| 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
|
|
|
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
|
|
|
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
|
|
|
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. |