FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/034708 [Registered on: 09/07/2021] Trial Registered Prospectively
Last Modified On: 09/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare the efficacy of bilateral erector spinae block between two groups in spine fusion surgeries 
Scientific Title of Study   Efficacy of bilateral erector spinae block in patients undergoing posterior spine fusion surgeries -a comparative randomized 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  Suresh kumar 
Designation  Junior resident 
Affiliation  pondicherry institute of medical sciences 
Address  DEPARTMENT OF ANAESTHESIOLOGY,PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, KALAPET, PONDICHERRY.

Pondicherry
PONDICHERRY
605014
India 
Phone  8220123361  
Fax    
Email  murali71095@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arish BT 
Designation  Assistant professor 
Affiliation  pondicherry institute of medical sciences 
Address  DEPARTMENT OF ANAESTHESIOLOGY, PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, KALAPET, PONDICHERRY.

Pondicherry
PONDICHERRY
605014
India 
Phone  9791853400  
Fax    
Email  ajstyle.bt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arish BT 
Designation  Assistant professor 
Affiliation  pondicherry institute of medical sciences 
Address  DEPARTMENT OF ANAESTHESIOLOGY, PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, KALAPET, PONDICHERRY.

Pondicherry
PONDICHERRY
605014
India 
Phone  9791853400  
Fax    
Email  ajstyle.bt@gmail.com  
 
Source of Monetary or Material Support  
PONDICHERRY INSTITUTE OF MEDICAL SCIENCE KALAPET PUDUCHERRY 
 
Primary Sponsor  
Name  pondicherry institute of medical sciences 
Address  pondicherry institute of medical sciences,pondicherry 
Type of Sponsor  Private medical college 
 
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 
Suresh kumar   Pondicherry institute of medical science  department of anaesthesiology, pims, kalapet, pomdicherry
Pondicherry
PONDICHERRY 
8220123361

murali71095@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS institute ethics committee(IEC)  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 
Intervention  bilateral erector spinae block  Group B: patients will be receiving conventional general anaesthesia with bilateral ultrasound guided erector spinae block given with total volume of 40 ml 0.25 % bupivacaine drug. 
Comparator Agent  control group   Group A: patients will be receiving conventional general anaesthesia with total volume of 40 ml of normal saline (0.9% Nacl) block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Age group of 18-65 yrs.
2)both genders
3)American society of anaesthesiologist: I /II
4)Patient undergoing primary open posterior spine fusion surgeries under general anaesthesia.

 
 
ExclusionCriteria 
Details  1)patients BMI >35
2)History of Chronic opioid user
3)History of Patients with Coagulopathy
4)History of Patients with allergy to the study drug
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess postoperative pain by using Visual analog score (VAS) for the first 24 hours between erector spinae plane block and conventional general anaesthesia groups in spine surgery patients.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the hemodynamic parameters between erector spinae plane block and conventional general anaesthesia groups in spine surgery patients.
2.To determine the time for first opioid analgesia requirement in the postoperative period till 24 hours.
3.To determine the amount of cumulative opioid consumption between the groups during intraoperative and postoperative period till 24 hours.
 
1.To compare the hemodynamic parameters between erector spinae plane block and conventional general anaesthesia groups in spine surgery patients.
2.To determine the time for first opioid analgesia requirement in the postoperative period till 24 hours.
3.To determine the amount of cumulative opioid consumption between the groups during intraoperative and postoperative period till 24 hours.
 
 
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   N/A 
Date of First Enrollment (India)   12/07/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

           Spine surgeries cause excruciating pain in the postoperative period limiting the patient’s ability to ambulate. The pain following surgery is said to last as long as 3-4 days. In order to achieve an early recovery, adequate pain management in the perioperative is essential to avoid any untoward complications. Regional techniques offers the benefit of a better pain control, early recovery of bowel functions, lesser PONV and easier participation in physical therapies comparing systemic analgesics. In line with this, Erector spinae plane block has been in use since 2016 when Forero et al demonstrated its efficacy in mitigating thoracic neuropathic pain. Many research papers were published subsequently stating its varied applications in different surgeries like post thoracotomy pain syndrome, breast surgeries, chronic shoulder pain, ventral hernia repair, abdominal and hip surgeries Siam EM did a comparative study on 30 patients undergoing posterior spine fusion surgeries. The results of the study showed that ESP significantly reduced the stress response, decreased inhalational anaesthetic and also helped in achieving controlled hypotension. Similarly, bilateral erector spinae block was evaluated for postoperative analgesia in lumbar spine surgeries by Singh et al in 2019, were forty patients randomly assigned into two groups and observed all the 20 patients in the control group required additional morphine in the postoperative period when compared to only 9 patients in the ESP group. The pain scores were also higher in the control group compared to the study group. In the same year, the efficacy of ultrasound guided erector spinae block in 60 patients undergoing lumbar spinal decompression surgery as a postoperative analgesic was conducted by yayik. The results showed that the postoperative visual analog scale score was higher at rest and during active movement in the control group when compared to the study group. Also the time at which the first rescue analgesic required was significantly longer in the ESP group. In another study, zhang et al in 2020 found that patients who received preoperative erector spinae block and underwent open lumbar spine surgeries showed enhanced recovery as assessed by MOAA/S score. All these patients had an early ambulation and shorter hospital stay. Eskin et al in 2020 have shown that ultrasound guided erector spinae block for postoperative analgesia in lumbar spine surgeries clearly explains that postoperative pain which was assessed by VAS were constantly lower in study group when compared to control group and hence it results in lowering the first time of rescue analgesic in study group postoperatively for the first 24 hours. In 2019, breebaart conducted a study on efficacy of bilateral lumbar erector spinae block after posterior lumbar fusion surgery and concluded that ESP block is safer in muscle plane which concludes no risk of mechanical nerve injury, reduction in the opioid consumption in ESP block which results in faster recovery and early mobilization postoperatively.

 
Close