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CTRI Number  CTRI/2025/07/090942 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of two doses of isobaric levobupivacaine with fentanyl for segmental thoracic spinal anesthesia for laparoscopic cholecystectomy. 
Scientific Title of Study   Comparative evaluation of block characteristics of two doses of isobaric levobupivacaine with fentanyl for thoracic spinal anesthesia in patients undergoing laparoscopic cholecystectomy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankita Bansal 
Designation  secondary DNB 
Affiliation  NDMC medical college and Hindu rao hospital 
Address  First floor OT, Department of Anaesthesiology, NDMC medical college and Hindu rao hospital, Malka ganj, delhi

Central
DELHI
110007
India 
Phone  7011522193  
Fax    
Email  oops.ankita@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Duggal 
Designation  senior specialist 
Affiliation  NDMC medical college and Hindu rao hospital 
Address  Department of Anaesthesiology, NDMC medical college and Hindu rao hospital, Malka ganj, delhi

Central
DELHI
110007
India 
Phone  9810138257  
Fax    
Email  rashmi.duggal.10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankita Bansal 
Designation  secondary DNB 
Affiliation  NDMC medical college and Hindu rao hospital 
Address  First floor OT, Department of Anaesthesiology, NDMC medical college and Hindu rao hospital, Malka ganj, delhi

Central
DELHI
110007
India 
Phone  7011522193  
Fax    
Email  oops.ankita@gmail.com  
 
Source of Monetary or Material Support  
NDMC medical college and Hindu Rao Hospital, malka ganj, delhi-110007, India 
 
Primary Sponsor  
Name  NDMC medical college and Hindu rao hospital 
Address  NDMC medical college and hindu rao hospital, malkaganj, delhi-110007, India 
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 
Dr Ankita Bansal  NDMC medical college and Hindu Rao hospital  First floor OT, Department of Anaesthesiology, Hindu rao hospital, Malka ganj, delhi-110007
Central
DELHI 		 07011522193

oops.ankita@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: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  isobaric levobupivacaine 0.5%  comparison of block characteristics of two different doses that is 10mg and 7.5mg given in spinal anaesthesia for laparoscopic cholecystectomy. duration- 1 year  
Intervention  thoracic spinal anesthesia  feasiability of thoracic spinal anesthesia for laparoscopic cholecystectomy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  weight= 50-80kgs
height= 150-180cm
ASA grade 1 and 2
undergoing elective surgery 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
to compare time taken to achieve maximum level of sensory block  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
to compare sensory block characteristics  6 months 
to compare motor block characteristics  6 months 
to compare requirement of rescue analgesia  6 months 
to note hemodynamic changes & adverse effects if any.  6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   30/07/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [oops.ankita@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-07-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Laparoscopic cholecystectomy is the most common general surgery procedure for which general anesthesia has been gold standard. GA involves side effects of airway instrumentation and mechanical ventilation besides causing wide hemodynamic fluctuations. Regional anesthesia specifically thoracic spinal anesthesia is fast evolving technique for laparoscopic cholecystectomy especially in cases with significant medical problems and in those with high risk  for GA. Thoracic spinal anesthesia offers distinct benefits over GA such as enhanced hemodynamic stability, quicker recovery and postoperative analgesia especially in high risk patients for GA. Comparison of two different doses of isobaric levobupivacaine in thoracic spinal will enlighten us about block characteristics and hemodynamic changes in patients undergoing laparoscopic cholecystectomy in Indian population. 
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