr 
 
Secondary Outcome  
Outcome  TimePoints 
Total intraoperative and postoperative opioid consumption   24 hr 
Intraoperative haemodynamic stability  10 min
20 min
30 min
1 hr
1.5 hr
2 hr
2.5 hr
3 hr
3.5 hr
4 hr 
First request of rescue analgesic   Anytime in first 24 hr 
Occurrence of PONV in postoperative period  Anytime in first 24 hr 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "115"
Final Enrollment numbers achieved (India)="115" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2023 
Date of Study Completion (India) 15/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

Pain is main concern for all patients undergoing surgery. Drugs like benzodiazepines (like Midazolam, Diazepam) and opioids (like Fentanyl) have been used with their known side effects. Enhanced Recovery After Anaesthesia (ERAS) emphasizes the use of regional anaesthesia for postoperative analgesia with the goal of it being opioid free. Erector spinae plane block (ESPB) is a novel regional anaesthesia technique, which is a useful intervention in thoracic neuropathic pain and acute pain after surgery. The placement of local anaesthetics only in the interfacial plane for the block has been well established since its inception of use in pain management. However, to further the duration of analgesia additives are being deposited perineural along with local anesthetics. Perineurally deposited dexmedetomidine, dexamethasone and ketamine has been historically in use for peripheral nerve blocks, which is now finding its place in truncal blocks. Thus, this study is being conducted to compare the efficacy of dexmedetomidine, dexamethasone and ketamine along with 0.375 % ropivacaine in erector spinae plane block to reduce postoperative pain in dorsolumbar spine surgeries.


 
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