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CTRI Number  CTRI/2026/02/103040 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Postoperative Pain Relief using Two Spinal Anesthesia Drugs in Surgeries done below the Belly Button 
Scientific Title of Study   Comparing Efficacy Of Post Operative Analgesia Between Hyperbaric Levobupivacaine 0.5 Percentage And Hyperbaric Ropivacaine 0.75 Percentage Intrathecally In All Infra Umbilical Surgeries 
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 K Cheran 
Designation  Professor 
Affiliation  Vinayaka Missions Medical College and Hospital  
Address  Room no 1, Department of Anaesthesiology, Vinayaka Missions Medical College and Hospital, Keezhakasakudimedu, Kottuchery post, Karaikal, Puducherry-609609
Keezhakasakudimedu, Kottuchery post, Karaikal, Puducherry-609609
Karaikal
PONDICHERRY
609609
India 
Phone  9443144652  
Fax    
Email  anscheran.k73@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jahid Basha 
Designation  Post Graduate/Junior Resident 
Affiliation  Vinayaka Missions Medical College and Hospital 
Address  Room no 2, Department of Anaesthesiology, Vinayaka Missions Medical College and Hospital, Keezhakasakudimedu, Kottuchery post, Karaikal, Puducherry-609609
Keezhakasakudimedu, Kottuchery post, Karaikal, Puducherry-609609
Karaikal
PONDICHERRY
609609
India 
Phone  9176959862  
Fax    
Email  Jahid.basha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jahid Basha 
Designation  Post Graduate/Junior Resident 
Affiliation  Vinayaka Missions Medical College and Hospital 
Address  Room no 2, Department of Anaesthesiology, Vinayaka Missions Medical College and Hospital, Keezhakasakudimedu, Kottuchery post, Karaikal, Puducherry-609609
Keezhakasakudimedu, Kottuchery post, Karaikal, Puducherry-609609

PONDICHERRY
609609
India 
Phone  9176959862  
Fax    
Email  Jahid.basha@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Vinayaka Missions Medical College and Hospital 
Address  Vinayaka Missions Medical College and Hospital, Keezhakasakudimedu, Kottuchery post, Karaikal, Puducherry-609609 
Type of Sponsor  Research institution and hospital 
 
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 Jahid Basha  Vinayaka Missions Medical College and Hospital  Room no.4, Department of Anaesthesiology, Vinayaka Missions Medical College and Hospital, Keezhakasakudimedu, Kottuchery post, Karaikal, Puducherry-609609
Karaikal
PONDICHERRY 
9176959862

jahid.basha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTUTITIONAL ETHICAL 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  Group A  Patients receive spinal anaesthesia with Hyperbaric Levobupivacaine 0.5 percentage (Heavy) prior to infraumbilical surgeries 
Comparator Agent  Group B  Patients receive spinal anaesthesia with Hyperbaric Ropivacaine 0.75 percentage (Heavy) prior to infraumbilical surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - ASA Class 1 and 2

- Body Mass Index less than 35 kg per metre square.

- Surgery of less than 2 hours duration
 
 
ExclusionCriteria 
Details  - ASA Class 3 and 4

- Pregnancy

- Patients with Severe Spinal Deformity

- Patients with BMI more than 35 Kg per metre square

- Patients Allergic to Amide drugs
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of onset and time taken to Regain Sensory and Motor Neuraxial Blockade (via bromage scale)  0,2,4,6,12 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Reducing analgesic overdose  0,2,4,6,12 Hours post operatively 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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/ Phase 3 
Date of First Enrollment (India)   18/02/2026 
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 - NO
Brief Summary  

Spinal anaesthesia is widely used for lower abdominal and lower limb surgeries as it provides effective pain relief, ease of administration, and early recovery with minimal side effects. Various local anaesthetic drugs are used for spinal anaesthesia, and their effects on postoperative pain relief and recovery differ.

Levobupivacaine is a long-acting local anaesthetic with lower cardiac and neurological toxicity, while ropivacaine is a shorter-acting drug that allows faster recovery of motor function. This study aims to compare the effectiveness of intrathecal hyperbaric levobupivacaine and hyperbaric ropivacaine in providing postoperative analgesia in infra-umbilical surgeries.

This prospective, single-blinded, randomized controlled study will be conducted at Vinayaka Mission’s Medical College and Hospital, Karaikal. Sixty-two patients aged 18 to 60 years, belonging to ASA physical status I or II, scheduled for elective lower abdominal or lower limb surgeries lasting less than two hours will be included.

Participants will be randomly allocated into two groups. Group A will receive intrathecal hyperbaric levobupivacaine 0.5%, and Group B will receive intrathecal hyperbaric ropivacaine 0.75%. Postoperative pain will be assessed using the Visual Analogue Scale during the first 12 hours. Recovery of sensory and motor block, need for rescue analgesics, haemodynamic changes, and adverse events will be recorded and compared.

 
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