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CTRI Number  CTRI/2023/07/055014 [Registered on: 10/07/2023] Trial Registered Prospectively
Last Modified On: 02/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of efficacy in pain relief ,change in pulse rate, blood pressure and surgeons’ satisfaction between general anaesthesia with local anaesthetic in between lumbar vertebra and erector spine muscle and local anaesthetic injected in spinal space in lumbar spine surgery 
Scientific Title of Study   Comparison of perioperative analgesic efficacy , haemodynamics and surgeons’ satisfaction between general anaesthesia with erector spinae plane block along with spinal anaesthesia in lumbar spine surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MD AZIZ BILLAHA 
Designation  JUNIOR RESIDENT 
Affiliation  R. G. KAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Anaesthesiology Neurosurgery Operation Theatre Trauma Building , 2nd floor R. G. KAR MEDICAL COLLEGE AND HOSPITAL 1, Kshudiram Bose Sarani, Kolkata – 700004
1, Kshudiram Bose Sarani, Kolkata – 700004
Kolkata
WEST BENGAL
700004
India 
Phone  8583841295  
Fax    
Email  azizbillaha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saikat Niyogi 
Designation  Professor 
Affiliation  R. G. KAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Anaesthesiology Neurosurgery operation theatre Trauma Building, 2nd floor R. G. KAR MEDICAL COLLEGE AND HOSPITAL 1, Kshudiram Bose Sarani, Kolkata – 700004
1, Kshudiram Bose Sarani, Kolkata – 700004
Kolkata
WEST BENGAL
700004
India 
Phone  9831732443  
Fax    
Email  saikatneuro1972@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MD AZIZ BILLAHA 
Designation  JUNIOR RESIDENT 
Affiliation  R. G. KAR MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Anaesthesiology Neurosurgery Operation Theatre Trauma Building , 2nd floor R. G. KAR MEDICAL COLLEGE AND HOSPITAL 1, Kshudiram Bose Sarani, Kolkata – 700004
1, Kshudiram Bose Sarani, Kolkata – 700004
Kolkata
WEST BENGAL
700066
India 
Phone  8583841295  
Fax    
Email  azizbillaha@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT MEDICAL COLLEGE 
 
Primary Sponsor  
Name  R. G. KAR MEDICAL COLLEGE AND HOSPITAL 
Address  1, Kshudiram Bose Sarani, Kolkata – 700004 
Type of Sponsor  Government 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 
MD AZIZ BILLAHA  R .G. Kar Medical College And Hospital  Department of Anaesthesiology Neurosurgery Operation Theatre Trauma Building , 2nd floor 1, Kshudiram Bose Sarani, Kolkata – 700004
Kolkata
WEST BENGAL 
8583841295

azizbillaha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector spinae plane block with Bupivacaine and Fentanyl  A single administration of 20 ml study drug preparation [bupivacaine (0.25%) 19 ml + fentanyl 1 ml (50 mcg) ] into the target plane between the erector spinae muscles and the transverse process in each side 30 minutes before operation  
Intervention  Intratheacal Bupivacaine heavy with Fentanyl  A single administration of subarachnoid block with 15mg bupivacaine heavy with 25 mcg fentanyl prior to operation  
Comparator Agent  Nil  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Posted for one or two level lumbar discectomy/laminectomy ( L3 , L4 , L5)

2. ASA Grade 1 and 2 patients

3. Age between 18-60 years of either sex

4. Patients with BMI between 20-30
 
 
ExclusionCriteria 
Details  1.Uncooperative patients or refusal.
2. ASA Grade 3 or above
3. Duration of surgery more than 2 hours
4. Cardiac and neurological diseases.
5. Uncontrolled Diabetes and Hypertension.
6. Chronic Obstructive Pulmonary Disease and Bronchial Asthma.
7. Bleeding disorder
8. On psychiatric medication.
9. Known allergy to the drug used.
10. Epilepsy.
11. Any kind of preexisting neuropathy.
12. Alcoholism.
13. Chronic opioid use (Defined as daily and almost daily use of opioids for more than 3 months).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Duration of analgesia in both groups in terms of VAS score
2) Total analgesic requirement in first 24 hours in both group
 
duration of analgesia is defined as time interval between complete sensory block and time of first rescue analgesia 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative surgeons satisfaction in terms of 5point Likert scale  It will be assessed immediately after completion of operation , preferably after 2 hours from start of operation 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   17/07/2023 
Date of Study Completion (India) 06/03/2024 
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 Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

The study was a randomized single blinded interventional study and conducted in R.G Kar Medical College and Hospital, Kolkata with the primary objective of comparing  the duration of analgesia in between GES (General anesthesia with ESPB) and SA group in terms of first dose of rescue analgesia and, secondary objective of observing perioperative hemodynamic changes, intraoperative blood loss , surgeons’ satisfaction and postoperative nausea,  vomiting in between these two groups. The study was done on a total 80 patients divided in two  groups( 40 patients in each group) in a span of one year.

ASA I & II patients and patients not having any major co-morbidity were included in the study. They were explained the process well & valid consent was taken . After all routine investigations, pre anesesthetic check up and overnight fasting GES group  were administered bilateral USG guided ESPB followed by GA and SA group were administered spinal anesthesia in sitting position. Intra-operative vitals (HR, SBP, DBP, MAP , SPO2) were recorded every 15 minutes interval. VAS score for pain  along with haemodynamic parameters were assessed at 1hr, 2 hr, 4 hr, 6 hr, 12 hr and 24 hr.postoperatively. All the patients were instructed to inform when VAS score for pain   > 4 then rescue analgesia  given with IV Tramadol at a dose of  2mg/kg  which were repeated every 6 hours until pain score becomes < 2.  Over the next 24 hr,  PONV was also  monitored. If nausea  scores were greater than 50, antiemetic therapy with  Inj Ondansetron 4 mg IV was administered which was repeated every 8 hours , if necessary , until vomiting ceased or nausea scores decreased to less than 20.  Surgeon’s satisfaction  using 5 point Likert scale and Blood loss using Boezzart’s scale were recorded after completion of surgery

 

 

This study has shown that GA with ultrasound guided ESPB can provide prolong analgesia and less analgesic requirement in first 24 hours post operative period in comparison to SA. It also shows us that there was better surgeons’ satisfaction in GES group than SA group. But there is more blood loss in GES group. Whereas there was no difference in terms of perioperative hemodynamic changes and PONV.
 
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