FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076737 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 05/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Evaluation of drugs hyperbaric levobupivacaine and hyperbaric ropivacaine for infra umbilical surgeries under spinal anesthesia. 
Scientific Title of Study   A comparative evaluation of hyperbaric levobupivacaine and hyperbaric ropivacaine for elective infra umbilical surgeries under spinal anaesthesia: A randomized 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  Dr Suhas Kumar Mall 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences. Gorakhpur. 
Address  Trauma and Emergency Medicine Department. All India Institute of Medical Sciences. Kunraghat. Gorakhpur. Uttar Pradesh.

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8238038707  
Fax    
Email  drsuhasmall@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suhas Kumar Mall 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences. Gorakhpur. 
Address  Trauma and Emergency Medicine Department. All India Institute of Medical Sciences. Kunraghat. Gorakhpur. Uttar Pradesh.

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8238038707  
Fax    
Email  drsuhasmall@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suhas Kumar Mall 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences. Gorakhpur. 
Address  Trauma and Emergency Medicine Department. All India Institute of Medical Sciences. Kunraghat. Gorakhpur. Uttar Pradesh.

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8238038707  
Fax    
Email  drsuhasmall@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences. kunraghat,Gorakhpur, Uttar Pradesh. 273008 
 
Primary Sponsor  
Name  Dr Suhas Kumar Mall 
Address  Trauma and Emergency Medicine Department. All India Institute of Medical Sciences. Kunraghat, Gorakhpur.273008. Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
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 Suhas Kumar Mall  All India Institute of Medical Sciences. Gorakhpur.  Ground Floor, Trauma and Emergency Medicine Department.
Gorakhpur
UTTAR PRADESH 		 8238038707
-
drsuhasmall@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee. All India Institute of Medical Sciences. Gorakhpur. UP.  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, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5%% hyperbaric levobupivacaine and 0.5% hyperbaric ropivacaine  Patients Group R will receive intrathecal((Subarachnoid block) dose of 15mg (3 ml) of 0.5% hyperbaric ropivacaine.observation up to 24 hours 
Intervention  Elective infra-umbilical surgeries under spinal anesthesia  Patient Group L will receive intrathecal(Subarachnoid block) dose of 15mg (3 ml) of 0.5% hyperbaric levobupivacaine. observation up to 24 hours. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  a) Patients of the American Society of Anesthesiologists I, II, and III.
b) Weight 40-80 kg
c) Elective infra umbilical surgeries of approximately 2 ½ hrs.
d) Patients who have given informed written consent.

 
 
ExclusionCriteria 
Details  a) Patient refusal.
b) Infection.
c) Coagulopathy.
d) LSCS.
e) Spinal deformity.
f) Patients of American Society of Anesthesiologists IV.
g) Allergic to local anesthetic drugs.
h) H/O seizures and neurological deficit.
i) Severe renal, hepatic, respiratory and cardiovascular disease.
j) Lack of informed written consent.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the time to onset of sensory block, time to peak sensory block and duration of sensory block.   Time to onset of sensory and motor block after giving drug. Time of duration of sensory and motor block till the next 24 hours and intraoperative hemodynamic monitoring every 1,3,5,10,15 mins and then every 15mins for the next 2 hours.
 
 
Secondary Outcome  
Outcome  TimePoints 
(a) To determine the time to onset of sensory block, time to peak sensory block & duration of sensory block.
(b) To determine the time to complete motor block & duration of motor block.
(c) To determine the duration of analgesia.
(d) Intraoperative haemodynamics.
(e) Postoperative recovery profile.
(f) Complications (If Any )
 		 Time to onset of sensory & motor block after giving drug. Time of duration of sensory & motor block till the next 24 hours & intraoperative hemodynamic monitoring every 1,3,5,10,15 mins & then every 15mins for the next 2 hours. 
 
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 4 
Date of First Enrollment (India)   18/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Spinal anaesthesia is an easy inexpensive and preferable technique for elective below umbilical surgeries. This study will compare the clinical effect, safety, and postoperative recovery profile of hyperbaric levobupivacaine and hyperbaric ropivacaine for elective below umbilical surgeries under Spinal anaesthesia. We will determine the time to onset of sensory block, time to peak sensory block, duration of sensory block, time to complete the motor block, duration of the motor block, duration of analgesia, intraoperative hemodynamic, postoperative recovery profile and Complications (If Any ). It’s a Prospective, randomized and comparative study of duration of 2 years, conducted at patients coming to All India Institute of Medical Sciences, Gorakhpur, which falls in the inclusion criteria. All samples collected during the above-mentioned period will be included in this study. Minimum of 60 patients; 30 in each group. Patients will be divided into: GROUP R: Patients in this group received intrathecal 15 mg (3 ml) of 0.5% hyperbaric Ropivacaine. GROUP L: Patients in this group received intrathecal 15 mg (3 ml) of 0.5% hyperbaric Levobupivacaine. Patients will be given drugs as per the opening of the envelope and after following the standard protocol of consent, attaching a multipara monitor and aseptic measure, spinal is given. The objectives will be measured at a specific time duration and patient data will be documented in the specified group. The data will be compared and the conclusion and discussion will be made as per the available results. 
Close