| CTRI Number |
CTRI/2026/03/106741 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
22/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
COMPARATIVE ANALYSIS OF ANAESTHETIC DRUGS HYPERBARIC ROPIVACAINE AND HYPERBARIC BUPIVACAINE SAFETY IN PATIENTS UNDERGOING INFRA-UMBILICAL SURGERIES |
|
Scientific Title of Study
|
COMPARATIVE ANALYSIS OF ANAESTHETIC CHARACTERSTICS AND SAFETY OF INTRATHECAL 0.75% HYPERBARIC ROPIVACAINE AND 0.5% HYPERBARIC BUPIVACAINE IN PATIENTS UNDERGOING INFRA-UMBILICAL SURGERIES - A RANDOMIZED DOUBLE - BLIND STUDY |
| 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 MOHAMMED YUNUS KHILJI |
| Designation |
PROFESSOR |
| Affiliation |
Sardar Patel Medical College Bikaner Rajasthan India |
| Address |
Department of Anaesthesia Sardar Patel Medical College Bikaner RAJASTHAN 334001 India |
| Phone |
8587858715 |
| Fax |
|
| Email |
mohammedyunus.khilji@nhs.net |
|
Details of Contact Person Scientific Query
|
| Name |
DR RANU |
| Designation |
PG RESIDENT |
| Affiliation |
Sardar Patel Medical College Bikaner Rajasthan India |
| Address |
Department of Anaesthesia Sardar Patel Medical College Bikaner RAJASTHAN 334001 India |
| Phone |
8587858715 |
| Fax |
|
| Email |
drranu1109@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR MOHAMMED YUNUS KHILJI |
| Designation |
PROFESSOR |
| Affiliation |
Sardar Patel Medical College Bikaner Rajasthan India |
| Address |
Department of Anaesthesia Sardar Patel Medical College
RAJASTHAN 334001 India |
| Phone |
8587858715 |
| Fax |
|
| Email |
mohammedyunus.khilji@nhs.net |
|
|
Source of Monetary or Material Support
|
| DEPT. OF ANAESTHESIA ,
SARDAR PATEL MEDICAL COLLEGE,
BIKANER, RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner |
| Address |
DEPT. OF ANAESTHESIA , SARDAR PATEL MEDICAL COLLEGE, BIKANER, RAJASTHAN |
| Type of Sponsor |
Government medical college |
|
|
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 MOHAMMED YUNUS KHILJI |
Sardar Patel Medical College Bikaner |
Department of Anaesthesia
Sardar Patel Medical College
Bikaner
Rajasthan
India Bikaner RAJASTHAN |
8587858715
mohammedyunus.khilji@nhs.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE , SPMC BIKANER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (2) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (3) ICD-10 Condition: M220||Recurrent dislocation of patella, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% hyperbaric bupivacaine |
intrathecal |
| Intervention |
0.75% hyperbaric ropivacaine |
intrathecal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
BMI 18.5 TO 30 KG/M2
ELECTIVE INFRA UMBILICAL SUREGRY UNDER SPINAL ANAESTHESIA |
|
| ExclusionCriteria |
| Details |
KNOWN HYPERSENSITIVITY TO AMIDE TYPE LOCAL ANAESTHETICS
ASA 3and ABOVE
BLEEDING DISORDERS
LOCAL INFECTION |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE THE CHARACTERISTICS(ONSET AND DURATION) OF SENSORY BLOCK BETWEEN TWO GROUP |
Time to T10, 2min, 4min, 6min,8min, 10min.
peak sensory level
max bromage score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO DETERMINE THE ONSET AND DURATION OF MOTOR BLOCK,
TO DETERMINE QUALITY OF PERIOPERATIVE ANALGESIA |
FROM SPINAL ANAESTHESIA TO UPTO 10 MIN |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2026 |
| 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="0" Months="4" 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 - NO
|
|
Brief Summary
|
Regional anaesthesia plays a pivotal
role in providing effective pain relief and facilitating early recovery in
patients undergoing infra-umbilical surgeries.
Spinal Anaesthesia (Intrathecal
Anaesthesia) is a widely employed form of central neuraxial blockade.It
involves the injection of a local anaesthetic into the cerebrospinal fluid
(CSF) present in the subarachnoid space, typically between the L3-L4 or L4-L5
intervertebral space. This leads to reversible blockade of nerve conduction,
resulting in loss of sensation and muscle relaxation below the level of the
block.
Spinal anaesthesia is often favoured
over general anaesthesia for surgical procedures involving the lower abdomen
and lower limbs, owing to its numerous advantages such as the simplicity of
equipment, cost-effectiveness, provision of profound analgesia, satisfactory
muscle relaxation, reduced intra operative blood loss and minimal metabolic
disturbances.
Ropivacaine and Bupivacaine are two
long-acting local anaesthetics widely used in spinal anaesthesia. Both agents
are effective for producing adequate sensory and motor block.
Bupivcaine, introduced in 1956, is
an amino acid local anaesthetic comprising a racemic mixture of S- and
R-enantiomers. It has become a preferred agent for spinal anaesthesia due to
its ability to achieve effective sensory and motor blockade.
Bupivacaine has been associated with
several side effects including motor weakness, urinary retention and toxicity
affecting the cardiovascular and central nervous system.
Ropivacaine is a newer long-acting
amide local anaesthetic and the monohydrate of the hydrochloride salt of
1-propyl-2’,6’-pipecoloxylidide. It is the first clinically used pure S(-) enantiomeric local anaesthetic. It came into market in 1996. This contributes
to its lower risk of cardiovascular and central nervous system toxicity as
compared to bupivacaine.
Although numerous studies have
evaluated the use of ropivacaine for local infiltration, epidural and
peripheral nerve blocks. Clinical data regarding its characteristics following
intrathecal administration remain limited. |