| CTRI Number |
CTRI/2025/05/087028 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of isobaric Ropivacaine and isobaric Levobupivacaine with addition of Fentanyl in spinal anaesthesia for postoperative pain relief in patients posted for lower abdominal surgeries . |
|
Scientific Title of Study
|
To compare the efficacy of isobaric Ropivacaine 0.75 percent with isobaric Levobupivacaine 0.5 percent in spinal anaesthesia with inj Fentanyl as an adjuvant in patients posted for lower abdominal 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 |
Monika Varun Mittal |
| Designation |
Assistant professor |
| Affiliation |
Smt Kashibai Navale Medical College And Hospital |
| Address |
Third floor ,Department of anaesthesia ,smt kashibai navale medical college and general hospital .Narhe,Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9158224311 |
| Fax |
|
| Email |
monikatyagi1590@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika Varun Mittal |
| Designation |
Assistant professor |
| Affiliation |
Smt Kashibai Navale Medical College And Hospital |
| Address |
Third floor ,Department of anaesthesia ,smt kashibai navale medical college and general hospital .Narhe,Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9158224311 |
| Fax |
|
| Email |
monikatyagi1590@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Varun Mittal |
| Designation |
Assistant professor |
| Affiliation |
Smt Kashibai Navale Medical College And Hospital |
| Address |
Third floor ,Department of anaesthesia ,smt kashibai navale medical college and general hospital .Narhe,Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9158224311 |
| Fax |
|
| Email |
monikatyagi1590@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Monika Varun Mittal |
| Address |
Third floor ,Department of anaesthesia ,smt kashibai navale medical college and general hospital .Narhe,Pune 411041 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sumedha Mehta |
Department of anaesthesia , smt kashibai navale medical college and general hospital , narhe ,pune, 411041 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monika Varun Mittal |
Smt kashibai navale hospital |
Operation theater,Third floor ,Department of anaesthesia ,Smt kashibai navale medical college and general hospital .Narhe,Pune
Pune
MAHARASHTRA |
9158224311
monikatyagi1590@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| smt kashibai navale medical college and general hospital institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (2) ICD-10 Condition: N433||Hydrocele, unspecified, (3) ICD-10 Condition: N47||Disorders of prepuce, (4) ICD-10 Condition: K37||Unspecified appendicitis, (5) ICD-10 Condition: N35||Urethral stricture, (6) ICD-10 Condition: K419||Unilateral femoral hernia, withoutobstruction or gangrene, (7) ICD-10 Condition: K458||Other specified abdominal hernia without obstruction or gangrene, (8) ICD-10 Condition: N759||Disease of Bartholins gland, unspecified, (9) ICD-10 Condition: N768||Other specified inflammation of vagina and vulva, (10) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrathecal isobaric Levobupivacaine |
Inj levobupivacaine 0.5 percent isobaric 3ml along with inj Fentanyl 25 micrograms 0.5ml will be given intrathecally to the patients undergoing lower abdominal surgeries. |
| Comparator Agent |
Intrathecal isobaric Ropivacaine |
Inj Ropivacaine 0.75 percent isobaric 3ml along with inj Fentanyl 25 micrograms 0.5ml will be given intrathecally to the patients undergoing lower abdominal surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I &II patients
2.Patients posted for elective lower abdominal surgeries under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Contraindication to subarachnoid block.
3.Central or peripheral neuropathies
4.Patients with bleeding disorders and those on anticoagulant therapy.
5.History of allergy to local anaesthetics.
6.Infection at site of block.
7.Obesity
8.Pregnant women.
9 Patients with psychiatric behaviour
10. History of chronic opioid use |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Duration of postoperative Analgesia between two groups isobaric levobupivacaine with fentanyl and isobaric ropivacaine with fentanyl |
from the time of administration of study drug intrathecally to the patient complaint of pain postoperatively or VAS more than 3 postoperatively till 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparision of hemodynamic stability between two groups isobaric ropivacaine with fentanyl and isobaric levobupivavaine with fentanyl |
from the administration of drug in spinal till completion of surgery and postoperative till 24 hours |
| Comparision of adverse effects between two groups isobaric ropivacaine with fentanyl and isobaric levobupivavaine with fentanyl |
from the administration of drug in spinal till completion of surgery and postoperative till 24 hours |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/05/2025 |
| 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 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
|
Title of the study project is TO COMPARE THE EFFICACY OF ISOBARIC ROPIVACAINE AND ISOBARIC LEVOBUPIVACAINE IN SPINAL ANAESTHESIA WITH INJ FENTANYL AS AN ADJUVANT IN PATIENTS POSTED FOR LOWER ABDOMINAL SURGERIES.In our study we want to compare the efficacy of intrathecal isobaric ropivacaine 0.75 percent 3ML with fentanyl 25 mcg 0.5ml and isobaric levobupivacaine 0.5 percent 3ml with fentanyl 25 mcg 0.5 ml as adjuvant for the quality of anaesthesia and postoperative analgesia in patients undergoing elective lower abdominal surgeries .Primary objective is to compare the characteristics of blockade and duration of post operative analgesia between two groups.Secondary objectives are Comparison with respect to haemodynamic parameters and Comparison with respect to adverse effects and complications This study will be conducted at Smt Kashibai Navale Medical College and General Hospital Pune. After taking informed written consent, patients aged between 18 to 65 years of either sex will be randomly allocated into two groups using computer generated random number tables as Group RF in which patients will receive Intrathecal isobaric Ropivacaine 0.75 percent 3 ml with inj fentanyl 25mcg 0.5 ml and Group LF will receive Intrathecal hyperbaric Levobupivacaine 0.5 percent 3 ml with inj fentanyl 25mcg 0.5ml.Our hypothesis is that both sensory and motor blockade will be better with levobupivacaine as compared to ropivacaine and adding fentanyl as an adjuvant will increase the duration of postoperative analgesia
|