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CTRI Number  CTRI/2024/12/078050 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Laparoscopic Cholecystectomy under Thoracic Spinal Anaesthesia 
Scientific Title of Study   Comparison of effect of levobupivacaine versus Ropivacaine on Pulmonary function in patients undergoing Laparoscopic Cholecystectomy under Segmental Thoracic Spinal Anaesthesia 
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 Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr S N Medical College Jodhpur  
Address  Main operation theater complex first floor Department of Anaesthesia MDM Hospital Dr S N Medical collage Jodhpur RAJASTHAN
124, Vaishali Avenue, Opposite B R Birla public School, Jodhpur (Rajasthan)
Jodhpur
RAJASTHAN
342008
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gamail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr S N Medical College Jodhpur  
Address  Main operation theater complex first floor Department of Anaesthesia MDM Hospital Dr S N Medical collage Jodhpur RAJASTHAN
124, Vaishali Avenue, Opposite B R Birla public School, Jodhpur (Rajasthan)
Jodhpur
RAJASTHAN
342008
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gamail.com  
 
Details of Contact Person
Public Query  
Name  Yashi Upadhyay 
Designation  Junior Resident 
Affiliation  Dr S N Medical Collage, Jodhpur 
Address  Main operation theater complex first floor Department of Anaesthesia MDM Hospital Dr S N Medical collage Jodhpur RAJASTHAN

Jodhpur
RAJASTHAN
342001
India 
Phone  9887660296  
Fax    
Email  yashuup10@gmail.com  
 
Source of Monetary or Material Support  
MDM Hospital Dr S N Medical collage Jodhpur RAJASTHAN 342001 India  
 
Primary Sponsor  
Name  MDM Hospital Dr S N Medical Collage Jodhpur RAJASTHAN  
Address  Main operation theater First floor MDM Hospital Dr S N Medical College Shastri Nagar Jodhpur Rajasthan 342001  
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 Geeta Singariya  MDM hospital Dr S N Medical collage Jodhpur  Main OT Complex First floor Department of anesthesia M D M Hospital Dr S N Medical College Shastri Nagar Jodhpur RAJASTHAN 342001
Jodhpur
RAJASTHAN 		 9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group Levobupivacaine (L)  Levobupivacaine 0.5% hyperbaric 10 mg (2ml) + 25 microgram fentanyl (0.5ml) will be given over 15 seconds intrathecally  
Comparator Agent  Group Ropivacaine (R)  Ropivacaine 0.75% hyperbaric 15mg (2ml) + 25 microgram fentanyl (0.5ml) will be given over 15 seconds intrathecally  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The patients, aged 18 to 60 years of
both genders belong to ASA PS I and II undergoing elective laparoscopic cholecystectomy. 
 
ExclusionCriteria 
Details  Patient’s refusal
Contraindications to spinal anaesthesia
 
 
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 
Comparison of pulmonary function tests, which includes measurements of the peak expiratory
flow rate (PEFR), forced vital capacity (FVC) and forced expiratory volume in first second (FEV1),
using hyperbaric levobupivacaine versus hyperbaric ropivacaine, in patients undergoing
laparoscopic cholecystectomy under segmental thoracic spinal anaesthesia.  		 3 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
Number of cases required to be converted to GA
Perioperative hemodynamic parameters
Postoperative VAS pain score
Time of request for first postoperative analgesia
Perioperative complications like nausea & vomiting, right shoulder pain, need for
antispasmodics, O2 saturation
Surgeon’s satisfaction & Patient’s satisfaction 		 24 hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 4 
Date of First Enrollment (India)   22/12/2024 
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 Applicable 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 28-12-2025 and end date provided 28-11-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study will be conducted at DR S N Medical College and associated groups of hospitals after seeking clearance from the institutional ethical committee and obtaining written informed consent from the patients. To ensure inclusion in the study, each patient will be subjected to a detailed pre-anaesthetic evaluation (PAE) based on a detailed history from the patient and a thorough physical examination as well as a preanesthetic airway assessment. The purpose and detailed procedure will be explained to the patients. We will measure the weight and height of each patient to obtain the exact BMI. Written informed consent will be obtained from all the patients regarding the procedure. Baseline investigations will be done in all the patients to rule out any abnormalities. Visual analogue scale (VAS) and demonstration of the correct usage of the spirometry device to the patient will be explained to all the patients in PAE during the pre-anesthetic visit. The evening before surgery, patients will be instructed to use the spirometer to simulate testing. All patients will be kept nil by mouth as per standard guidelines before the scheduled time of surgery. In the sitting position, either of the drugs will be aseptically administered through a 25G Quincke spinal needle by a midline approach between T8-T9 / T9 T10 intervertebral space. After the free flow of cerebrospinal fluid will be verified, local anaesthetic was given over 15 seconds, without aspiration. The anesthesiologist performing the spinal anaesthesia will be not aware of group allocation. A separate independent anesthesiologist will prepare all local anaesthetic solutions. Immediately after administration of spinal anaesthesia, the patients will be turned to a supine position. 
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