| CTRI Number |
CTRI/2025/11/096987 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PROSPECTIVE RANDOMIZED STUDY OF INTRATHECAL INJECTION TRAMADOL VERSUS INJECTION FENTANYL AS ADJUVANT WITH INJECTION LEVOBUPIVACAINE (0.5%) AS POST OPERATIVE ANALGESIA FOR INFRAUMBILICAL SURGERIES |
|
Scientific Title of Study
|
PROSPECTIVE RANDOMIZED STUDY OF INTRATHECAL INJECTION TRAMADOL VERSUS INJECTION FENTANYL AS ADJUVANT WITH INJECTION LEVOBUPIVACAINE (0.5%) AS POST OPERATIVE ANALGESIA FOR INFRAUMBILICAL 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 |
Prajwala Mundawad |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri institute of medical sciences and research centre |
| Address |
Anaesthesia department, ground floor , Sapthagiri institute of medical sciences and research centre , 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
8495040973 |
| Fax |
|
| Email |
prajwalasmundawad25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra babu |
| Designation |
Professor |
| Affiliation |
Sapthagiri institute of medical sciences and research centre |
| Address |
Anaesthesia department, ground floor , Sapthagiri institute of medical sciences and research centre , 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9900214064 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra babu |
| Designation |
Professor |
| Affiliation |
Sapthagiri institute of medical sciences and research centre |
| Address |
Anaesthesia department, ground floor , Sapthagiri institute of medical sciences and research centre , 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9900214064 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of Medical Sciences and Research Centre Department of Anaesthesiology Ground Floor OT Complex |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 |
| Type of Sponsor |
Private 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 |
| Prajwala Mundawad |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of Anaesthesiology
Ground Floor OT Complex, #15 Hesarghatta Main Road, Chikkabanavara, Bangalore, Karnataka
Bangalore
KARNATAKA |
8495040973
prajwalasmundawad25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infra umbilical surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection fentanyl with injection levobupivacaine |
Injection fentanyl 25mcg with injection levobupivacaine (0.5%) 2.5ml intrathecal injection |
| Comparator Agent |
Injection tramadol with injection levobupivacaine |
Injection tramadol 25mg with injection levobupivacaine (0.5%) 2.5ml intrathecal injection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Posted for Elective Infraumbilical Surgeries under Spinal Anesthesia
2.Age: 18-60 Years either Sex
3.Patient Willing to give written informed consent
4.ASA grade I or II |
|
| ExclusionCriteria |
| Details |
1. Patients with allergy to study drugs
2. Patients with contraindications for spinal anaesthesia
3. Pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia |
Loss of pin-prick sensation after subarachnoid block every 2 minutes in first 20 minutes. Until T10 Dermatome is reached. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| |
|
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="6"
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
|
Patients fulfilling the inclusion criteria and under going infra umbilical surgeries will be assessed to compare the efficiency of intrathecal tramadol versus fentanyl as adjuvant to Inj.levobupivacaine heavy(0.5%) for duration of post operative analgesia |