| CTRI Number |
CTRI/2024/10/074657 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A Randomized Study Comparing Ropivacaine and Bupivacaine with Fentanyl for Lower Abdominal Surgeries: Effects on Pain Management and Patient Outcomes." |
|
Scientific Title of Study
|
Comparison of Isobaric 0.75 Ropivacaine with fentanyl versus Hyperbaric 0.5 Bupivacaine with fentanyl in Spinal anaesthesia 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 |
Dr Deepak R |
| Designation |
Senior Resident |
| Affiliation |
BJ govt medical college, Pune |
| Address |
Dept of Anesthesiology, first floor, BJ Govt Medical College, Pune
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8983741147 |
| Fax |
|
| Email |
deepaknr0609@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak R |
| Designation |
Senior Resident |
| Affiliation |
BJ govt medical college, Pune |
| Address |
Dept of Anesthesiology, first floor, BJ Govt Medical College, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8983741147 |
| Fax |
|
| Email |
deepaknr0609@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak R |
| Designation |
Senior Resident |
| Affiliation |
BJ govt medical college, Pune |
| Address |
Dept of Anesthesiology, first floor, BJ Govt Medical College, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8983741147 |
| Fax |
|
| Email |
deepaknr0609@gmail.com |
|
|
Source of Monetary or Material Support
|
| BJ Govt Medical College, Jai Prakash Narayan Road, Railway Station Rd, Agarkar Nagar, Pune, Maharashtra,India 411001 |
|
|
Primary Sponsor
|
| Name |
Dr Deepak R |
| Address |
Dept of Anaesthesiology, BJ Govt Medical College, Pune
Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Deepak R |
BJ govt medical college, Pune |
Major OT, First Floor, Ward no. 11, B.J. Govt Medical College, Pune-411001
Pune
MAHARASHTRA |
08983741147
deepaknr0609@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, B.J. Govt Medical College and Sassoon General Hospital, Pune |
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 |
| Comparator Agent |
Bupivacaine group |
Group B will receive a single intrathecal administration of hyperbaric 0.5% bupivacaine combined with fentanyl once, just before the surgical procedure.. |
| Intervention |
Ropivacaine isobaric |
Group A will receive a single intrathecal administration of isobaric 0.75% ropivacaine combined with fentanyl just before the surgical procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective infraumbilical surgical procedures
2. Surgeries performed under spinal anesthesia
3. Surgical duration anticipated to be within 2 hours 30 minutes.
|
|
| ExclusionCriteria |
| Details |
1. Patients with bleeding disorders
2. ASA III and IV patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic changes associated with isobaric 0.75% ropivacaine with fentanyl versus hyperbaric 0.5% bupivacaine with fentanyl during spinal anesthesia for infraumbilical surgery. |
Before Induction, During Induction, 3 minutes, 6 minutes, 9 minutes, 12 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes, 135 minutes, 150 minutes, 165 minutes, 180 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the duration of onset of sensory and motor blockade between the two anesthetic combinations.
2. To assess the quality of sensory and motor blockade provided by each anesthetic regimen.
3. To evaluate the incidence and nature of adverse drug reactions associated with each anesthetic combination.
|
Before Induction, During Induction, 3 minutes, 6 minutes, 9 minutes, 12 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes, 135 minutes, 150 minutes, 165 minutes, 180 minutes. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/10/2024 |
| 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="3"
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
|
Spinal anesthesia is a preferred technique for
infraumbilical surgeries due to its effectiveness and safety profile. While
bupivacaine is commonly used, ropivacaine has emerged as a potential
alternative, offering a favorable cardiovascular safety profile. This study
aims to compare the hemodynamic changes, onset duration, quality of sensory and
motor blockade, and adverse drug reactions between
isobaric 0.75% ropivacaine with fentanyl and
hyperbaric 0.5% bupivacaine with fentanyl. |