| CTRI Number |
CTRI/2026/01/100244 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A research study comparing the analgesic efficacy of intrathecal levo bupivacine with fentanyl versus oral tizanidine |
|
Scientific Title of Study
|
Comparison of Analgesic efficacy of intrathecal Levobupivacaine with Fentanyl versus oral Tizanidine in 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 |
Sivasankari |
| Designation |
Junior resident PG Student |
| Affiliation |
AIIMS RAEBERALI |
| Address |
DEPT OF ANAESTHESIA 2ND FLOOR MAIN HOSPITAL
BUILDING AIIMS RAEBARELI DALMAU ROAD MUNSHIGANJ
RAEBARELI U P
Rae Bareli
UTTAR PRADESH
229405
India
DEPT OF ANAESTHESIA 2ND FLOOR MAIN HOSPITAL
BUILDING AIIMS RAEBARELI DALMAU ROAD MUNSHIGANJ
RAEBARELI U P
Rae Bareli
UTTAR PRADESH
229405
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8220195148 |
| Fax |
|
| Email |
shivashankari699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jameel Abdul Aleem |
| Designation |
Associate professor dept of anaesthesia |
| Affiliation |
AIIMS RAEBERALI |
| Address |
DEPT OF ANAESTHESIA 2ND FLOOR MAIN HOSPITAL
BUILDING AIIMS RAEBARELI DALMAU ROAD MUNSHIGANJ
RAEBARELI UP
Rae Bareli
UTTAR PRADESH
229405
India
DEPT OF ANAESTHESIA 2ND FLOOR MAIN HOSPITAL
BUILDING AIIMS RAEBARELI DALMAU ROAD MUNSHIGANJ
RAEBARELI UP
Rae Bareli
UTTAR PRADESH
229405
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8872278644 |
| Fax |
|
| Email |
meeraleem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sivasankari |
| Designation |
Junior resident PG Student |
| Affiliation |
AIIMS RAEBERALI |
| Address |
DEPT OF ANAESTHESIA 2ND FLOOR MAIN HOSPITAL
BUILDING AIIMS RAEBARELI DALMAU ROAD MUNSHIGANJ
RAEBARELI U P
Rae Bareli
UTTAR PRADESH
229405
India
DEPT OF ANAESTHESIA 2ND FLOOR MAIN HOSPITAL
BUILDING AIIMS RAEBARELI DALMAU ROAD MUNSHIGANJ
RAEBARELI U P
Rae Bareli
UTTAR PRADESH
229405
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8220195148 |
| Fax |
|
| Email |
shivashankari699@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RAEBERALI |
| Address |
AIIMS RAEBARELI DALMAU ROAD, MUNSHIGANJ RAEBARELI,
UP 229405 |
| 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 |
| Sivasankari |
AIIMS RAEBERALI |
DEPT OF ANAESTHESIA 2ND FLOOR MAIN HOSPITAL
BUILDING AIIMS RAEBARELI DALMAU ROAD MUNSHIGANJ
RAEBARELI U P
Rae Bareli
UTTAR PRADESH
229405
India
Rae Bareli
UTTAR PRADESH |
08220195148
shivashankari699@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NSTITUTIONAL ETHICS COMMITTEE, AIIMS RAEBARELI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison
of
analgesic
efficacy
of
Intrathecal
levobupivacaine with fentanyl versus oral tizanidine in infra
umbilical surgeries
|
Through the use of a computer-generated randomization table, they will be divided into groups T and F.Prior to surgery, all patients who will have elective infraumbilical surgeries and who meet our inclusion criteria will go through a Preanesthetic checkup according to institute
protocol. The complications and advantages of spinal anesthesia will be discussed with the patients. All the patients will be instructed to check in one day prior to surgery and to follow the recommended Nil Per Oral rules of 6 to 8 hours for solids and 2 hours for clear liquids.One hour prior to the surgery group T will receive oral tizanidine (4mg) with a sip of water given by a nursing officer. And for the both group T and F patients, ASA
standard monitoring devices will be attached when the patient enters the operating room.
|
| Intervention |
Group F: will receive 0.5% levobupivacaine (hyperbaric) 3ml +25mcg fentanyl in
subarachnoid block |
Group F will receive local anesthetic medication (injection
levobupivacaine 3ml + 25 mcg Fentanyl) which will be injected intrathecally using a 25-
gauge needle into the L3-L4 interspace by a trained anaesthetist |
| Comparator Agent |
Group T: will receive 0.5% levobupivacaine (hyperbaric) 3ml subarachnoid block+ 4mg
tizanidine (orally 1 hour before surgery).
|
After taking baseline vital readings, patient will be positioned
in sitting or left/right lateral. Group T will receive local anesthetic medication (injection
levobupivacaine 3ml) which will be injected intrathecally using a 25-gauge needle into
the L3-L4 interspace. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patient of ASA grade I-II between age 18-60 years, who are undergoing elective
infraumbilical surgeries.
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Coagulopathy
Cerebrovascular disease
Systemic infection
Allergy to local anesthetics
Psychopathy that may affect patient evaluation
Infection at site of injection
Kidney diseases
Liver diseases
Myelopathy or Peripheral Neuropathy
Spinal Stenosis
Previous Spine Surgery
Raised intracranial pressure
Multiple sclerosis
Spina bifida
Patients taking thromboprophylaxis
Inability to understand the study protocol
Patient refusal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the duration of anesthesia between the
Levobupivacaine with fentanyl versus oral Tizanidine in patients undergoing
infra umbilical surgeries. |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the post operative analgesic efficacy between the
Levobupivacaine with fentanyl versus oral Tizanidine in patients undergoing
infraumbilical surgeries.
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
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
|
This is a randomised control trial.Comparing the analgesic efficacy of Intrathecal levobupivacaine with fentanyl versus oral tizanidine in infra umbilical surgeries that is being conducted in AIIMS Raeberali.The primary outcome To compare the duration of anesthesia and post operative analgesic efficacy between the Levobupivacaine with fentanyl versus oral Tizanidine in patients undergoing infraumbilical surgeries. |